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NCT03834246 Clinical Trial

Smoke Inhalation Injury in Patients Admitted to Intensive Care

Morality Clinical Trial

— fumeintox  

Official title:
Prognostic Factors for Smoke Inhalation Injury in Patients Admitted to Intensive Care

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03834246
Other study ID # Cicit805
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 16, 2018
Est. completion date May 31, 2020

Study information
Verified date November 2018
Source Centre d'Investigation Clinique et Technologique 805
Contact Rania BOUNAB, Dr
Phone +33 (1) 74 10 7778
Email rania.bounab@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 700
Est. completion date May 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Raymond Poincaré Garches

Sponsors (1)
Lead Sponsor Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

References & Publications (5)

Darling GE, Keresteci MA, Ibañez D, Pugash RA, Peters WJ, Neligan PC. Pulmonary complications in inhalation injuries with associated cutaneous burn. J Trauma. 1996 Jan;40(1):83-9. — View Citation

Kim Y, Kym D, Hur J, Yoon J, Yim H, Cho YS, Chun W. Does inhalation injury predict mortality in burns patients or require redefinition? PLoS One. 2017 Sep 27;12(9):e0185195. doi: 10.1371/journal.pone.0185195. eCollection 2017. — View Citation

Liao WC, Cheng WC, Wu BR, Chen WC, Chen CY, Chen CH, Tu CY, Hsia TC. Outcome and prognostic factors of patients treated in the intensive care unit for carbon monoxide poisoning. J Formos Med Assoc. 2018 Oct 5. pii: S0929-6646(17)30386-8. doi: 10.1016/j.jfma.2018.09.005. [Epub ahead of print] — View Citation

Raphael JC, Annane D, Chevret S. Hyperbaric oxygen for acute carbon monoxide poisoning. N Engl J Med. 2003 Feb 6;348(6):557-60; author reply 557-60. — View Citation

You K, Yang HT, Kym D, Yoon J, HaejunYim, Cho YS, Hur J, Chun W, Kim JH. Inhalation injury in burn patients: establishing the link between diagnosis and prognosis. Burns. 2014 Dec;40(8):1470-5. doi: 10.1016/j.burns.2014.09.015. Epub 2014 Oct 16. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary mortality rate survival study for the search of prognostic factors 20 years
Secondary epidemiologic characteritics description of quantitative and qualitative data 20 years
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