NCT00668278

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Feb 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

January 29, 2009

Status Verified

January 1, 2009

Enrollment Period

10 months

First QC Date

April 25, 2008

Last Update Submit

January 27, 2009

Conditions

Healthy

Keywords

Supraglottic airwayI-gelLaryngeal maskControlled ventilationPeak airway pressureSeal pressureAnaesthesiaSurgery

Outcome Measures

Primary Outcomes (1)

  • Sealing pressure and peak airway pressure.

    Under anaesthesia.

Secondary Outcomes (1)

  • Postoperative patient symptoms

    1hr and 24hrs postoperatively

Study Arms (2)

A

ACTIVE COMPARATOR

Laryngeal Mask Airway insertion

Device: Insertion of laryngeal mask airway (AuraOnce mask)Other: Measurement of airway pressures

B

ACTIVE COMPARATOR

I-gel insertion

Device: Insertion of I-gel airwayOther: Measurement of airway pressures

Interventions

Insertion of laryngeal mask airway (AuraOnce mask)DEVICE

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

A
Insertion of I-gel airwayDEVICE

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

B
Measurement of airway pressuresOTHER

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

AB

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females.
  • Age 18-89 inclusive.
  • ASA grade 1-2.
  • Elective surgery

You may not qualify if:

  • Emergency surgery.
  • Surgery within the peritoneum.
  • Surgery requiring prone or steep head-down positioning.
  • Patients at increased risk of aspiration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • William J Donaldson, MBBS FRCA

    Antrim Area Hospital, Northern Health and Social Care Trust, National Health Service, United Kingdom

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

April 25, 2008

First Posted

April 29, 2008

Study Start

February 1, 2008

Primary Completion

December 1, 2008

Study Completion

January 1, 2009

Last Updated

January 29, 2009

Record last verified: 2009-01