Home › NCT05989880

Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)

Pilot Feasibility Trial of the SafeLM Supraglottic Airway

Who can join

Ages 18 and older · All sexes

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)

About the study

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

What is being tested

• 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 an endotracheal tube with video capability (device)
• SafeLM as a conduit for intubation using a bougie with video capability (device)

Sponsor: The University of Texas Health Science Center, Houston · Participants: 60 · Started: Sep 19, 2023

Contact the study team

• Lauren M Nakazawa, MD · Phone: 713-500-6775
• Carlos Artime, MD · Phone: 713-500-6171

Official record on ClinicalTrials.gov — NCT05989880

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.