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NCT Number: NCT03748342

Second Generation LMA Versus Endotracheal Tube in Obese Patients

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.

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Key information

Conditions

Obese Body Weight Endotracheal Tube Laryngeal Mask Airway Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parkland Health & Hospital System, Dallas, Texas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Second-Generation Laryngeal Mask Airway

Device

A second-generation LMA will be used for airway management (instead of ETT).

Primary outcomes

  1. 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

  1. Alterations in Blood Pressure

    Time frame: Intra-operatively

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

  2. Alterations in Heart Rate

    Time frame: Intra-operatively

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

  3. Alterations in Oxygen Saturation (at Baseline)

    Time frame: 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.

  4. Alterations in Oxygen Saturation (at T15)

    Time frame: 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.

  5. Alterations in Oxygen Saturation (at T45)

    Time frame: 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.

  6. Alterations in Oxygen Saturation (at T80)

    Time frame: 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.

  7. Alterations in Respiratory Rate

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • M.D. Anderson Cancer Center

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Nov 20, 2018
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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