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

June 15, 2023 updated by: The Cleveland Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 164-8617
        • Kosei Hospital,.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The time from picking up the Airway Scope or Macintosh laryngoscope to confirmation of tracheal intubation by capnography.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Ryu Komatsu, M.D., Kosei Hospital, Tokyo, Japan.
  • Study Chair: Daniel I Sessler, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

September 18, 2009

First Submitted That Met QC Criteria

September 18, 2009

First Posted (Estimated)

September 21, 2009

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 44-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intubation

Clinical Trials on Airway Scope

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe