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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

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

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
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Coma




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



Information from the National Library of Medicine

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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.


Information from the National Library of Medicine

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


Locations
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France
Intensive Care Unit, Raymond Poincaré hospital
Garches, France, 92380
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Paris Meng, MD Intensive Care Unit, Raymond Poincaré hospital
Study Director: Djillali ANNANE, MD, PhD Intensive Care Unit, Raymond Poincaré hospital
Additional Information:
Publications:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03926494    
Other Study ID Numbers: 18PMG-COMA-CO
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Carbon monoxide poisoning
Oxygen
Coma
Hyperbaric oxygen
Additional relevant MeSH terms:
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Coma
Poisoning
Carbon Monoxide Poisoning
Chemically-Induced Disorders
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Gas Poisoning