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Retrospective Study in Patients Who Have Had a Difficult Intubation.

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

Tracking Information
First Submitted Date October 13, 2015
First Posted Date October 15, 2015
Last Update Posted Date August 17, 2016
Study Start Date October 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 15, 2015)
Relative risk for postoperative pulmonary incidents [ Time Frame: 6 months ]
number of participants with Relative risk
Original Primary Outcome Measures
 (submitted: October 13, 2015)
Relative risk for postoperative pulmonary incidents [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Retrospective Study in Patients Who Have Had a Difficult Intubation.
Official Title Retrospective Study of the Risk of Aspiration and Postoperative Pulmonary Problems in Patients Who Have Had a Difficult Intubation.
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.
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 Type Observational
Study Design Observational Model: Case Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Every patients who had an intubation where another device than a laryngoscope was necessary
Condition
  • Aspiration
  • Pneumonia
Intervention Not Provided
Study Groups/Cohorts
  • with difficult intubation
    Control population
  • without difficult intubation
    Control population
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: October 13, 2015)
1000
Original Estimated Enrollment Same as current
Actual Study Completion Date June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02576756
Other Study ID Numbers PULINT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Veerle Van Mossevelde, Universitair Ziekenhuis Brussel
Study Sponsor Universitair Ziekenhuis Brussel
Collaborators Not Provided
Investigators
Principal Investigator: Josia B Glissenaar, Med student Universitair Ziekenhuis Brussel
Study Chair: Jan Poelaert, PhD MED Universitair Ziekenhuis Brussel
PRS Account Universitair Ziekenhuis Brussel
Verification Date August 2016