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Airway Scope and Macintosh Laryngoscope for Tracheal Intubation in Patients Lying on the Ground

This study has been completed.
Sponsor:
Collaborators:
Kosei Hospital, Tokyo, Japan.
Tokyo Women's Medical University, Tokyo, Japan.
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00980590
First received: September 18, 2009
Last updated: November 23, 2011
Last verified: September 2009
  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

Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • 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
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00980590

Locations
Japan
Kosei Hospital,.
Tokyo, Japan, 164-8617
Sponsors and Collaborators
Outcomes Research Consortium
Kosei Hospital, Tokyo, Japan.
Tokyo Women's Medical University, Tokyo, Japan.
Investigators
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 November 25, 2014