Smoke Inhalation InjuryfumeintoxNCT03834246
Smoke Inhalation Injury in Patients Admitted to Intensive Care
An observational study of Smoke Inhalation Injury and Morality, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoke Inhalation Injury, Morality
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2018to 31 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 .
Who may be able to join
- Men or women over the age of 18
- Hyperbaric oxygen therapy between 1997 and 2018
Who cannot join
- Patients under 18 years old.
- Patient opposed to the use of his data
- Patients not treated with hyperbaric oxygen
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Raymond Poincaré
Garches, 92380
Rania BOUNAB, 0698258796, rania.bounab@aphp.fr
rania Bounab, 0147107778, rania.bounab@aphp.fr
About this study
Official title: Prognostic Factors for Smoke Inhalation Injury in Patients Admitted to Intensive Care
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.
- Conditions
- Smoke Inhalation Injury, Morality
- Keywords
- Prognostic Factors, intensive care unit
- Medical subject headings
- Smoke Inhalation Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate
survival study for the search of prognostic factors
Measured: 20 years
Secondary outcomes (1)
epidemiologic characteritics
description of quantitative and qualitative data
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start16 Oct 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Smoke Inhalation InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rania BOUNAB, dr, Principal investigator, Raymond Poincaré Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834246
- Sponsor's protocol ID
- Cicit805
- Acronym
- fumeintox
- Status last verified
- Nov 2018
- First submitted
- 21 Nov 2018
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 25406889Kim 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 28953914Darling 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 8577005Liao 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 30293927Raphael 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors for Smoke Inhalation Injury in Patients Admitted to Intensive Care
- ClinicalTrials.gov ID
- NCT03834246
- Acronym / sponsor ID
- fumeintox / Cicit805
- Conditions
- Smoke Inhalation Injury, Morality
- Keywords
- Prognostic Factors, intensive care unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 7 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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 .
Key inclusion criteria (2 listed)
- Men or women over the age of 18
- Hyperbaric oxygen therapy between 1997 and 2018
Key exclusion criteria (3 listed)
- Patients under 18 years old.
- Patient opposed to the use of his data
- Patients not treated with hyperbaric oxygen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mortality rate
Time frame: 20 years
survival study for the search of prognostic factors
1 secondary outcome
epidemiologic characteritics
Time frame: 20 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
- Background: PubMed 25406889You 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.
- Background: PubMed 28953914Kim 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.
- Background: PubMed 8577005Darling 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.
- Background: PubMed 30293927Liao 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.
- Background: PubMed 12572578Raphael 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rania BOUNAB, dr principal investigator
Raymond Poincaré Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoke Inhalation Injury and Morality, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rania BOUNAB, Dr (+33 (1) 74 10 7778, rania.bounab@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality rate (time frame: 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03834246, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2019.