Clincosm LogoSign in Get a demo

Retrospective Study in Patients Who Have Had a Difficult Intubation.

Sponsor
Universitair Ziekenhuis Brussel (Other)
Overall Status
Completed
CT.gov ID
NCT02576756
Collaborator
(none)
1,000
Enrollment
8
Duration (Months)

Study Details

Study Description

Brief Summary

The investigator wants to investigate if there is an increased risk of postoperative pulmonary problems in patients who have had an intubation where there was need for more than a laryngoscope.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A difficult intubation is defined as an intubation in which more than a laryngoscope was needed.

    Afterwards patient data retrieved from the Clinical Work Station: age, type of operation and time, date, type of anaesthesia, de tools needed for intubation, time needed for intubation and anaesthesia.

    In the Clinical Work Station of the Hospital the investigator will search for the following data in these selected patients: preoperative comorbidities, home medication, type of postoperative pulmonary problems and the treatment that was given, time of hospital stay and which department the patient stayed.

    Patients with a difficult intubation will be linked to a patient with a corresponding medical history and type of operation but without a difficult intubation. The investigator will look for the same parameters of these patients in the Clinical Work Station.

    By means of an odds-ratio the relative risk of a pulmonary complication after a difficult intubation in connection with an easy intubation with different variables can be calculated.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Retrospective Study of the Risk of Aspiration and Postoperative Pulmonary Problems in Patients Who Have Had a Difficult Intubation.
    Study Start Date :
    Oct 1, 2015
    Actual Primary Completion Date :
    Jun 1, 2016
    Actual Study Completion Date :
    Jun 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    with difficult intubation

    Control population
    without difficult intubation

    Control population

    Outcome Measures

    Primary Outcome Measures

    1. Relative risk for postoperative pulmonary incidents [6 months]

      number of participants with Relative risk

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Every patient who had an intubation where another device than a laryngoscope was necessary
    Exclusion Criteria:
    • N/A

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Universitair Ziekenhuis Brussel

    Investigators

    • Principal Investigator: Josia B Glissenaar, Med student, Universitair Ziekenhuis Brussel
    • Study Chair: Jan Poelaert, PhD MED, Universitair Ziekenhuis Brussel

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Veerle Van Mossevelde, Data Nurse, Universitair Ziekenhuis Brussel
    ClinicalTrials.gov Identifier:
    NCT02576756
    Other Study ID Numbers:
    • PULINT
    First Posted:
    Oct 15, 2015
    Last Update Posted:
    Aug 17, 2016
    Last Verified:
    Aug 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Veerle Van Mossevelde, Data Nurse, Universitair Ziekenhuis Brussel
    Risk on aspiration
    Postoperative
    Difficult Intubation
    Additional relevant MeSH terms:
    Pneumonia

    Study Results

    No Results Posted as of Aug 17, 2016