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Carbon Monoxide-induced Coma: Prognostic Factors (Coma-CO)
| Condition or disease |
|---|
| Coma Carbon Monoxide Poisoning |
Carbon monoxide is a leading cause of poison related lethality in France. Moreover, survivors may develop severe neuro-cognitive sequelae. Few studies sought to determine prognostic factors related to CO induced coma.
Coma is defined as a Glasgow coma score of < 8. Neurological sequels will be considered persistent when present at hospital discharge.
This is a retrospective observational study. All comatose patients with Glasgow coma score < 8 due to carbon monoxide poisoning, treated by hyperbaric oxygen therapy in a tertiary hospital in the Île de France area, will be included in the study. Clinical, biological, iconographic and electrophysiological data collected from patient's medical files between January 2000 to December 2018 will be analysed retrospectively.
Statistics
Base-line characteristics will be summarized using tabulated Statistics, namely median [interquartile range, IQR] or percentages (*"Statistics") unless specified.
Exact Fisher tests will be used to compare distribution of binary outcomes, while nonparametric Wilcoxon rank sum tests will be used for comparison of continuous variables.
Logistic regression models will be used to measure the strength of association of the variables with the outcomes, by odds ratio (OR), either unadjusted or adjusted in multivariable models.
Multivariate imputation by chained equations (MICE) will be used as the method of dealing with missing data in covariates. It operates under the assumption that given the variables used in the imputation procedure, the missing data are Missing At Random (MAR), which means that the probability that a value is missing depends only on observed values and not on unobserved values. A total of m = 30 imputed datasets will be generated, with Rubin's rules applied thereafter to provide mean estimates of the ORs. The package mice implemented the MICE procedure within R.
All tests are 2-sided with p-values of 0.05 or less denoting statistical significance. Statistical analysis will be performed on R 3.5.1
| Study Type : | Observational |
| Actual Enrollment : | 212 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Prognostic Factors of Carbon Monoxide-induced Coma Treated by Hyperbaric Oxygen: a Retrospective Study |
| Actual Study Start Date : | May 1, 2019 |
| Actual Primary Completion Date : | June 30, 2019 |
| Actual Study Completion Date : | June 30, 2019 |
- Mortality rate [ Time Frame: 28-day ]Mortality rate during the stay in hospital: patient alive or not at discharge or death
- Cognitive sequelae at hospital discharge [ Time Frame: 28-day ]Assessment of neurological sequelae at hospital discharge: epilepsia or abnormal movements recorded in files
- Cognitive sequelae at hospital discharge [ Time Frame: 28-day ]Assessment of neurological sequelae at hospital discharge: motor deficit recorded in files
- Cognitive sequelae at hospital discharge [ Time Frame: 28-day ]Assessment of neurological sequelae at hospital discharge: disorders of consciousness recorded in files
- Cognitive sequelae at hospital discharge [ Time Frame: 28-day ]Assessment of neurological sequelae at hospital discharge: cognitive and psychological disorders recorded in files
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- All comatose patients (Glasgow coma score <8) due to carbon monoxide poisoning, treated by hyperbaric oxygen therapy in a tertiary hospital in Île de France area;
- Aged ≥ 18 years;
- Hospitalized in hyperbaric medicine unity of Raymond Poincaré hospital in Garches.
Exclusion Criteria:
- Pregnant woman;
- Patient present clinical signes of stroke and without CO detection.
In case of unusable data, patient will be excluded from study.
| France | |
| Intensive Care Unit, Raymond Poincaré hospital | |
| Garches, France, 92380 | |
| Principal Investigator: | Paris Meng, MD | Intensive Care Unit, Raymond Poincaré hospital | |
| Study Director: | Djillali ANNANE, MD, PhD | Intensive Care Unit, Raymond Poincaré hospital |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | April 15, 2019 | ||||||
| First Posted Date | April 24, 2019 | ||||||
| Last Update Posted Date | July 7, 2020 | ||||||
| Actual Study Start Date | May 1, 2019 | ||||||
| Actual Primary Completion Date | June 30, 2019 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
Mortality rate [ Time Frame: 28-day ] Mortality rate during the stay in hospital: patient alive or not at discharge or death
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| Original Primary Outcome Measures |
Mortality rate [ Time Frame: 28-day ] Mortality rate during ICU period: patient alive or not at discharge or death
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| Change History | |||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | Carbon Monoxide-induced Coma: Prognostic Factors | ||||||
| Official Title | Prognostic Factors of Carbon Monoxide-induced Coma Treated by Hyperbaric Oxygen: a Retrospective Study | ||||||
| Brief Summary | The primary objective of the study is to determine prognostic factors for hospital-mortality following carbon monoxide (CO)-induced coma. The secondary objective is to determine prognostic factors of CO related cognitive sequelae, at the time of hospital discharge. | ||||||
| Detailed Description |
Carbon monoxide is a leading cause of poison related lethality in France. Moreover, survivors may develop severe neuro-cognitive sequelae. Few studies sought to determine prognostic factors related to CO induced coma. Coma is defined as a Glasgow coma score of < 8. Neurological sequels will be considered persistent when present at hospital discharge. This is a retrospective observational study. All comatose patients with Glasgow coma score < 8 due to carbon monoxide poisoning, treated by hyperbaric oxygen therapy in a tertiary hospital in the Île de France area, will be included in the study. Clinical, biological, iconographic and electrophysiological data collected from patient's medical files between January 2000 to December 2018 will be analysed retrospectively. Statistics Base-line characteristics will be summarized using tabulated Statistics, namely median [interquartile range, IQR] or percentages (*"Statistics") unless specified. Exact Fisher tests will be used to compare distribution of binary outcomes, while nonparametric Wilcoxon rank sum tests will be used for comparison of continuous variables. Logistic regression models will be used to measure the strength of association of the variables with the outcomes, by odds ratio (OR), either unadjusted or adjusted in multivariable models. Multivariate imputation by chained equations (MICE) will be used as the method of dealing with missing data in covariates. It operates under the assumption that given the variables used in the imputation procedure, the missing data are Missing At Random (MAR), which means that the probability that a value is missing depends only on observed values and not on unobserved values. A total of m = 30 imputed datasets will be generated, with Rubin's rules applied thereafter to provide mean estimates of the ORs. The package mice implemented the MICE procedure within R. All tests are 2-sided with p-values of 0.05 or less denoting statistical significance. Statistical analysis will be performed on R 3.5.1 |
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| Study Type | Observational | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Probability Sample | ||||||
| Study Population | All comatose patients (Glasgow coma score <8) due to carbon monoxide poisoning, treated by hyperbaric oxygen therapy in a tertiary hospital in the greater Paris area were included in the current study | ||||||
| Condition |
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| Intervention | Not Provided | ||||||
| Study Groups/Cohorts | Not Provided | ||||||
| Publications * | Resche-Rigon M, White IR. Multiple imputation by chained equations for systematically and sporadically missing multilevel data. Stat Methods Med Res. 2018 Jun;27(6):1634-1649. doi: 10.1177/0962280216666564. Epub 2016 Sep 19. | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Completed | ||||||
| Actual Enrollment |
212 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Actual Study Completion Date | June 30, 2019 | ||||||
| Actual Primary Completion Date | June 30, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
In case of unusable data, patient will be excluded from study. |
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries | France | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03926494 | ||||||
| Other Study ID Numbers | 18PMG-COMA-CO | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Assistance Publique - Hôpitaux de Paris | ||||||
| Study Sponsor | Assistance Publique - Hôpitaux de Paris | ||||||
| Collaborators | Not Provided | ||||||
| Investigators |
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| PRS Account | Assistance Publique - Hôpitaux de Paris | ||||||
| Verification Date | November 2019 | ||||||
