Use of New Supraglottic Airway Devices in Severely Obese Patients: A Feasibility Study
Withdrawn before enrolling · Phase 4
Conditions studied: Obesity
In brief
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.
Key facts
- Study ID
- NCT01124825
- Run by
- University of Louisville
- People needed
- 0
- Starts
- 2011-07-01
- Expected to finish
- 2012-10-01
- Last updated by the study team
- 2012-11-14
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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).
Where it is running
- University of Louisville Hospital — Louisville, Kentucky, United States
Full record on ClinicalTrials.gov
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