RECRUITING

Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Pilot Feasibility Trial of the SafeLM Supraglottic Airway

Quick Facts

Study Start:2023-09-19

Study Completion:2024-12-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05989880

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* elective surgery requiring general anesthesia and airway management using a supraglottic airway device or endotracheal intubation	* 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)

Inclusion Criteria

Exclusion Criteria

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

* 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)

Contacts and Locations

Study Contact

Lauren M Nakazawa, MD

CONTACT

713-500-6775

Lauren.M.Nakazawa@uth.tmc.edu

Carlos Artime, MD

CONTACT

713-500-6171

Carlos.Artime@uth.tmc.edu

Principal Investigator

Lauren M Nakazawa, MD

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Study Locations (Sites)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-19

Study Completion Date2024-12-02

Study Record Updates

Study Start Date2023-09-19

Study Completion Date2024-12-02

Terms related to this study

Additional Relevant MeSH Terms

Anesthesia