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This study has been withdrawn prior to enrollment.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 Funding withdrawn by sponsor.)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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014