Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)

Not Applicable

Recruiting

• Conditions: Anesthesia
• Interventions: Device: SafeLM as a supraglottic airway device with video capability; Device: SafeLM as a supraglottic airway device without video capability; Device: SafeLM as a conduit for intubation using a bougie with video capability; Device: SafeLM as a conduit for intubation using an endotracheal tube with video capability

• Registration Number: NCT05989880
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

The purpose of this study is to assess the feasibility of SafeLM as a primary airway device and as a conduit for intubation with and without the use of a bougie

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-08-09
• Study First Posted: 2023-08-14
• Study Start: 2023-09-19
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-10-02
• Study Completion: 2025-12-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• elective surgery requiring general anesthesia and airway management using a supraglottic airway device or endotracheal intubation

Exclusion Criteria

• pregnancy
• known or suspected difficult airway management
• history of oropharyngeal or upper airway surgery
• known or suspected airway or respiratory pathology, such as significant obstructive sleep apnea or chronic obstructive pulmonary disease (COPD)
• BMI greater than 40 kg/m2
• unable to undergo intubation via the oral route
• known or suspected full stomach or other risk factors for aspiration
• contraindication for the use of neuromuscular blocking agents
• history of significant gastroesophageal reflux disease (GERD)
• Vulnerable populations (cognitively impaired persons, prisoners)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SafeLM as a supraglottic airway device with video capability	SafeLM as a supraglottic airway device with video capability	-
SafeLM as a supraglottic airway device without video capability	SafeLM as a supraglottic airway device without video capability	-
SafeLM as a conduit for intubation using a bougie with video capability	SafeLM as a conduit for intubation using a bougie with video capability	-
SafeLM as a conduit for intubation using an endotracheal tube with video capability	SafeLM as a conduit for intubation using an endotracheal tube with video capability	-

Primary Outcome Measures

Name	Time	Method
Intubation success rate	at the time of intubation	This is assessed by the ability of the SafeLM to achieve adequate oxygenation and ventilation via the respective procedure once the airway device is in place.

Secondary Outcome Measures

Name	Time	Method
Safety of the SafeLM as a conduit for intubation	at the time of intubation	This will be assessed by the number of adverse events such as esophageal intubation, bronchial intubation, and hypoxia during the intubation process.
Number of insertion attempts required to achieve effective oxygenation and ventilation	at the time of intubation
Subjective ease of insertion of the airway device	at the time of intubation
Safety of the SafeLM as an SGA	at the time of intubation	This will be assessed by the number of adverse events such as airway obstruction, aspiration, and hypoxia.
Time to insertion	at the time of intubation	This is measured by the time from opening the mouth to the time of end tidal CO2 on capnography

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States