Second Generation LMA Versus Endotracheal Tube in Obese Patients

NCT03748342 | Completed Results DMC FDA Device

• 1 other identifier: STU-112017-050
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Obese; Endotracheal Tube; Laryngeal Mask Airway

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With Postoperative Hypoxia

  Patients in the 2 groups will be assessed for postoperative hypoxia (1 or more episodes) in the PACU using a visual analog scale.

  Up to 80 minutes post-operatively

Secondary Outcomes (7)

• Alterations in Blood Pressure

  Intra-operatively

• Alterations in Heart Rate

  Intra-operatively

• Alterations in Oxygen Saturation (at Baseline)

  Baseline

• Alterations in Oxygen Saturation (at T15)

  at 15 mins postoperatively

• Alterations in Oxygen Saturation (at T45)

  at 45 mins postoperatively

Study Arms (2)

Standard Endotracheal Tube

NO INTERVENTION

Second-Generation LMA

ACTIVE COMPARATOR

Device: Second-Generation Laryngeal Mask Airway

Interventions

Second-Generation Laryngeal Mask Airway DEVICE

A second-generation LMA will be used for airway management (instead of ETT).

Second-Generation LMA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Full stomach/significant aspiration risk (gastroparesis, emergency surgery, untreated moderate to severe gastroesophageal reflux disease, hiatal hernia)
• No history of gastric surgery
• Surgery in position other than supine (e.g., Trendelenburg)
• Laparoscopic surgery

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• M.D. Anderson Cancer Center: collaborator

Study Sites (2)

Parkland Health & Hospital System

Dallas, Texas, 75211, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Tiffany Moon
• Organization: UT Southwestern Medical Center

Tiffany.Moon@UTSouthwestern.edu

469/419-5790

Study Officials

• Tiffany S Moon, M.D.

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: November 20, 2018
• Study Start: June 27, 2019
• Primary Completion: February 2, 2024
• Study Completion: February 3, 2025
• Last Updated: April 17, 2025
• Results First Posted: April 17, 2025

Record last verified: 2025-03

Locations

US (2)