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NCT02576756 Clinical Trial

Retrospective Study in Patients Who Have Had a Difficult Intubation.

Pneumonia Clinical Trial

Official title:
Retrospective Study of the Risk of Aspiration and Postoperative Pulmonary Problems in Patients Who Have Had a Difficult Intubation.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02576756
Other study ID # PULINT
Secondary ID
Status Completed
Phase N/A
First received October 13, 2015
Last updated August 16, 2016
Start date October 2015
Est. completion date June 2016

Study information
Verified date August 2016
Source Universitair Ziekenhuis Brussel
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicines and Health Products, FAMHP
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel

Outcome
Type Measure Description Time frame Safety issue
Primary Relative risk for postoperative pulmonary incidents number of participants with Relative risk 6 months No
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