Second Generation LMA Versus Endotracheal Tube in Obese Patients

The University of Texas System (UT)

Status

Completed

Conditions

Obese

Laryngeal Mask Airway

Endotracheal Tube

Treatments

Device: Second-Generation Laryngeal Mask Airway

Study type

Interventional

Funder types

Other

Identifiers

NCT03748342

STU-112017-050

Details and patient eligibility

About

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.

Enrollment

97 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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