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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03204656
Other study ID # 2016-A02070-51
Secondary ID
Status Completed
Phase N/A
First received March 22, 2017
Last updated June 28, 2017
Start date February 20, 2017
Est. completion date May 20, 2017

Study information

Verified date May 2017
Source Centre Chirurgical Marie Lannelongue
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Difficult orotracheal intubation carries a risk of hemodynamic collapse, neurological sequelae secondary to cerebral anoxia or death. Anesthetic scores and predictive indices are used to predict difficulties and avoid complications for usual tracheal intubation. However, existing indices are not adapted to selective bronchial intubations.

The aim of the study is to determine the incidence of unexpected difficult SBI using conventional screening tests. It is a prospective descriptive epidemiological monocentric study comparing two groups of patients (selective vs. non selective intubations).


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date May 20, 2017
Est. primary completion date May 20, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- For adult patients : age greater than or equal to 18 years

- Patients with thoracic, cardiac, vascular or plastic surgery

Exclusion Criteria:

- Intubations performed before admission to the operating room or catheterization room;

- Patient whose age is less than 18 years

- Traditional re-intubation at the end of the procedure after a selective lung IOT;

- Selective re-intubation in a patient previously intubated on arrival at the operating theater;

- IOT in other departments of the HML (intensive care, Pulmonary Postoperative Unit (UPOP), bronchoscopy, hospitalization services, Intensive Care Unit (ICU), etc.).

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Hôpital Marie Lannelongue Le Plessis Robinson

Sponsors (1)

Lead Sponsor Collaborator
Centre Chirurgical Marie Lannelongue

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of difficult selective bronchial intubation Rate (percentage) 1 day
Secondary Predictive factors of difficult selective bronchial intubation questionnaire 1 day