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Second Generation LMA Versus Endotracheal Tube in Obese Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03748342
Recruitment Status : Active, not recruiting
First Posted : November 20, 2018
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Tiffany B Moon, 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.

Condition or disease Intervention/treatment Phase
Obese Endotracheal Tube Laryngeal Mask Airway Device: Second-Generation Laryngeal Mask Airway Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Use of a Second-Generation Laryngeal Mask Airway Versus Endotracheal Tube in Obese Patients
Actual Study Start Date : June 27, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
No Intervention: Standard Endotracheal Tube
Active Comparator: Second-Generation LMA Device: Second-Generation Laryngeal Mask Airway
A second-generation LMA will be used for airway management (instead of ETT).




Primary Outcome Measures :
  1. Postoperative hypoxia [ Time Frame: 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 :
  1. Alterations in blood pressure [ Time Frame: Intra-operatively ]
    Blood pressure monitor readings 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 will be recorded throughout the surgery and compared to baseline pre-operative values.

  3. Alterations in oxygen saturation [ Time Frame: Intra-operatively ]
    Oxygen saturation readings will be recorded throughout the surgery and compared to baseline pre-operative values.

  4. Alterations in respiratory rate [ Time Frame: Intra-operatively ]
    Respiratory rate readings will be recorded throughout the surgery and compared to baseline pre-operative values.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748342


Locations
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United States, Texas
Parkland Health & Hospital System
Dallas, Texas, United States, 75211
Sponsors and Collaborators
University of Texas Southwestern Medical Center
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Responsible Party: Tiffany B Moon, Associate Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03748342    
Other Study ID Numbers: STU-112017-050
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms