Second Generation LMA Versus Endotracheal Tube in Obese Patients

University of Texas Southwestern Medical Center97 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Obese Endotracheal Tube Laryngeal Mask Airway

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Parkland Health & Hospital System

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Proportion of Participants With Postoperative Hypoxia

Patients in the 2 groups will be assessed for postoperative hypoxia (1 or more episodes) in the PACU using a visual analog scale.

Time frame: Up to 80 minutes post-operatively

Secondary Outcomes

Alterations in Blood Pressure

Blood pressure monitor readings (events) will be recorded throughout the surgery and compared to baseline pre-operative values.

Time frame: Intra-operatively

Alterations in Heart Rate

Heart rate monitor readings (events) will be recorded throughout the surgery and compared to baseline pre-operative values.

Time frame: Intra-operatively

Alterations in Oxygen Saturation (at 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.

Time frame: Baseline

Alterations in Oxygen Saturation (at T15)

Oxygen saturation readings (at T15- after 15 mins in PACU) will be recorded throughout the surgery and compared to baseline pre-operative values.

Time frame: at 15 mins postoperatively

Alterations in Oxygen Saturation (at T45)

Oxygen saturation readings (at T45- after 45 mins in PACU) will be recorded throughout the surgery and compared to baseline pre-operative values.

Time frame: at 45 mins postoperatively

Alterations in Oxygen Saturation (at T80)

Oxygen saturation readings (at T80- after 80 mins in PACU) will be recorded throughout the surgery and compared to baseline pre-operative values.

Time frame: at 80 mins postoperatively

Alterations in Respiratory Rate

Respiratory rate readings (events) will be recorded at baseline.

Time frame: Baseline