NCT03748342Completed
Second Generation LMA Versus Endotracheal Tube in Obese Patients
The Use of a Second-Generation Laryngeal Mask Airway Versus Endotracheal Tube in Obese Patients
Source: ClinicalTrials.gov · Last updated 17 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 97 (actual)
- First submitted
- 22 Oct 2018
- Start date
- 27 Jun 2019
- Primary completion date
- 2 Feb 2024
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Obesity
- NCT number
- NCT03748342
What you commit to
- Study type: Interventional
- Participants enrolled: 97
- From 27 Jun 2019 to the primary completion date, 2 Feb 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Expected surgical duration longer than 4 hours
- Surgery in position other than supine (e.g., Trendelenburg)
- Laparoscopic surgery
Other illness
- Full stomach/significant aspiration risk (gastroparesis, emergency surgery, untreated moderate to severe gastroesophageal reflux disease, hiatal hernia)
- No history of gastric surgery
Age
- Age less than 18 or older than 80
Other
- BMI ≥50 or \< 30 kg/m2
- Patient does not speak English or Spanish
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Parkland Health & Hospital System Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.