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I-Gel Versus Disposable Laryngeal Mask (LMA) for General Anesthesia (GA) With Controlled Ventilation

NCT00668278 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2009-01-29

No results posted yet for this study

Summary

Randomized controlled trial comparing performance of the I-gel and disposable Laryngeal Mask Airways under controlled ventilation. 200 patients, 100 in each arm. Measurement of peak airway and sealing pressures. Postoperative questionnaires at 1 and 24hrs.

Hypothesis

There is no difference between the performance\* of the I-gel and disposable laryngeal mask airways for controlled ventilation under general anesthesia.

\*as defined by peak airway pressure and sealing pressures.

Conditions

  • Healthy

Interventions

DEVICE

Insertion of laryngeal mask airway (AuraOnce mask)

Insertion of laryngeal mask airway under anaesthesia: Fentanyl 1-2mcg/kg; Propofol 1-3mg/kg; Atracurium 0.5mg/kg; AuraOnce disposable laryngeal mask

DEVICE

Insertion of I-gel airway

Insertion of I-gel airway under anaesthesia; Fentanyl 1-2mcg/kg; Propofol 1-3mg/kg; Atracurium 0.5mg/kg

OTHER

Measurement of airway pressures

Measurement of peak airway pressure under steady state; measurement of device seal pressure

Sponsors & Collaborators

  • Antrim Area Hospital

    collaborator OTHER

  • Northern Health and Social Care Trust

    lead OTHER_GOV

Principal Investigators

  • William J Donaldson, MBBS FRCA · Antrim Area Hospital, Northern Health and Social Care Trust, National Health Service, United Kingdom

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-12-31
Completion
2009-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00668278 on ClinicalTrials.gov