Selective Bronchial Intubation (SBI) (SBI)

Selective Bronchial Intubation (SBI) at Marie Lannelongue Hospital (HML) : Epidemiology of Expected and Unexpected Difficult Intubations.

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).

Study Overview

• Status: Completed
• Conditions: Selective Bronchial Tube

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• France
  • Le Plessis Robinson, France, 92350
    • Hopital Marie Lannelongue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adult patients with intubation during surgery in Marie Lannelongue's hospital

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of difficult selective bronchial intubation	Rate (percentage)	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive factors of difficult selective bronchial intubation	questionnaire	1 day

Collaborators and Investigators

• Sponsor: Centre Chirurgical Marie Lannelongue

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2017
• Primary Completion (Actual): May 20, 2017
• Study Completion (Actual): May 20, 2017

Study Registration Dates

• First Submitted: March 22, 2017
• First Submitted That Met QC Criteria: June 28, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: difficult orotracheal intubation; selective lung intubation; unexpected difficult selective lung intubation
• Other Study ID Numbers: 2016-A02070-51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No