Second Generation LMA Versus Endotracheal Tube in Obese Patients

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Second-Generation LMA	Second-Generation Laryngeal Mask Airway	-

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With Postoperative Hypoxia	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 Outcome Measures

Name	Time	Method
Alterations in Blood Pressure	Intra-operatively	Blood pressure monitor readings (events) will be recorded throughout the surgery and compared to baseline pre-operative values.
Alterations in Heart Rate	Intra-operatively	Heart rate monitor readings (events) will be recorded throughout the surgery and compared to baseline pre-operative values.
Alterations in Oxygen Saturation (at Baseline)	Baseline	Oxygen saturation readings (events) will be recorded throughout the surgery and compared to baseline pre-operative values. Number of participants that did not require O2 is reported in the data table below.
Alterations in Oxygen Saturation (at T15)	at 15 mins postoperatively	Oxygen saturation readings (at T15- after 15 mins in PACU) will be recorded throughout the surgery and compared to baseline pre-operative values.
Alterations in Oxygen Saturation (at T45)	at 45 mins postoperatively	Oxygen saturation readings (at T45- after 45 mins in PACU) will be recorded throughout the surgery and compared to baseline pre-operative values.
Alterations in Oxygen Saturation (at T80)	at 80 mins postoperatively	Oxygen saturation readings (at T80- after 80 mins in PACU) will be recorded throughout the surgery and compared to baseline pre-operative values.
Alterations in Respiratory Rate	Baseline	Respiratory rate readings (events) will be recorded at baseline.