Pierre Margent, MD

To date, men undergoing screening through the measurement of prostate-specific antigen (PSA) levels have had a significant reduction in neoplastic mortality. Because of its low specificity, however, this practice often leads to frequent, unnecessary, invasive biopsies and the diagnosis of low-grade, indolent cancer. While guided biopsies with multiparametric MRI can improve the diagnosis of grade 2 prostate cancers, widespread implementation remains challenging. The use of noninvasive biomarkers to stratify the risk for prostate cancer may be a more practical option.

The National Comprehensive Cancer Network proposes a test consisting of six blood and urine biomarkers for all grades of prostate cancer, and it outperforms PSA testing. However, current practice focuses on detecting high-grade cancers. It has been hypothesized that increasing the number of biomarkers by including molecules specifically expressed in aggressive high-grade prostate cancers could improve test accuracy. Based on the identification of new genes that are overexpressed in high-grade cancers, a polymerase chain reaction (PCR) technique targeting 54 candidate markers was used to develop an optimal 18-gene test that could be used before imaging (with MRI) and biopsy and to assess whether the latter procedures are warranted.
 

Development Cohort

In the development cohort (n = 815; median age, 63 years), quantitative PCR (qPCR) analysis of the 54 candidate genes was performed on urine samples that had been prospectively collected before biopsy following a digital rectal examination. Patients with previously diagnosed prostate cancer, abnormal MRI results, and those who had already undergone a prostate biopsy were excluded. Participants’ PSA levels ranged from 3 to 10 ng/mL (median interquartile range [IQR], 5.6 [4.6-7.2] ng/mL). Valid qPCR results were obtained from 761 participants (93.4%). Subsequently, prostate biopsy revealed grade 2 or higher cancer in 293 participants (38.5%).

Thus, a urine test called MyProstateScore 2.0 (MPSA) was developed, with two formulations: MPSA2 and MPSA2+, depending on whether a prostate volume was considered. The final MPSA2 development model included clinical data and 17 of the most informative markers, including nine specific to cancer, which were associated with the KLK3 reference gene.
 

Validation and Analyses

The external validation cohort (n = 813) consisted of participants in the NCI EDRN PCA3 Evaluation trial. Valid qPCR results were obtained from 743 participants, of whom 151 (20.3%) were found to have high-grade prostate cancer.

The median MPS2 score was higher in patients with grade 2 or higher prostate cancer (0.44; IQR, 0.23-0.69) than in those with noncontributory biopsies (0.08; IQR, 0.03-0.19; P < .001) or grade 1 cancer (0.25; IQR, 0.09-0.48; P < .01).

Comparative analyses included PSA, the Prostate Cancer Prevention Trial risk calculator, the Prostate Health Index (PHI), and various previous genetic models. Decision curve analyses quantified the benefit of each biomarker studied. The 151 participants with high-grade prostate cancer had operating curve values ranging from 0.60 for PSA alone to 0.77 for PHI and 0.76 for a two-gene multiplex model. The MPSA model had values of 0.81 and 0.82 for MPSA2+. For a required sensitivity of 95%, the MPS2 model could reduce the rate of unnecessary initial biopsies in the population by 35%-42%, with an impact of 15%-30% for other tests. Among the subgroups analyzed, MPS2 models showed negative predictive values of 95%-99% for grade 2 or higher prostate cancers and 99% for grade 3 or higher tumors.
 

MPS2 and Competitors

Existing biomarkers have reduced selectivity in detecting high-grade prostate tumors. This lower performance has led to the development of a new urine test including, for the first time, markers specifically overexpressed in high-grade prostate cancer. This new MPS2 test has a sensitivity of 95% for high-grade prostate cancer and a specificity ranging from 35% to 51%, depending on the subgroups. For clinicians, widespread use of MPS2 could greatly reduce the number of unnecessary biopsies while maintaining a high detection rate of grade 2 or higher prostate cancer.

Among patients who have had a negative first biopsy, MPS2 would have a sensitivity of 94.4% and a specificity of 51%, which is much higher than other tests like prostate cancer antigen 3 gene, three-gene model, and MPS. In addition, in patients with grade 1 prostate cancer, urinary markers for high-grade cancer could indicate the existence of a more aggressive tumor requiring increased monitoring.

This study has limitations, however. The ethnic diversity of its population was limited. A few Black men were included, for example. Second, a systematic biopsy was used as the reference, which can increase negative predictive value and decrease positive predictive value. Classification errors may have occurred. Therefore, further studies are needed to confirm these initial results and the long-term positive impact of using MPS2.

In conclusion, an 18-gene urine test seems to be more relevant for diagnosing high-grade prostate cancer than existing tests. It could prevent additional imaging or biopsy examinations in 35%-41% of patients. Therefore, the use of such tests in patients with high PSA levels could reduce the potential risks associated with prostate cancer screening while preserving its long-term benefits.

This story was translated from JIM, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

To date, men undergoing screening through the measurement of prostate-specific antigen (PSA) levels have had a significant reduction in neoplastic mortality. Because of its low specificity, however, this practice often leads to frequent, unnecessary, invasive biopsies and the diagnosis of low-grade, indolent cancer. While guided biopsies with multiparametric MRI can improve the diagnosis of grade 2 prostate cancers, widespread implementation remains challenging. The use of noninvasive biomarkers to stratify the risk for prostate cancer may be a more practical option.

The National Comprehensive Cancer Network proposes a test consisting of six blood and urine biomarkers for all grades of prostate cancer, and it outperforms PSA testing. However, current practice focuses on detecting high-grade cancers. It has been hypothesized that increasing the number of biomarkers by including molecules specifically expressed in aggressive high-grade prostate cancers could improve test accuracy. Based on the identification of new genes that are overexpressed in high-grade cancers, a polymerase chain reaction (PCR) technique targeting 54 candidate markers was used to develop an optimal 18-gene test that could be used before imaging (with MRI) and biopsy and to assess whether the latter procedures are warranted.
 

Development Cohort

In the development cohort (n = 815; median age, 63 years), quantitative PCR (qPCR) analysis of the 54 candidate genes was performed on urine samples that had been prospectively collected before biopsy following a digital rectal examination. Patients with previously diagnosed prostate cancer, abnormal MRI results, and those who had already undergone a prostate biopsy were excluded. Participants’ PSA levels ranged from 3 to 10 ng/mL (median interquartile range [IQR], 5.6 [4.6-7.2] ng/mL). Valid qPCR results were obtained from 761 participants (93.4%). Subsequently, prostate biopsy revealed grade 2 or higher cancer in 293 participants (38.5%).

Thus, a urine test called MyProstateScore 2.0 (MPSA) was developed, with two formulations: MPSA2 and MPSA2+, depending on whether a prostate volume was considered. The final MPSA2 development model included clinical data and 17 of the most informative markers, including nine specific to cancer, which were associated with the KLK3 reference gene.
 

Validation and Analyses

The external validation cohort (n = 813) consisted of participants in the NCI EDRN PCA3 Evaluation trial. Valid qPCR results were obtained from 743 participants, of whom 151 (20.3%) were found to have high-grade prostate cancer.

The median MPS2 score was higher in patients with grade 2 or higher prostate cancer (0.44; IQR, 0.23-0.69) than in those with noncontributory biopsies (0.08; IQR, 0.03-0.19; P < .001) or grade 1 cancer (0.25; IQR, 0.09-0.48; P < .01).

Comparative analyses included PSA, the Prostate Cancer Prevention Trial risk calculator, the Prostate Health Index (PHI), and various previous genetic models. Decision curve analyses quantified the benefit of each biomarker studied. The 151 participants with high-grade prostate cancer had operating curve values ranging from 0.60 for PSA alone to 0.77 for PHI and 0.76 for a two-gene multiplex model. The MPSA model had values of 0.81 and 0.82 for MPSA2+. For a required sensitivity of 95%, the MPS2 model could reduce the rate of unnecessary initial biopsies in the population by 35%-42%, with an impact of 15%-30% for other tests. Among the subgroups analyzed, MPS2 models showed negative predictive values of 95%-99% for grade 2 or higher prostate cancers and 99% for grade 3 or higher tumors.
 

MPS2 and Competitors

Existing biomarkers have reduced selectivity in detecting high-grade prostate tumors. This lower performance has led to the development of a new urine test including, for the first time, markers specifically overexpressed in high-grade prostate cancer. This new MPS2 test has a sensitivity of 95% for high-grade prostate cancer and a specificity ranging from 35% to 51%, depending on the subgroups. For clinicians, widespread use of MPS2 could greatly reduce the number of unnecessary biopsies while maintaining a high detection rate of grade 2 or higher prostate cancer.

Among patients who have had a negative first biopsy, MPS2 would have a sensitivity of 94.4% and a specificity of 51%, which is much higher than other tests like prostate cancer antigen 3 gene, three-gene model, and MPS. In addition, in patients with grade 1 prostate cancer, urinary markers for high-grade cancer could indicate the existence of a more aggressive tumor requiring increased monitoring.

This study has limitations, however. The ethnic diversity of its population was limited. A few Black men were included, for example. Second, a systematic biopsy was used as the reference, which can increase negative predictive value and decrease positive predictive value. Classification errors may have occurred. Therefore, further studies are needed to confirm these initial results and the long-term positive impact of using MPS2.

In conclusion, an 18-gene urine test seems to be more relevant for diagnosing high-grade prostate cancer than existing tests. It could prevent additional imaging or biopsy examinations in 35%-41% of patients. Therefore, the use of such tests in patients with high PSA levels could reduce the potential risks associated with prostate cancer screening while preserving its long-term benefits.

This story was translated from JIM, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

To date, men undergoing screening through the measurement of prostate-specific antigen (PSA) levels have had a significant reduction in neoplastic mortality. Because of its low specificity, however, this practice often leads to frequent, unnecessary, invasive biopsies and the diagnosis of low-grade, indolent cancer. While guided biopsies with multiparametric MRI can improve the diagnosis of grade 2 prostate cancers, widespread implementation remains challenging. The use of noninvasive biomarkers to stratify the risk for prostate cancer may be a more practical option.

The National Comprehensive Cancer Network proposes a test consisting of six blood and urine biomarkers for all grades of prostate cancer, and it outperforms PSA testing. However, current practice focuses on detecting high-grade cancers. It has been hypothesized that increasing the number of biomarkers by including molecules specifically expressed in aggressive high-grade prostate cancers could improve test accuracy. Based on the identification of new genes that are overexpressed in high-grade cancers, a polymerase chain reaction (PCR) technique targeting 54 candidate markers was used to develop an optimal 18-gene test that could be used before imaging (with MRI) and biopsy and to assess whether the latter procedures are warranted.
 

Development Cohort

In the development cohort (n = 815; median age, 63 years), quantitative PCR (qPCR) analysis of the 54 candidate genes was performed on urine samples that had been prospectively collected before biopsy following a digital rectal examination. Patients with previously diagnosed prostate cancer, abnormal MRI results, and those who had already undergone a prostate biopsy were excluded. Participants’ PSA levels ranged from 3 to 10 ng/mL (median interquartile range [IQR], 5.6 [4.6-7.2] ng/mL). Valid qPCR results were obtained from 761 participants (93.4%). Subsequently, prostate biopsy revealed grade 2 or higher cancer in 293 participants (38.5%).

Thus, a urine test called MyProstateScore 2.0 (MPSA) was developed, with two formulations: MPSA2 and MPSA2+, depending on whether a prostate volume was considered. The final MPSA2 development model included clinical data and 17 of the most informative markers, including nine specific to cancer, which were associated with the KLK3 reference gene.
 

Validation and Analyses

The external validation cohort (n = 813) consisted of participants in the NCI EDRN PCA3 Evaluation trial. Valid qPCR results were obtained from 743 participants, of whom 151 (20.3%) were found to have high-grade prostate cancer.

The median MPS2 score was higher in patients with grade 2 or higher prostate cancer (0.44; IQR, 0.23-0.69) than in those with noncontributory biopsies (0.08; IQR, 0.03-0.19; P < .001) or grade 1 cancer (0.25; IQR, 0.09-0.48; P < .01).

Comparative analyses included PSA, the Prostate Cancer Prevention Trial risk calculator, the Prostate Health Index (PHI), and various previous genetic models. Decision curve analyses quantified the benefit of each biomarker studied. The 151 participants with high-grade prostate cancer had operating curve values ranging from 0.60 for PSA alone to 0.77 for PHI and 0.76 for a two-gene multiplex model. The MPSA model had values of 0.81 and 0.82 for MPSA2+. For a required sensitivity of 95%, the MPS2 model could reduce the rate of unnecessary initial biopsies in the population by 35%-42%, with an impact of 15%-30% for other tests. Among the subgroups analyzed, MPS2 models showed negative predictive values of 95%-99% for grade 2 or higher prostate cancers and 99% for grade 3 or higher tumors.
 

MPS2 and Competitors

Existing biomarkers have reduced selectivity in detecting high-grade prostate tumors. This lower performance has led to the development of a new urine test including, for the first time, markers specifically overexpressed in high-grade prostate cancer. This new MPS2 test has a sensitivity of 95% for high-grade prostate cancer and a specificity ranging from 35% to 51%, depending on the subgroups. For clinicians, widespread use of MPS2 could greatly reduce the number of unnecessary biopsies while maintaining a high detection rate of grade 2 or higher prostate cancer.

Among patients who have had a negative first biopsy, MPS2 would have a sensitivity of 94.4% and a specificity of 51%, which is much higher than other tests like prostate cancer antigen 3 gene, three-gene model, and MPS. In addition, in patients with grade 1 prostate cancer, urinary markers for high-grade cancer could indicate the existence of a more aggressive tumor requiring increased monitoring.

This study has limitations, however. The ethnic diversity of its population was limited. A few Black men were included, for example. Second, a systematic biopsy was used as the reference, which can increase negative predictive value and decrease positive predictive value. Classification errors may have occurred. Therefore, further studies are needed to confirm these initial results and the long-term positive impact of using MPS2.

In conclusion, an 18-gene urine test seems to be more relevant for diagnosing high-grade prostate cancer than existing tests. It could prevent additional imaging or biopsy examinations in 35%-41% of patients. Therefore, the use of such tests in patients with high PSA levels could reduce the potential risks associated with prostate cancer screening while preserving its long-term benefits.

This story was translated from JIM, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Tracheal intubation is recommended for comatose patients, but its use in individuals with altered consciousness due to acute poisoning remains uncertain. A French team conducted a large randomized trial to assess the risk–benefit ratio of a conservative approach in this context.

Patients with altered consciousness are at high risk for respiratory distress and pneumonia. Acute poisoning, whether from alcohol, drugs, or medications, is a nontraumatic cause of altered consciousness that often leads to intubation. In the United States alone, 20,000 patients with acute poisoning are intubated annually. While this practice aims to prevent the inhalation of gastric content and, consequently, pneumonia, intubation itself can cause hemodynamic instability, hypoxia, difficulties during tube insertion, or dental injuries. Until now, no study had attempted to evaluate the risk–benefit ratio of this practice in cases of toxic coma.
 

A Randomized Trial

The randomized trial conducted with a parallel, nonblinded design aimed to determine whether abstaining from intubation was equivalent to standard practice in certain situations. The study took place in 20 French emergency services and one intensive care unit. Participants were at least 18 years old with suspected acute poisoning and a Glasgow Coma Scale (GCS) score of less than 9. Pregnant women; prisoners; those requiring immediate intubation because of respiratory distress, cerebral edema, or other critical conditions; and those using cardiotoxic drugs or drugs that could be rapidly antagonized, such as opioids or sedatives, were excluded. Participants were randomized in a 1:1 ratio after hospital stratification. In the control group, the decision to intubate was at the discretion of the attending practitioner.

In the nonintubated by default group (the intervention group), a procedure could be performed later in case of respiratory distress, vomiting, or other complications. If abstaining, patients were closely monitored through oximetry, heart rate, GCS, etc. If intubation was required, it was performed under sedation (sedatives or hypnotics) and succinylcholine or rocuronium, after appropriate preoxygenation. In addition, capnography was recommended later to ensure proper endotracheal tube placement.

The primary outcome was a hierarchical composite outcome combining in-hospital death, duration of stay in the intensive care unit (ICU), and overall hospital stay (up to the 28th day). Secondary outcomes included, besides the aforementioned individual outcomes, the number of patients requiring mechanical ventilation, the proportion of admissions to the ICU, the incidence of pneumonia, and iatrogenic effects related to intubation itself.
 

Noninvasive Strategy’s Advantages

The primary analysis included 225 participants, and 116 were in the intervention arm. The average age was 33 years, and 38% were women. The median GCS at inclusion was 6. Alcohol was the most frequently implicated toxin, accounting for 67% of observations. Fewer intubations were observed in the intervention group: 19 (16.4%) versus 63 (57.8%). Of the 19 patients eventually intubated in the intervention group, 16 had met at least one emergency intubation criterion. No deaths were recorded across the entire cohort.

In the intervention group, the median duration of stay in the ICU was 0 hours compared with 24.0 hours in the control group, resulting in a relative risk of 0.39. Hospitalization duration was 21.5 hours in the intervention group, compared with 37.0 hours, yielding a relative risk of 0.74. The win ratio (a method of analyzing composite parameters that prioritizes the most clinically significant event) for the composite criterion was 1.85 (P < .001). In a prespecified subgroup analysis, this ratio was 1.70 (P = .02) when the GCS was below 7. It was 1.42 when poisoning was caused by alcohol, benzodiazepines, gamma-hydroxybutyric acid, or gamma-butyrolactone.

It is essential to note, however, that this trial was not conducted blindly, and the Hawthorne effect may have influenced the physician’s decision to intubate or not. Conversely, the study’s strengths include a substantial cohort (225 patients), consideration of various parameters beyond pneumonia from aspiration, with a relative risk reduction of 53%. In addition, the etiology of toxic coma was not established in all cases. Finally, in cases of intubation, the use of a video laryngoscope or stylets was not specified.

In conclusion, for comatose patients with suspected acute poisoning, a conservative strategy aiming to avoid intubation as much as possible is associated with superior clinical benefits, in terms of the composite outcome of in-hospital mortality, duration of stay in intensive care or the hospital, and a decrease in adverse events.
 

This article was translated from JIM, which is part of the Medscape Professional Network.  A version of this article appeared on Medscape.com.

Tracheal intubation is recommended for comatose patients, but its use in individuals with altered consciousness due to acute poisoning remains uncertain. A French team conducted a large randomized trial to assess the risk–benefit ratio of a conservative approach in this context.

Patients with altered consciousness are at high risk for respiratory distress and pneumonia. Acute poisoning, whether from alcohol, drugs, or medications, is a nontraumatic cause of altered consciousness that often leads to intubation. In the United States alone, 20,000 patients with acute poisoning are intubated annually. While this practice aims to prevent the inhalation of gastric content and, consequently, pneumonia, intubation itself can cause hemodynamic instability, hypoxia, difficulties during tube insertion, or dental injuries. Until now, no study had attempted to evaluate the risk–benefit ratio of this practice in cases of toxic coma.
 

A Randomized Trial

The randomized trial conducted with a parallel, nonblinded design aimed to determine whether abstaining from intubation was equivalent to standard practice in certain situations. The study took place in 20 French emergency services and one intensive care unit. Participants were at least 18 years old with suspected acute poisoning and a Glasgow Coma Scale (GCS) score of less than 9. Pregnant women; prisoners; those requiring immediate intubation because of respiratory distress, cerebral edema, or other critical conditions; and those using cardiotoxic drugs or drugs that could be rapidly antagonized, such as opioids or sedatives, were excluded. Participants were randomized in a 1:1 ratio after hospital stratification. In the control group, the decision to intubate was at the discretion of the attending practitioner.

In the nonintubated by default group (the intervention group), a procedure could be performed later in case of respiratory distress, vomiting, or other complications. If abstaining, patients were closely monitored through oximetry, heart rate, GCS, etc. If intubation was required, it was performed under sedation (sedatives or hypnotics) and succinylcholine or rocuronium, after appropriate preoxygenation. In addition, capnography was recommended later to ensure proper endotracheal tube placement.

The primary outcome was a hierarchical composite outcome combining in-hospital death, duration of stay in the intensive care unit (ICU), and overall hospital stay (up to the 28th day). Secondary outcomes included, besides the aforementioned individual outcomes, the number of patients requiring mechanical ventilation, the proportion of admissions to the ICU, the incidence of pneumonia, and iatrogenic effects related to intubation itself.
 

Noninvasive Strategy’s Advantages

The primary analysis included 225 participants, and 116 were in the intervention arm. The average age was 33 years, and 38% were women. The median GCS at inclusion was 6. Alcohol was the most frequently implicated toxin, accounting for 67% of observations. Fewer intubations were observed in the intervention group: 19 (16.4%) versus 63 (57.8%). Of the 19 patients eventually intubated in the intervention group, 16 had met at least one emergency intubation criterion. No deaths were recorded across the entire cohort.

In the intervention group, the median duration of stay in the ICU was 0 hours compared with 24.0 hours in the control group, resulting in a relative risk of 0.39. Hospitalization duration was 21.5 hours in the intervention group, compared with 37.0 hours, yielding a relative risk of 0.74. The win ratio (a method of analyzing composite parameters that prioritizes the most clinically significant event) for the composite criterion was 1.85 (P < .001). In a prespecified subgroup analysis, this ratio was 1.70 (P = .02) when the GCS was below 7. It was 1.42 when poisoning was caused by alcohol, benzodiazepines, gamma-hydroxybutyric acid, or gamma-butyrolactone.

It is essential to note, however, that this trial was not conducted blindly, and the Hawthorne effect may have influenced the physician’s decision to intubate or not. Conversely, the study’s strengths include a substantial cohort (225 patients), consideration of various parameters beyond pneumonia from aspiration, with a relative risk reduction of 53%. In addition, the etiology of toxic coma was not established in all cases. Finally, in cases of intubation, the use of a video laryngoscope or stylets was not specified.

In conclusion, for comatose patients with suspected acute poisoning, a conservative strategy aiming to avoid intubation as much as possible is associated with superior clinical benefits, in terms of the composite outcome of in-hospital mortality, duration of stay in intensive care or the hospital, and a decrease in adverse events.
 

This article was translated from JIM, which is part of the Medscape Professional Network.  A version of this article appeared on Medscape.com.

Tracheal intubation is recommended for comatose patients, but its use in individuals with altered consciousness due to acute poisoning remains uncertain. A French team conducted a large randomized trial to assess the risk–benefit ratio of a conservative approach in this context.

Patients with altered consciousness are at high risk for respiratory distress and pneumonia. Acute poisoning, whether from alcohol, drugs, or medications, is a nontraumatic cause of altered consciousness that often leads to intubation. In the United States alone, 20,000 patients with acute poisoning are intubated annually. While this practice aims to prevent the inhalation of gastric content and, consequently, pneumonia, intubation itself can cause hemodynamic instability, hypoxia, difficulties during tube insertion, or dental injuries. Until now, no study had attempted to evaluate the risk–benefit ratio of this practice in cases of toxic coma.
 

A Randomized Trial

The randomized trial conducted with a parallel, nonblinded design aimed to determine whether abstaining from intubation was equivalent to standard practice in certain situations. The study took place in 20 French emergency services and one intensive care unit. Participants were at least 18 years old with suspected acute poisoning and a Glasgow Coma Scale (GCS) score of less than 9. Pregnant women; prisoners; those requiring immediate intubation because of respiratory distress, cerebral edema, or other critical conditions; and those using cardiotoxic drugs or drugs that could be rapidly antagonized, such as opioids or sedatives, were excluded. Participants were randomized in a 1:1 ratio after hospital stratification. In the control group, the decision to intubate was at the discretion of the attending practitioner.

In the nonintubated by default group (the intervention group), a procedure could be performed later in case of respiratory distress, vomiting, or other complications. If abstaining, patients were closely monitored through oximetry, heart rate, GCS, etc. If intubation was required, it was performed under sedation (sedatives or hypnotics) and succinylcholine or rocuronium, after appropriate preoxygenation. In addition, capnography was recommended later to ensure proper endotracheal tube placement.

The primary outcome was a hierarchical composite outcome combining in-hospital death, duration of stay in the intensive care unit (ICU), and overall hospital stay (up to the 28th day). Secondary outcomes included, besides the aforementioned individual outcomes, the number of patients requiring mechanical ventilation, the proportion of admissions to the ICU, the incidence of pneumonia, and iatrogenic effects related to intubation itself.
 

Noninvasive Strategy’s Advantages

The primary analysis included 225 participants, and 116 were in the intervention arm. The average age was 33 years, and 38% were women. The median GCS at inclusion was 6. Alcohol was the most frequently implicated toxin, accounting for 67% of observations. Fewer intubations were observed in the intervention group: 19 (16.4%) versus 63 (57.8%). Of the 19 patients eventually intubated in the intervention group, 16 had met at least one emergency intubation criterion. No deaths were recorded across the entire cohort.

In the intervention group, the median duration of stay in the ICU was 0 hours compared with 24.0 hours in the control group, resulting in a relative risk of 0.39. Hospitalization duration was 21.5 hours in the intervention group, compared with 37.0 hours, yielding a relative risk of 0.74. The win ratio (a method of analyzing composite parameters that prioritizes the most clinically significant event) for the composite criterion was 1.85 (P < .001). In a prespecified subgroup analysis, this ratio was 1.70 (P = .02) when the GCS was below 7. It was 1.42 when poisoning was caused by alcohol, benzodiazepines, gamma-hydroxybutyric acid, or gamma-butyrolactone.

It is essential to note, however, that this trial was not conducted blindly, and the Hawthorne effect may have influenced the physician’s decision to intubate or not. Conversely, the study’s strengths include a substantial cohort (225 patients), consideration of various parameters beyond pneumonia from aspiration, with a relative risk reduction of 53%. In addition, the etiology of toxic coma was not established in all cases. Finally, in cases of intubation, the use of a video laryngoscope or stylets was not specified.

In conclusion, for comatose patients with suspected acute poisoning, a conservative strategy aiming to avoid intubation as much as possible is associated with superior clinical benefits, in terms of the composite outcome of in-hospital mortality, duration of stay in intensive care or the hospital, and a decrease in adverse events.
 

This article was translated from JIM, which is part of the Medscape Professional Network.  A version of this article appeared on Medscape.com.