Evaluation of the Single Use Flexible Optical Scope Versus Multiple Use Flexible Optical Scopes for Intubation
NCT ID: NCT01100957
Last Updated: 2011-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2009-10-31
2010-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional flexible videoscope for intubation
tracheal intubation with a single use flexible videoscope
tracheal intubation with a single use flexible videoscope
Single-patient flexible endoscope
Single-patient flexible video-endoscope used for tracheal intubation in this intervention-arm
tracheal intubation with a single use flexible videoscope
tracheal intubation with a single use flexible videoscope
Interventions
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tracheal intubation with a single use flexible videoscope
tracheal intubation with a single use flexible videoscope
Eligibility Criteria
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Inclusion Criteria
* Patients scheduled for tracheal intubation and predicted to have a normal airway
* ASA class I, II or III
* \>18 years
2. 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
* Massive bleeding from the mouth
* Previously abandoned flexible optical intubation
2. Study part 2:
* Massive bleeding from the mouth
* Previously abandoned flexible optical intubation
* Patients with audible stridor
* Patients with dyspnea
18 Years
80 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Michael Seltz Kristensen
M.D.
Principal Investigators
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Michael S Kristensen, MD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071
Copenhagen, , Denmark
Countries
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Other Identifiers
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H-A-2009-022
Identifier Type: -
Identifier Source: secondary_id
aScope-1+2 a
Identifier Type: -
Identifier Source: org_study_id
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