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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00980590
First received: September 18, 2009
Last updated: December 12, 2016
Last verified: December 2016
  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
Device: Macintosh Laryngoscope

Study Type: Interventional
Study Design: Allocation: Randomized
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 The Cleveland Clinic:

Primary Outcome Measures:
  • Intubation Time [ Time Frame: The time from picking up the Airway Scope or Macintosh laryngoscope to confirmation of tracheal intubation by capnography. ]
    For the case with number of intubation attempt no more than 3, intubation time was defined as the total time of individual intubation attempt. Otherwise, intubation was defined as a failure and excluded from the calculation of intubation time.


Secondary Outcome Measures:
  • Overall Intubation Success Rate [ Time Frame: Intubation period ]
  • Number of Intubation Attempts [ Time Frame: Intubation period ]
  • Incidence of Intubation Complications [ Time Frame: Intubation period ]
    Including mucosal trauma, dental injury, lip injury, hypoxia (SPO2<95%) and Esophageal intubation


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
Experimental: Airway Scope
Intubation with Airway Scope
Device: Airway Scope
Tracheal intubation by Airway Scope
Active Comparator: Macintosh laryngoscope
Intubation with Macintosh laryngoscope
Device: Macintosh Laryngoscope
Tracheal intubation by Macintosh Laryngoscope

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 and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for various surgeries requiring tracheal intubation as part of anesthesia and designated as 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
The Cleveland Clinic
Investigators
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
Principal Investigator: Ryu Komatsu, M.D. Kosei Hospital, Tokyo, Japan.
  More Information

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00980590     History of Changes
Other Study ID Numbers: 44-012
Study First Received: September 18, 2009
Results First Received: December 12, 2016
Last Updated: December 12, 2016

Keywords provided by The Cleveland Clinic:
supine emergency intubations
emergency intubations

ClinicalTrials.gov processed this record on March 30, 2017