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

Trial ID or NCT#

NCT01124825

Status

not recruiting iconNOT RECRUITING

Purpose

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

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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).

Investigator(s)

Detlef Obal