Carbon Monoxide-induced Coma: Prognostic Factors

NCT03926494 | Completed

• 1 other identifier: 18PMG-COMA-CO
• Study Type: observational
• Target: 212
• Locations: 1 country
• Sites: 1

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.

Conditions

Coma; Carbon Monoxide Poisoning

Keywords

Carbon monoxide poisoning; Oxygen; Coma; Hyperbaric oxygen

Outcome Measures

Primary Outcomes (1)

• Mortality rate

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

  28-day

Secondary Outcomes (4)

• Cognitive sequelae at hospital discharge

  28-day

• Cognitive sequelae at hospital discharge

  28-day

• Cognitive sequelae at hospital discharge

  28-day

• Cognitive sequelae at hospital discharge

  28-day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Pregnant woman;
• Patient present clinical signes of stroke and without CO detection.
• In case of unusable data, patient will be excluded from study.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Intensive Care Unit, Raymond Poincaré hospital

Garches, 92380, France

Location

Related Publications (1)

• 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.

  PMID: 27647809 BACKGROUND

Related Links

• Mice : Multivariate Imputation by Chained Equations in R.
• R Development Core Team (2008). R: A language and environment for statistical computing. R Foundation for Statistical Computing
• R Development Core Team (2008)

MeSH Terms

Conditions

Coma; Carbon Monoxide Poisoning

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gas Poisoning; Poisoning; Chemically-Induced Disorders

Study Officials

• Paris Meng, MD

  Intensive Care Unit, Raymond Poincaré hospital

  PRINCIPAL INVESTIGATOR

• Djillali ANNANE, MD, PhD

  Intensive Care Unit, Raymond Poincaré hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 24, 2019
• Study Start: May 1, 2019
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 7, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)