Use of New Supraglottic Airway Devices in Severely Obese Patients: A Feasibility Study
Phase 4
Withdrawn
- Conditions
- Obesity
- Interventions
- Device: IGELDevice: King airway
- Registration Number
- NCT01124825
- Lead Sponsor
- University of Louisville
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IGel IGEL Subjects will receive an IGel(TM) airway induction and maintenance of positive pressure ventilation King Airway King airway Subject will receive a KING-LTS-D(TM) for induction and maintenance of positive pressure ventilation
- Primary Outcome Measures
Name Time Method Airway Sealing Pressure 1-3 hours Oropharyngeal leak pressure in cm H2O for the duration of the case at 1, 15, 30, 60, 120 minutes.
- Secondary Outcome Measures
Name Time Method Difference in insertion time for one of the supraglottic airway devices 1-3 hours Effective airway time (time required to place the endotracheal tube/ supraglottic airway device).
Trial Locations
- Locations (1)
University of Louisville Hospital
🇺🇸Louisville, Kentucky, United States