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Carbon Monoxide-induced Coma: Prognostic Factors (Coma-CO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03926494
Recruitment Status : Completed
First Posted : April 24, 2019
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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
 (submitted: July 1, 2020)
Mortality rate [ Time Frame: 28-day ]
Mortality rate during the stay in hospital: patient alive or not at discharge or death
Original Primary Outcome Measures
 (submitted: April 23, 2019)
Mortality rate [ Time Frame: 28-day ]
Mortality rate during ICU period: patient alive or not at discharge or death
Change History
Current Secondary Outcome Measures
 (submitted: July 1, 2020)
  • 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
Original Secondary Outcome Measures
 (submitted: April 23, 2019)
  • Cognitive sequelae at ICU discharge [ Time Frame: 28-day ]
    Assessment of neurological sequelae at ICU discharge: epilepsia or abnormal movements recorded in files
  • Cognitive sequelae at ICU discharge [ Time Frame: 28-day ]
    Assessment of neurological sequelae at ICU discharge: motor deficit recorded in files
  • Cognitive sequelae at ICU discharge [ Time Frame: 28-day ]
    Assessment of neurological sequelae at ICU discharge: disorders of consciousness recorded in files
  • Cognitive sequelae at ICU discharge [ Time Frame: 28-day ]
    Assessment of neurological sequelae at ICU discharge: cognitive and psychological disorders recorded in files
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

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
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
  • Coma
  • Carbon Monoxide Poisoning
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 23, 2019)
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:

  • 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.

Sex/Gender
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: Paris Meng, MD Intensive Care Unit, Raymond Poincaré hospital
Study Director: Djillali ANNANE, MD, PhD Intensive Care Unit, Raymond Poincaré hospital
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date November 2019