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Retrospective Study in Patients Who Have Had a Difficult Intubation.

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. Identifier: NCT02576756
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : August 17, 2016
Information provided by (Responsible Party):
Veerle Van Mossevelde, Universitair Ziekenhuis Brussel

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
Aspiration Pneumonia

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.

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Study Type : Observational
Estimated 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 : October 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

with difficult intubation
Control population
without difficult intubation
Control population

Primary Outcome Measures :
  1. Relative risk for postoperative pulmonary incidents [ Time Frame: 6 months ]
    number of participants with Relative risk

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Every patients who had an intubation where another device than a laryngoscope was necessary

Inclusion Criteria:

  • Every patient who had an intubation where another device than a laryngoscope was necessary

Exclusion Criteria:

  • N/A

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 identifier (NCT number): NCT02576756

Sponsors and Collaborators
Universitair Ziekenhuis Brussel
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Principal Investigator: Josia B Glissenaar, Med student Universitair Ziekenhuis Brussel
Study Chair: Jan Poelaert, PhD MED Universitair Ziekenhuis Brussel
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Responsible Party: Veerle Van Mossevelde, Data Nurse, Universitair Ziekenhuis Brussel Identifier: NCT02576756    
Other Study ID Numbers: PULINT
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Veerle Van Mossevelde, Universitair Ziekenhuis Brussel:
Risk on aspiration
Difficult Intubation
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections