Second Generation LMA Versus Endotracheal Tube in Obese Patients

Not Applicable

Active, not recruiting

• Conditions: Endotracheal Tube; Obese; Laryngeal Mask Airway
• Interventions: Device: Second-Generation Laryngeal Mask Airway

• Registration Number: NCT03748342
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-22
• Study First Submitted QC: 2018-11-19
• Study First Posted: 2018-11-20
• Study Start: 2019-06-27
• Primary Completion: 2024-02-02
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-11
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Postoperative hypoxia	Up to 80 minutes post-operatively	Patients in the 2 groups will be assessed for postoperative hypoxia in the PACU using a visual analog scale.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Parkland Health & Hospital System; 🇺🇸 Dallas, Texas, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States