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

NCT ID: NCT00980590

Last Updated: 2023-06-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Airway Scope

Intubation with Airway Scope

Group Type EXPERIMENTAL

Airway Scope

Intervention Type DEVICE

Tracheal intubation by Airway Scope

Macintosh laryngoscope

Intubation with Macintosh laryngoscope

Group Type ACTIVE_COMPARATOR

Macintosh Laryngoscope

Intervention Type DEVICE

Tracheal intubation by Macintosh Laryngoscope

Interventions

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Airway Scope

Tracheal intubation by Airway Scope

Intervention Type DEVICE

Macintosh Laryngoscope

Tracheal intubation by Macintosh Laryngoscope

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel I Sessler, MD

Role: STUDY_CHAIR

The Cleveland Clinic

Ryu Komatsu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Kosei Hospital, Tokyo, Japan.

Locations

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Kosei Hospital,.

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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44-012

Identifier Type: -

Identifier Source: org_study_id

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