Second Generation LMA Versus Endotracheal Tube in Obese Patients

Obese Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03748342
• Other study ID #: STU-112017-050
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 27, 2019
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: June 2024
• Est. primary completion date: February 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

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

Related Conditions & MeSH terms

• Endotracheal Tube
• Laryngeal Mask Airway
• Obese
• Obesity

Intervention

Device:
• Second-Generation Laryngeal Mask Airway
A second-generation LMA will be used for airway management (instead of ETT).

Locations

Country	Name	City	State
United States	Parkland Health & Hospital System	Dallas	Texas
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Alterations in blood pressure	Blood pressure monitor readings will be recorded throughout the surgery and compared to baseline pre-operative values.	Intra-operatively
Secondary	Alterations in heart rate	Heart rate monitor readings will be recorded throughout the surgery and compared to baseline pre-operative values.	Intra-operatively
Secondary	Alterations in oxygen saturation	Oxygen saturation readings will be recorded throughout the surgery and compared to baseline pre-operative values.	Intra-operatively
Secondary	Alterations in respiratory rate	Respiratory rate readings will be recorded throughout the surgery and compared to baseline pre-operative values.	Intra-operatively