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

This study has been withdrawn prior to enrollment.
(No subjects enrolled. Funding withdrawn by sponsor.)
Sponsor:
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT01124825
First received: May 12, 2010
Last updated: November 12, 2012
Last verified: November 2012
History of Changes
  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.


Condition Intervention Phase
Obesity
 Device: IGEL
Device: King airway
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Use of New Supraglottic Airway Devices in Severely Obese Patients: A Feasibility Study

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Airway Sealing Pressure [ Time Frame: 1-3 hours ] [ Designated as safety issue: Yes ]
    Oropharyngeal leak pressure in cm H2O for the duration of the case at 1, 15, 30, 60, 120 minutes.


Secondary Outcome Measures:
  • Difference in insertion time for one of the supraglottic airway devices [ Time Frame: 1-3 hours ] [ Designated as safety issue: Yes ]
    Effective airway time (time required to place the endotracheal tube/ supraglottic airway device).


Enrollment: 0
Study Start Date: July 2011
Study Completion Date: October 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 12, 2010
Last Updated: November 12, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013