Airway Scope and Macintosh Laryngoscope for Tracheal Intubation in Patients Lying on the Ground
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Purpose
Pre-hospital intubation is often required in sub-optimal conditions, such as in patients lying on the ground. Direct laryngoscopy and intubation of a patient lying supine on the ground is difficult because the intubator's head is far above the head of the patient. It is thus tricky to align the intubator's visual axis with the patient's tracheal axis. The Airway Scope is a new laryngoscope designed to facilitate intubation without requiring alignment of the oral, pharyngeal, and tracheal axes. We thus tested the hypothesis that the intubation with the Airway Scope is faster than the Macintosh laryngoscope in subjects lying on the ground.
| Condition | Intervention |
|---|---|
|
Intubation |
Device: Airway scope intubation tube |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care |
| Official Title: | Airway Scope and Macintosh Laryngoscope for Tracheal Intubation in Patients Lying on the Ground |
- The primary outcome measure of the study was the difference in intubation times between the Airway Scope and the Macintosh laryngoscope [ Time Frame: time to intubate ] [ Designated as safety issue: No ]
| Enrollment: | 100 |
| Study Start Date: | September 2008 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Airway Scope
Intubation with Airway Scope
|
Device: Airway scope intubation tube
comparison of intubation speed
|
|
Active Comparator: Macintosh laryngoscope
intubation with Macintosh laryngoscope
|
Device: Airway scope intubation tube
comparison of intubation speed
|
Detailed Description:
Adult surgical patients were enrolled. Following anesthesia induction and muscle relaxation, direct laryngoscopy was performed as usual and airway characteristics noted. Patients were randomly assigned to tracheal intubation by either the Airway Scope (n=50) or the Macintosh laryngoscope (n=50). Intubation was performed from a table positioned at the height as the operating table, thus simulating intubating on the ground. Overall intubation success rate, time required for intubation, the number of attempts required for successful intubation, and airway complications related to intubation were recorded.
Eligibility| Ages Eligible for Study: | 18 Years to 91 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients scheduled for various elective surgeries and were designated American Society of Anesthesiologists (ASA) physical status I, II, or III.
Exclusion Criteria:
- Patients with an increased risk of pulmonary aspiration, cervical spine pathology, anticipated airway difficulties (i.e., Mallampati grade IV or thyromental distance <6 cm), and American Society of Anesthesiologists physical status >III.
Contacts and Locations| Japan | |
| Kosei Hospital,. | |
| Tokyo, Japan, 164-8617 | |
| Study Chair: | Daniel I Sessler, MD | The Cleveland Clinic |
| Principal Investigator: | Ryu Komatsu, M.D. | Kosei Hospital, Tokyo, Japan. |
More Information
No publications provided
| Responsible Party: | Ryu Komatsu, M.D., Kosei Hospital, Tokyo, Japan. |
| ClinicalTrials.gov Identifier: | NCT00980590 History of Changes |
| Other Study ID Numbers: | 44-012 |
| Study First Received: | September 18, 2009 |
| Last Updated: | November 23, 2011 |
| Health Authority: | Japan: Institutional Review Board |
Keywords provided by Outcomes Research Consortium:
|
supine emergency intubations emergency intubations |
ClinicalTrials.gov processed this record on May 23, 2013