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

NCT00980590 | Completed Results

• 1 other identifier: 44-012
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intubation

Keywords

supine emergency intubations; emergency intubations

Outcome Measures

Primary Outcomes (1)

• Intubation Time

  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 Outcomes (3)

• Overall Intubation Success Rate

  Intubation period

• Number of Intubation Attempts

  Intubation period

• Incidence of Intubation Complications

  Intubation period

Study Arms (2)

Airway Scope

EXPERIMENTAL

Intubation with Airway Scope

Device: Airway Scope

Macintosh laryngoscope

ACTIVE COMPARATOR

Intubation with Macintosh laryngoscope

Device: Macintosh Laryngoscope

Interventions

Airway Scope DEVICE

Tracheal intubation by Airway Scope

Airway Scope

Macintosh Laryngoscope DEVICE

Tracheal intubation by Macintosh Laryngoscope

Macintosh laryngoscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Kosei Hospital,.

Tokyo, 164-8617, Japan

Location

Limitations and Caveats

Patients with anticipated airway difficulties were excluded. All intubations were performed by a single investigator.

Results Point of Contact

• Title: Dr. Daniel Sessler
• Organization: Cleveland Clinic

sessled@ccf.org

216-445-6500

Study Officials

• Daniel I Sessler, MD

  The Cleveland Clinic

  STUDY CHAIR

• Ryu Komatsu, M.D.

  Kosei Hospital, Tokyo, Japan.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2009
• First Posted: September 21, 2009
• Study Start: September 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: June 29, 2023
• Results First Posted: February 6, 2017

Record last verified: 2016-12

Locations

JP (1)