N/A N=97 Randomized Other

Second Generation LMA Versus Endotracheal Tube in Obese Patients

Obese · Endotracheal Tube · Laryngeal Mask Airway

Bottom Line

View on ClinicalTrials.gov: NCT03748342 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcome: Primary: Proportion of Participants With Postoperative Hypoxia — 54.2; 34.7 percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Second-Generation Laryngeal Mask Airway (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Participants With Postoperative Hypoxia	54.2; 34.7	—
SECONDARY Alterations in Blood Pressure	0; 0	—
SECONDARY Alterations in Heart Rate	0; 0	—
SECONDARY Alterations in Oxygen Saturation (at Baseline)	0; 0	—
SECONDARY Alterations in Oxygen Saturation (at T15)	10; 10; 38; 39	—
SECONDARY Alterations in Oxygen Saturation (at T45)	3; 0; 3; 3; 42; 46	—
SECONDARY Alterations in Oxygen Saturation (at T80)	3; 0; 2; 1; 42; 48	—
SECONDARY Alterations in Respiratory Rate	16.33; 16.2	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03748342). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.