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

Not Applicable

Completed

• Conditions: Intubation
• Interventions: Device: Airway Scope; Device: Macintosh Laryngoscope

• Registration Number: NCT00980590
• Lead Sponsor: The Cleveland Clinic

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.

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 Timeline

• Study Start: 2008-09
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Study First Submitted: 2009-09-18
• Study First Submitted QC: 2009-09-18
• Study First Posted: 2009-09-21
• Status Verified: 2016-12
• Results First Submitted: 2016-12-12
• Results First Submitted QC: 2016-12-12
• Results First Posted: 2017-02-06
• Last Update Submitted: 2023-06-15
• Last Update Posted: 2023-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Airway Scope	Airway Scope	Intubation with Airway Scope
Macintosh laryngoscope	Macintosh Laryngoscope	Intubation with Macintosh laryngoscope

Primary Outcome Measures

Name	Time	Method
Intubation Time	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

Name	Time	Method
Number of Intubation Attempts	Intubation period
Overall Intubation Success Rate	Intubation period
Incidence of Intubation Complications	Intubation period	Including mucosal trauma, dental injury, lip injury, hypoxia (SPO2\<95%) and Esophageal intubation

Trial Locations

Locations (1)

Kosei Hospital,.; 🇯🇵 Tokyo, Japan