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| ID | Type | Description | Link |
|---|---|---|---|
| H-A-2009-022 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional flexible videoscope for intubation | Active Comparator |
| |
| Single-patient flexible endoscope | Experimental | Single-patient flexible video-endoscope used for tracheal intubation in this intervention-arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tracheal intubation with a single use flexible videoscope | Procedure | tracheal intubation with a single use flexible videoscope |
|
| 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 |
| 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 |
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Inclusion Criteria:
Study part 1:
Study part 2:
Exclusion Criteria:
Study part 1:
Study part 2:
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| Name | Affiliation | Role |
|---|---|---|
| Michael S Kristensen, MD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071 | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
| D008919 | Investigative Techniques |
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| 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 |