The Use of a Second-Generation Laryngeal Mask Airway Versus Endotracheal Tube in Obese Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 97
- Locations
- 2
- Primary Endpoint
- Proportion of Participants With Postoperative Hypoxia
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Standard Endotracheal Tube
Second-Generation LMA
Intervention: Second-Generation Laryngeal Mask Airway (Device)
Outcomes
Primary Outcomes
Proportion of Participants With Postoperative Hypoxia
Time Frame: Up to 80 minutes post-operatively
Patients in the 2 groups will be assessed for postoperative hypoxia (1 or more episodes) in the PACU using a visual analog scale.
Secondary Outcomes
- Alterations in Oxygen Saturation (at T80)(at 80 mins postoperatively)
- Alterations in Respiratory Rate(Baseline)
- Alterations in Blood Pressure(Intra-operatively)
- Alterations in Heart Rate(Intra-operatively)
- Alterations in Oxygen Saturation (at Baseline)(Baseline)
- Alterations in Oxygen Saturation (at T15)(at 15 mins postoperatively)
- Alterations in Oxygen Saturation (at T45)(at 45 mins postoperatively)
Investigators
Tiffany B Moon
Associate Professor
University of Texas Southwestern Medical Center