Loading clinical trials...

Second Generation LMA Versus Endotracheal Tube in Obese Patients | Clinical Trials | Clareo Health

COMPLETEDNA

Second Generation LMA Versus Endotracheal Tube in Obese Patients

The Use of a Second-Generation Laryngeal Mask Airway Versus Endotracheal Tube in Obese Patients

NCT03748342•University of Texas Southwestern Medical Center

Summary

This prospective, randomized, comparative study is intended to enroll a total of 148 patients with a BMI 30-49.9 kg/m2 undergoing surgery at Parkland Hospital. The efficacy and performance of a second-generation LMA will be compared to endotracheal intubation. A standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. The remainder of the anesthetic care of the subject will not deviate from the standard of care.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•18-80 years old
•Obese (BMI \> or equal to 30 kg/m2
•Scheduled for a non-emergent surgery that requires general anesthesia (e.g., orthopedic, breast, urological, colorectal, ENT, vascular, general surgery)
•Willing and able to consent in English or Spanish
•No current history of advanced pulmonary or cardiac disease

Exclusion Criteria

•Age less than 18 or older than 80
•BMI ≥50 or \< 30 kg/m2
•Patient does not speak English or Spanish
•Expected surgical duration longer than 4 hours
•Planned postoperative ICU admission
•Patient refusal
•Monitored anesthesia care (MAC) or regional anesthesia planned
•Pregnant or nursing women
•"Stat" (emergent) cases
•Known or suspected difficult airway
+4 more criteria

Locations (2)

Parkland Health & Hospital System

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

June 27, 2019

Primary Completion Date

February 2, 2024

Completion Date

February 3, 2025

Last Updated

April 17, 2025

Enrollment

ACTUAL participants

Conditions

ObeseEndotracheal TubeLaryngeal Mask Airway

Interventions

Second-Generation Laryngeal Mask Airway

DEVICE

A 2-part, Phase 1b Clinical Study Designed to Evaluate the Safety, PK, and Efficacy of CRB-913 in Participants With Obesity

NCT07310901

Obese But Otherwise Healthy Participants

View study

RECRUITINGNA

Time-Restricted Eating for Weight-Loss Maintenance

NCT07163455

Overweight or Obese Adults

View study

RECRUITINGNA

Impact of Long Alimentary Limb or Long Biliary Limb Roux-en-Y Gastric Bypass on Type 2 Diabetes Remission in Severely Obese Patients.

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Second Generation LMA Versus Endotracheal Tube in Obese Patients

Inclusion Criteria

Exclusion Criteria

A 2-part, Phase 1b Clinical Study Designed to Evaluate the Safety, PK, and Efficacy of CRB-913 in Participants With Obesity

Time-Restricted Eating for Weight-Loss Maintenance

Impact of Long Alimentary Limb or Long Biliary Limb Roux-en-Y Gastric Bypass on Type 2 Diabetes Remission in Severely Obese Patients.

Study of the Efficacy and Safety of Nicotinamide in Patients With Liver Fibrosis (NICOFIB)

Stable Isotopes- Adults With Obesity

Prospective Study on the Consequences of Weight Loss After Bariatric Surgery on Obese Patients' Spine.