Pilot Feasibility Trial of the SafeLM Supraglottic Airway

This study is testing a new device called SafeLM, which helps manage your airway during surgery. It can be used in a few ways: as a primary breathing tube with or without video guidance, or to help place another breathing tube (endotracheal tube) using video. The main goal is to see how well the SafeLM device works to successfully place a breathing tube. You might be able to join if you are 18 or older and having elective surgery that requires general anesthesia and airway management. You cannot participate if you are pregnant, have a known difficult airway, or certain other medical conditions. The study is currently enrolling about 60 participants.

Study design: This is a pilot study involving about 60 participants to test the SafeLM device in different ways during surgery.
What's involved: You would receive the SafeLM device as part of your airway management during an elective surgery requiring general anesthesia.
Compensation: Not stated in the trial record.
Follow-up: The main success measure (intubation success rate) is checked at the time of intubation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)

Recruiting

NAAges 18+InterventionalTreatment

The University of Texas Health Science Center, Houston

~60 participants

Updated 2024-12-10 on ClinicalTrials.gov

What's tested:SafeLM as a supraglottic airway device with video capabilitySafeLM as a supraglottic airway device without video capabilitySafeLM as a conduit for intubation using an endotracheal tube with video capabilitySafeLM as a conduit for intubation using a bougie with video capability

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Intubation success rate

Measured over at the time of intubation

Conditions

Anesthesia

Where it's being run

1 sites across 1 states

Texas1

Study leadership

Lauren M Nakazawa, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

Who to contact

Lauren M Nakazawa, MD

[email protected]

713-500-6775

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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)

What this trial measures

Intubation success rateat 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.

Trialytics