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Completed

NCT Number: NCT00668278

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

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.

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Key information

Conditions

Healthy

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Insertion of I-gel airway

Device

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

Measurement of airway pressures

Other

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

Primary outcomes

  1. Sealing pressure and peak airway pressure.

    Time frame: Under anaesthesia.

Secondary outcomes

  1. Postoperative patient symptoms

    Time frame: 1hr and 24hrs postoperatively

Sponsors and collaborators

Lead sponsor

Northern Health and Social Care Trust

Other Gov

Collaborators

  • Antrim Area Hospital

Registry information

Official study title

I-Gel Versus Disposable Laryngeal Mask Airway for General Anesthesia With Controlled Ventilation

Acronym: IGE(L)MA

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Apr 29, 2008
Registry last updated
Jan 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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