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

University of Louisville (UOFL)

Status and phase

Withdrawn

Phase 4

Conditions

Obesity

Treatments

Device: IGEL

Device: King airway

Study type

Interventional

Funder types

Other

Identifiers

NCT01124825

UofL IRB #09.0619

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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).