Evaluation of the Single Use Flexible Optical Scope Versus Multiple Use Flexible Optical Scopes for Intubation

Study Overview
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Brief Summary
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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.

Official Title
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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
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Tracheal Intubation, Difficult Airway

Intervention / Treatment
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* Procedure: tracheal intubation with a single use flexible videoscope


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional flexible videoscope for intubation<br> | Procedure: tracheal intubation with a single use flexible videoscope<br>* tracheal intubation with a single use flexible videoscope<br>|
| Experimental: Single-patient flexible endoscope<br>Single-patient flexible video-endoscope used for tracheal intubation in this intervention-arm | Procedure: tracheal intubation with a single use flexible videoscope<br>* tracheal intubation with a single use flexible videoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time for preparing and cleaning the endoscopes | this is measured in the hour before and after the intubation | september 2010 | 
| number of intubation attempts | measured during the intubation | september 2010 | 
| success rate of endotracheal intubation | measured during the intubation | september 2010 | 
| total time for the intubation-procedure inclusive the time for distributing local analgesics | measured during the intubation | september 2010 | 
| Quality of the image from the videoscope | Observed immediately before, and during, the intubation | september 2010 | 
| Evaluation of the insertion cord of the flexible scope | measured during the intubation | september 2010 | 
| Evaluation of the working-/-injection-channel | measured during the intubation | september 2010 |