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

NCT01124825 | Withdrawn Phase 4

• 1 other identifier: UofL IRB #09.0619
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Anesthesia induction and maintenance; Surgery

Outcome Measures

Primary Outcomes (1)

• Airway Sealing Pressure

  Oropharyngeal leak pressure in cm H2O for the duration of the case at 1, 15, 30, 60, 120 minutes.

  1-3 hours

Secondary Outcomes (1)

• Difference in insertion time for one of the supraglottic airway devices

  1-3 hours

Study Arms (2)

IGel

ACTIVE COMPARATOR

Subjects will receive an IGel(TM) airway induction and maintenance of positive pressure ventilation

Device: IGEL

King Airway

ACTIVE COMPARATOR

Subject will receive a KING-LTS-D(TM) for induction and maintenance of positive pressure ventilation

Device: King airway

Interventions

IGEL DEVICE

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

IGel

King airway DEVICE

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

King Airway

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Related Publications (1)

• Kheterpal S, Martin L, Shanks AM, Tremper KK. Prediction and outcomes of impossible mask ventilation: a review of 50,000 anesthetics. Anesthesiology. 2009 Apr;110(4):891-7. doi: 10.1097/ALN.0b013e31819b5b87.

  PMID: 19293691 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Detlef Obal, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2010
• First Posted: May 17, 2010
• Study Start: July 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 14, 2012

Record last verified: 2012-11

Locations

US (1)