NCT01100957CompletedNot Applicable
Evaluation and Comparison of the New Single Use Ambu aScope With Olympus BF 160 Multiple Use Scope for Securing the Airway of the Anaesthetised/Awake Patients' Normal or Difficult Airway
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- time for completion of intubation
Study Overview
Brief Summary
The study is in two parts
Part one of the study describes the use of the new single-use flexible video-scope for intubation of patients with predicted normal airways.
Part two compares the performance of the single-use flexible video-scope with that of a conventional flexible video-scope for awake intubation of patients with predicted difficult airways.
The hypothesis is that the new single-use flexible video-scope for intubation performs as well as the traditional scope.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Study part 1:
- •Patients scheduled for tracheal intubation and predicted to have a normal airway
- •ASA class I, II or III
- •>18 years
- •Study part 2:
- •Adult patients scheduled for tracheal intubation and predicted to have a difficult airway
- •ASA class I, II or III
- •>18 years
Exclusion Criteria
- •Study part 1:
- •Massive bleeding from the mouth
- •Previously abandoned flexible optical intubation
- •Study part 2:
- •Massive bleeding from the mouth
- •Previously abandoned flexible optical intubation
- •Patients with audible stridor
- •Patients with dyspnea
Outcomes
Primary Outcomes
time for completion of intubation
Time Frame: September 2010
This, the time for intubation, is measured immediately during the intubation, on the day that the specific patient participates in the study
Secondary Outcomes
- time for preparing and cleaning the endoscopes(september 2010)
- number of intubation attempts(september 2010)
- success rate of endotracheal intubation(september 2010)
- total time for the intubation-procedure inclusive the time for distributing local analgesics(september 2010)
- Quality of the image from the videoscope(september 2010)
- Evaluation of the insertion cord of the flexible scope(september 2010)
- Evaluation of the working-/-injection-channel(september 2010)
Investigators
Michael Seltz Kristensen
M.D.
Rigshospitalet, Denmark
Study Sites (2)
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