Second Generation LMA Versus Endotracheal Tube in Obese Patients
Completed · Not applicable
Conditions studied: Obese, Endotracheal Tube, Laryngeal Mask Airway
In brief
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.
Key facts
- Study ID
- NCT03748342
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 97
- Starts
- 2019-06-27
- Expected to finish
- 2025-02-03
- Last updated by the study team
- 2025-04-17
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
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
Where it is running
- Parkland Health & Hospital System — Dallas, Texas, United States
- MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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