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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03748342
Other study ID # STU-112017-050
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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