Evaluation of the Single Use Flexible Optical Scope Versus Multiple Use Flexible Optical Scopes for Intubation
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
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 25, 2010
CompletedFirst Posted
Study publicly available on registry
April 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedAugust 24, 2011
March 1, 2010
1.2 years
March 25, 2010
August 23, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
time for completion of intubation
This, the time for intubation, is measured immediately during the intubation, on the day that the specific patient participates in the study
September 2010
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
Conventional flexible videoscope for intubation
ACTIVE COMPARATORSingle-patient flexible endoscope
EXPERIMENTALSingle-patient flexible video-endoscope used for tracheal intubation in this intervention-arm
Interventions
tracheal intubation with a single use flexible videoscope
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071
Copenhagen, 2100, Denmark
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael S Kristensen, MD
Rigshospitalet, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
March 25, 2010
First Posted
April 9, 2010
Study Start
October 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
August 24, 2011
Record last verified: 2010-03