NCT05989880 Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)
| NCT ID | NCT05989880 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Anesthesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-09-19 |
| Primary Completion | 2025-10-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-09-19 with a primary completion date of 2025-10-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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)
Contact & Investigator
Lauren M Nakazawa, MD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT05989880 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anesthesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05989880 currently recruiting?
Yes, NCT05989880 is actively recruiting participants. Contact the research team at Lauren.M.Nakazawa@uth.tmc.edu for enrollment information.
Where is the NCT05989880 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05989880 clinical trial?
NCT05989880 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Lauren M Nakazawa, MD at The University of Texas Health Science Center, Houston. The trial plans to enroll 60 participants.