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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01124825

Enrollment

Registered

2010-05-17

Start date

2011-07-31

Completion date

2012-10-31

Last updated

2012-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Anesthesia induction and maintenance, Surgery

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.

Interventions

DEVICEIGEL

iGEL(TM) airway will be used for induction and maintenance of positive pressure ventilation

DEVICEKing airway

KING-LTS-D(TM) airway will be used for induction and maintenance of positive pressure ventilation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026