Second Generation LMA Versus Endotracheal Tube in Obese Patients

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obese; Endotracheal Tube; Laryngeal Mask Airway
• Intervention / Treatment: Device: Second-Generation Laryngeal Mask Airway

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75211
      • Parkland Health & Hospital System
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Endotracheal Tube
Active Comparator: Second-Generation LMA	Device: Second-Generation Laryngeal Mask Airway; A second-generation LMA will be used for airway management (instead of ETT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative hypoxia	Patients in the 2 groups will be assessed for postoperative hypoxia in the PACU using a visual analog scale.	Up to 80 minutes post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alterations in blood pressure	Blood pressure monitor readings will be recorded throughout the surgery and compared to baseline pre-operative values.	Intra-operatively
Alterations in heart rate	Heart rate monitor readings will be recorded throughout the surgery and compared to baseline pre-operative values.	Intra-operatively
Alterations in oxygen saturation	Oxygen saturation readings will be recorded throughout the surgery and compared to baseline pre-operative values.	Intra-operatively
Alterations in respiratory rate	Respiratory rate readings will be recorded throughout the surgery and compared to baseline pre-operative values.	Intra-operatively

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Tiffany S Moon, M.D., University of Texas

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2019
• Primary Completion (Actual): February 2, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: October 22, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: STU-112017-050

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes