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Status unknownNCT03834246fumeintoxUpdated Feb 7, 2019

Smoke Inhalation Injury in Patients Admitted to Intensive Care

An observational study in Smoke Inhalation Injury and Morality, sponsored by Centre d'Investigation Clinique et Technologique 805. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-07.

Sponsored by Centre d'Investigation Clinique et Technologique 805 · Observational

The sponsor has not verified this record recently (last verified Nov 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
700
Ages
18 Years and older
Sex
All
01

Study 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 .

Read the 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.

02

Conditions studied

  • Smoke Inhalation Injury
  • Morality

Keywords

  • Prognostic Factors
  • intensive care unit
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In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's planned enrollment of 700 is above the median of 65 across 184 observational studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Centre d'Investigation Clinique et Technologique 805 is the lead sponsor of 74 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
700 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. mortality rate

    survival study for the search of prognostic factors

    Time frame: 20 years

Secondary outcomes

  1. epidemiologic characteritics

    description of quantitative and qualitative data

    Time frame: 20 years

07

Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 25406889 ↗
  • 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. PubMed 28953914 ↗
  • Darling GE, Keresteci MA, Ibanez D, Pugash RA, Peters WJ, Neligan PC. Pulmonary complications in inhalation injuries with associated cutaneous burn. J Trauma. 1996 Jan;40(1):83-9. doi: 10.1097/00005373-199601000-00016. PubMed 8577005 ↗
  • 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. 2019 Apr;118(4):821-827. doi: 10.1016/j.jfma.2018.09.005. Epub 2018 Oct 5. PubMed 30293927 ↗
  • 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. No abstract available. PubMed 12572578 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03834246
Lead sponsor
Centre d'Investigation Clinique et Technologique 805
Responsible party
Sponsor
First posted
Feb 7, 2019
Start date
Oct 16, 2018
Primary completion
Dec 31, 2019 (estimated)
Completion
May 31, 2020 (estimated)
Last update
Feb 7, 2019

Study contacts

Rania BOUNAB, Dr
Contact
rania.bounab@aphp.fr
+33 (1) 74 10 7778
Fatima IZEDAREN, CRA
Contact
fatima.izedaren@aphp.fr
+33 (1) 47 10 44 49
Rania BOUNAB, dr
principal investigator · Raymond Poincaré Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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