Clinical trial NCT03748342: Second Generation LMA Versus Endotracheal Tube in Obese Patients
Official title: The Use of a Second-Generation Laryngeal Mask Airway Versus Endotracheal Tube in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obese
Endotracheal Tube
Laryngeal Mask Airway
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
First posted: 2018-11-20
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Proportion of Participants With Postoperative Hypoxia
timeFrame: Up to 80 minutes post-operatively
Secondary outcomes:
measure: Alterations in Blood Pressure
timeFrame: Intra-operatively
measure: Alterations in Heart Rate
timeFrame: Intra-operatively
measure: Alterations in Oxygen Saturation (at Baseline)
timeFrame: Baseline
measure: Alterations in Oxygen Saturation (at T15)
timeFrame: at 15 mins postoperatively
measure: Alterations in Oxygen Saturation (at T45)
timeFrame: at 45 mins postoperatively
measure: Alterations in Oxygen Saturation (at T80)
timeFrame: at 80 mins postoperatively
measure: Alterations in Respiratory Rate
timeFrame: Baseline
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Health & Hospital System
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: University of Texas
name: Tiffany S Moon, M.D.
role: PRINCIPAL_INVESTIGATOR
References: