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Second Generation LMA Versus Endotracheal Tube in Obese Patients

Primary Purpose

Obese, Endotracheal Tube, Laryngeal Mask Airway

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Second-Generation Laryngeal Mask Airway
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obese

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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
  • 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

Sites / Locations

  • Parkland Health & Hospital System
  • MD Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard Endotracheal Tube

Second-Generation LMA

Arm Description

Outcomes

Primary Outcome Measures

Postoperative hypoxia
Patients in the 2 groups will be assessed for postoperative hypoxia in the PACU using a visual analog scale.

Secondary Outcome Measures

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

Full Information

First Posted
October 22, 2018
Last Updated
February 13, 2023
Sponsor
University of Texas Southwestern Medical Center
Collaborators
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03748342
Brief Title
Second Generation LMA Versus Endotracheal Tube in Obese Patients
Official Title
The Use of a Second-Generation Laryngeal Mask Airway Versus Endotracheal Tube in Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
M.D. Anderson Cancer Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese, Endotracheal Tube, Laryngeal Mask Airway

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Endotracheal Tube
Arm Type
No Intervention
Arm Title
Second-Generation LMA
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Second-Generation Laryngeal Mask Airway
Intervention Description
A second-generation LMA will be used for airway management (instead of ETT).
Primary Outcome Measure Information:
Title
Postoperative hypoxia
Description
Patients in the 2 groups will be assessed for postoperative hypoxia in the PACU using a visual analog scale.
Time Frame
Up to 80 minutes post-operatively
Secondary Outcome Measure Information:
Title
Alterations in blood pressure
Description
Blood pressure monitor readings will be recorded throughout the surgery and compared to baseline pre-operative values.
Time Frame
Intra-operatively
Title
Alterations in heart rate
Description
Heart rate monitor readings will be recorded throughout the surgery and compared to baseline pre-operative values.
Time Frame
Intra-operatively
Title
Alterations in oxygen saturation
Description
Oxygen saturation readings will be recorded throughout the surgery and compared to baseline pre-operative values.
Time Frame
Intra-operatively
Title
Alterations in respiratory rate
Description
Respiratory rate readings will be recorded throughout the surgery and compared to baseline pre-operative values.
Time Frame
Intra-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiffany S Moon, M.D.
Phone
469-419-5790
Email
tiffany.moon@utsouthwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Oh, B.S.
Phone
3106127741
Email
matthew.oh@utsouthwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiffany S Moon, M.D.
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkland Health & Hospital System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75211
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Kee, M.D.
Phone
713-792-6161
Email
skee@mdanderson.org

12. IPD Sharing Statement

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Second Generation LMA Versus Endotracheal Tube in Obese Patients

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