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Selective Bronchial Intubation (SBI) (SBI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03204656
Recruitment Status : Completed
First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Chirurgical Marie Lannelongue

Brief 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).


Condition or disease
Selective Bronchial Tube

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Selective Bronchial Intubation (SBI) at Marie Lannelongue Hospital (HML) : Epidemiology of Expected and Unexpected Difficult Intubations.
Actual Study Start Date : February 20, 2017
Actual Primary Completion Date : May 20, 2017
Actual Study Completion Date : May 20, 2017



Primary Outcome Measures :
  1. Rate of difficult selective bronchial intubation [ Time Frame: 1 day ]
    Rate (percentage)


Secondary Outcome Measures :
  1. Predictive factors of difficult selective bronchial intubation [ Time Frame: 1 day ]
    questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adult patients with intubation during surgery in Marie Lannelongue's hospital
Criteria

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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03204656


Locations
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France
Hôpital Marie Lannelongue
Le Plessis Robinson, France, 92350
Sponsors and Collaborators
Centre Chirurgical Marie Lannelongue
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Responsible Party: Centre Chirurgical Marie Lannelongue
ClinicalTrials.gov Identifier: NCT03204656    
Other Study ID Numbers: 2016-A02070-51
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Chirurgical Marie Lannelongue:
difficult orotracheal intubation
selective lung intubation
unexpected difficult selective lung intubation