Second Generation LMA Versus Endotracheal Tube in Obese Patients



Status:Not yet recruiting
Healthy:No
Age Range:18 - 80
Updated:2/28/2019
Start Date:April 2019
End Date:January 2021

Use our guide to learn which trials are right for you!

The Use of a Second-Generation Laryngeal Mask Airway Versus Endotracheal Tube in Obese Patients

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.


Inclusion Criteria:

- 18-80 years old

- Obese (BMI = 30 kg/m2-39.9 kg/m2)

- Morbidly Obese (BMI = 40 kg/m2-49.9 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)

- Uncontrolled diabetes (fasting CBG > 250 or HbA1c >7%)

- Surgery in position other than supine (e.g., Trendelenburg)

- Laparoscopic surgery
We found this trial at
1
site
?
mi
from
Dallas, TX
Click here to add this to my saved trials