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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01124825
Recruitment Status : Withdrawn (No subjects enrolled. Funding withdrawn by sponsor.)
First Posted : May 17, 2010
Last Update Posted : November 14, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Obesity Device: IGEL Device: King airway Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Use of New Supraglottic Airway Devices in Severely Obese Patients: A Feasibility Study
Study Start Date : July 2011
Estimated Primary Completion Date : May 2012
Study Completion Date : October 2012
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01124825


Locations
United States, Kentucky
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Detlef Obal, MD University of Louisville
More Information

Publications:
Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT01124825     History of Changes
Other Study ID Numbers: UofL IRB #09.0619
First Posted: May 17, 2010    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: November 2012

Keywords provided by University of Louisville:
Anesthesia induction and maintenance
Surgery