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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01124825
• Other study ID #: UofL IRB #09.0619
• Status: Withdrawn
• Phase: Phase 4
• First received: May 12, 2010
• Last updated: November 12, 2012
• Start date: July 2011
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• IGEL
iGEL(TM) airway will be used for induction and maintenance of positive pressure ventilation
• King airway
KING-LTS-D(TM) airway will be used for induction and maintenance of positive pressure ventilation

Locations

Country	Name	City	State
United States	University of Louisville Hospital	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Difference in insertion time for one of the supraglottic airway devices	Effective airway time (time required to place the endotracheal tube/ supraglottic airway device).	1-3 hours	Yes