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

NCT ID: NCT01124825

Last Updated: 2012-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Keywords

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Anesthesia induction and maintenance Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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IGel

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

Group Type ACTIVE_COMPARATOR

IGEL

Intervention Type DEVICE

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

King Airway

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

Group Type ACTIVE_COMPARATOR

King airway

Intervention Type DEVICE

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

Interventions

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IGEL

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

Intervention Type DEVICE

King airway

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

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Detlef Obal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

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University of Louisville Hospital

Louisville, Kentucky, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19293691 (View on PubMed)

Other Identifiers

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UofL IRB #09.0619

Identifier Type: -

Identifier Source: org_study_id