Carbon Monoxide-induced Coma: Prognostic Factors (Coma-CO)
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|ClinicalTrials.gov Identifier: NCT03926494|
Recruitment Status : Completed
First Posted : April 24, 2019
Last Update Posted : July 7, 2020
|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.
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|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926494
|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|