Second Generation LMA Versus Endotracheal Tube in Obese Patients
NCT ID: NCT03748342
Last Updated: 2025-04-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
97 participants
INTERVENTIONAL
2019-06-27
2025-02-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Standard Endotracheal Tube
No interventions assigned to this group
Second-Generation LMA
Second-Generation Laryngeal Mask Airway
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Tiffany B Moon
Associate Professor
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
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STU-112017-050
Identifier Type: -
Identifier Source: org_study_id
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