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Smoke Inhalation Injury in Patients Admitted to Intensive Care (fumeintox)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03834246
Recruitment Status : Recruiting
First Posted : February 7, 2019
Last Update Posted : February 7, 2019
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805

Brief Summary:

Many Studies have shown that the smoke-inhalation injury is responsible for a high mortality mainly related to the systemic effects of carbon monoxide and cyanide. Respiratory lesions induced by smoke inhalation, is one of predictive factors of mortality.

The aim of the study is to identify the clinical and epidemiological characteristics of smoke-inhalation injury and to identify prognostic factors among these patients .

Condition or disease
Smoke Inhalation Injury Morality

Detailed Description:

The study is a monocentric, retrospective, descriptive and analytical study , betwen december 1997 and september 2018 in intensive care unit of university of hospital.

All patients aged over 18 year and who had received a diagnosis of smoke- inhalation injury and were admitted to the ICU of Medical University Hospital , a referral center in Paris providing HBO therapy , were potentially eligible for inclusion in this investigation.

Criteria used for recommending HBO therapy to a patient with transient or prolonged unconsciousness, abnormal neurologic findings on physical examination.

Data were analyzed to identify independent factors that may influence mortality.

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prognostic Factors for Smoke Inhalation Injury in Patients Admitted to Intensive Care
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : May 31, 2020

Primary Outcome Measures :
  1. mortality rate [ Time Frame: 20 years ]
    survival study for the search of prognostic factors

Secondary Outcome Measures :
  1. epidemiologic characteritics [ Time Frame: 20 years ]
    description of quantitative and qualitative data

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:   Non-Probability Sample
Study Population
We performed a retrospective study of patients admitted to a university affiliated hospital ICU between December 1997 and september 2018 following smoke -inhalation poisoning. Outcomes were survival to ICU discharge .

Inclusion Criteria

  • Men or women over the age of 18
  • Hyperbaric oxygen therapy between 1997 and 2018

Exclusion Criteria

  • Patients under 18 years old.
  • Patient opposed to the use of his data
  • Patients not treated with hyperbaric oxygen

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 identifier (NCT number): NCT03834246

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Contact: Rania BOUNAB, Dr +33 (1) 74 10 7778
Contact: Fatima IZEDAREN, CRA +33 (1) 47 10 44 49

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Raymond Poincaré Recruiting
Garches, France, 92380
Contact: Rania BOUNAB    0698258796   
Contact: rania Bounab    0147107778   
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
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Principal Investigator: Rania BOUNAB, dr Raymond Poincaré Hospital

Additional Information:
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Responsible Party: Centre d'Investigation Clinique et Technologique 805 Identifier: NCT03834246     History of Changes
Other Study ID Numbers: Cicit805
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: November 2018

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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 Centre d'Investigation Clinique et Technologique 805:
Prognostic Factors
intensive care unit

Additional relevant MeSH terms:
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Wounds and Injuries
Respiratory Aspiration
Smoke Inhalation Injury
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Burns, Inhalation