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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Device: IGEL
* Device: King airway


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IGel<br>Subjects will receive an IGel(TM) airway induction and maintenance of positive pressure ventilation | Device: IGEL<br>* iGEL(TM) airway will be used for induction and maintenance of positive pressure ventilation<br>|
| Active Comparator: King Airway<br>Subject will receive a KING-LTS-D(TM) for induction and maintenance of positive pressure ventilation | Device: King airway<br>* KING-LTS-D(TM) airway will be used for induction and maintenance of positive pressure ventilation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway Sealing Pressure | Oropharyngeal leak pressure in cm H2O for the duration of the case at 1, 15, 30, 60, 120 minutes. | 1-3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in insertion time for one of the supraglottic airway devices | Effective airway time (time required to place the endotracheal tube/ supraglottic airway device). | 1-3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia induction and maintenance, Surgery