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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

Carbon Monoxide-induced Coma: Prognostic Factors

Clinicaltrials.gov identifier NCT03926494

Recruitment Status Completed

First Posted April 24, 2019

Last update posted July 7, 2020

Study Description

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.

  • Condition or Disease:Coma
    Carbon Monoxide Poisoning
  • Intervention/Treatment:
  • Phase: N/A
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

Study Design
  • 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 2019
  • Actual Primary Completion Date: June 2019
  • Actual Study Completion Date: June 2019
Outcome Measures
  • Primary Outcome Measures: 1. Mortality rate [ Time Frame: 28-day ]
    Mortality rate during the stay in hospital: patient alive or not at discharge or death
  • Secondary Outcome Measures: 1. Cognitive sequelae at hospital discharge [ Time Frame: 28-day ]
    Assessment of neurological sequelae at hospital discharge: epilepsia or abnormal movements recorded in files
  • 2. Cognitive sequelae at hospital discharge [ Time Frame: 28-day ]
    Assessment of neurological sequelae at hospital discharge: motor deficit recorded in files
  • 3. Cognitive sequelae at hospital discharge [ Time Frame: 28-day ]
    Assessment of neurological sequelae at hospital discharge: disorders of consciousness recorded in files
  • 4. Cognitive sequelae at hospital discharge [ Time Frame: 28-day ]
    Assessment of neurological sequelae at hospital discharge: cognitive and psychological disorders recorded in files
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • 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
Criteria

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.

Contacts and Locations
Contacts
Locations

France
Intensive Care Unit, Raymond Poincaré hospital
Garches

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: Paris Meng, MD Intensive Care Unit, Raymond Poincaré hospital

Study Director: Djillali ANNANE, MD, PhD Intensive Care Unit, Raymond Poincaré hospital

More Information