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

November 12, 2012 updated by: University of Louisville
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Airway Sealing Pressure
Time Frame: 1-3 hours
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
Time Frame: 1-3 hours
Effective airway time (time required to place the endotracheal tube/ supraglottic airway device).
1-3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ANTICIPATED)

May 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

May 12, 2010

First Submitted That Met QC Criteria

May 13, 2010

First Posted (ESTIMATE)

May 17, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 14, 2012

Last Update Submitted That Met QC Criteria

November 12, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UofL IRB #09.0619

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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