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

NeuroTherapia, Inc. logo

NeuroTherapia, Inc.

Status

Completed

Conditions

Intubation

Treatments

Device: Airway Scope
Device: Macintosh Laryngoscope

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

Airway Scope
Experimental group
Description:
Intubation with Airway Scope
Treatment:
Device: Airway Scope
Macintosh laryngoscope
Active Comparator group
Description:
Intubation with Macintosh laryngoscope
Treatment:
Device: Macintosh Laryngoscope

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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