Second Generation LMA Versus Endotracheal Tube in Obese Patients

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.

Official Title
-----------------
The Use of a Second-Generation Laryngeal Mask Airway Versus Endotracheal Tube in Obese Patients

Conditions
-----------------
Obese, Endotracheal Tube, Laryngeal Mask Airway

Intervention / Treatment
-----------------
* Device: Second-Generation Laryngeal Mask Airway


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Endotracheal Tube<br> | |
| Active Comparator: Second-Generation LMA<br> | Device: Second-Generation Laryngeal Mask Airway<br>* A second-generation LMA will be used for airway management (instead of ETT).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative hypoxia | Patients in the 2 groups will be assessed for postoperative hypoxia in the PACU using a visual analog scale. | Up to 80 minutes post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alterations in blood pressure | Blood pressure monitor readings will be recorded throughout the surgery and compared to baseline pre-operative values. | Intra-operatively | 
| Alterations in heart rate | Heart rate monitor readings will be recorded throughout the surgery and compared to baseline pre-operative values. | Intra-operatively | 
| Alterations in oxygen saturation | Oxygen saturation readings will be recorded throughout the surgery and compared to baseline pre-operative values. | Intra-operatively | 
| Alterations in respiratory rate | Respiratory rate readings will be recorded throughout the surgery and compared to baseline pre-operative values. | Intra-operatively |