Use of New Supraglottic Airway Devices in Severely Obese Patients: A Feasibility Study

University of Louisville1 site in 1 countryJuly 2011

ConditionsObesity

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Obesity
Sponsor: University of Louisville
Locations: 1
Primary Endpoint: Airway Sealing Pressure
Status: Withdrawn
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether two new airway devices used during anesthesia called iGEL™ and KING-LTS-DTM work well and are safe in obese patients. They both work well in thin patients, but have not been tested in obese patients.

Registry

clinicaltrials.gov

Start Date

July 2011

End Date

October 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Louisville

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Scheduled for elective surgery with an estimated duration of 30 to 120 minutes
•American Society of Anesthesiologists (ASA) status I-III
•Aged 18 to 65 years.
•Body mass index (BMI) ≥ 35 kg/m2

Exclusion Criteria

•A history of difficult intubation;
•Immobilized cervical spine;
•Oxygen saturation less than 95% at room air;
•A history of uncontrolled gastroesophageal reflux or hiatus hernia;
•A history of ulcer surgery including vagotomy;
•Previous gastric bypass surgery;
•Diabetic gastroparesis;
•Patients with known coagulation disorders (e.g. hemophilias, von Willebrand disease, factor V leiden diseases) or on systemic anticoagulation drugs (e.g. continuous heparin infusion); Patients with abnormal coagulation tests will be also excluded. However, asymptomatic patients will not be tested on any coagulation disorders.
•Any pathologies of the mouth, pharynx or larynx, the access to the airway is restricted, or a difficult tracheal intubation is anticipated.
•Pregnant or breast-feeding (pregnancy status will be confirmed by a pregnancy test, as it is standard for all surgical procedures at the University hospital).