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Completed

NCT Number: NCT03926494

Carbon Monoxide-induced Coma: Prognostic Factors

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intensive Care Unit, Raymond Poincaré hospital

Garches, 92380, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Mortality rate

    Time frame: 28-day

    Mortality rate during the stay in hospital: patient alive or not at discharge or death

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Prognostic Factors of Carbon Monoxide-induced Coma Treated by Hyperbaric Oxygen: a Retrospective Study

Acronym: Coma-CO

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 24, 2019
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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