Second Generation LMA Versus Endotracheal Tube in Obese Patients

NCT ID: NCT03748342

Last Updated: 2025-04-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-27

Study Completion Date

2025-02-03

Brief Summary

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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.

Detailed Description

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Conditions

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Obese Endotracheal Tube Laryngeal Mask Airway

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Standard Endotracheal Tube

Group Type NO_INTERVENTION

No interventions assigned to this group

Second-Generation LMA

Group Type ACTIVE_COMPARATOR

Second-Generation Laryngeal Mask Airway

Intervention Type DEVICE

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

Interventions

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Second-Generation Laryngeal Mask Airway

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Tiffany B Moon

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tiffany S Moon, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

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Parkland Health & Hospital System

Dallas, Texas, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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STU-112017-050

Identifier Type: -

Identifier Source: org_study_id

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