NCT00624403

Brief Summary

The i-gel is a new supra glottic airway device with a non inflatable cuff and an oesophageal vent. The aim of this study is to compare this device to the LMA ProSeal. The study is approved by the institutional ethic committee. 222 patients will be enrolled in each group. The objectives of the study will be to compare insertion success rate, leak pressure, ventilatory parameters and adverse event rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 27, 2008

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 10, 2015

Status Verified

January 1, 2014

Enrollment Period

5.8 years

First QC Date

February 15, 2008

Last Update Submit

March 9, 2015

Conditions

Endotracheal Intubation

Keywords

AnesthesiaLaryngeal mask airway

Outcome Measures

Primary Outcomes (1)

  • Insertion success rate

    At firste attempt of insertion

Secondary Outcomes (4)

  • Perioperative morbidity

    Perioperative period

  • Airway sealing pressure

    Once, when efficient ventilation is reached

  • Accessibility for stomach tube insertion

    Juste after laryngeal mask insertion

  • Fibre-optic grade

    After insertion

Study Arms (2)

1

ACTIVE COMPARATOR

LMA ProSeal

Device: Laryngeal mask insertion (LMA ProSeal)

2

EXPERIMENTAL

I-Gel

Device: Laryngeal mask insertion (I-Gel)

Interventions

Laryngeal mask insertion (LMA ProSeal)DEVICE

Laryngeal mask insertion

Also known as: LMA ProSeal
1
Laryngeal mask insertion (I-Gel)DEVICE

Laryngeal mask insertion

Also known as: I-Gel
2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Weight \> 30 kg
  • Surgery allowing the use of laryngeal mask as airway management
  • Written informed consent

You may not qualify if:

  • Difficult intubation criteria (defined by French Anesthesia-Reanimation Society)
  • Pulmonary disease
  • Gastroesophageal reflux antecedent
  • Coeliosurgery
  • Inhalation risk
  • Hiatus hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uniersity Hospital, Bordeaux

Bordeaux, 33000, France

Location

Related Publications (8)

  • Cros AM. [New laryngeal mask airway: easy and evolution to an better safety]. Ann Fr Anesth Reanim. 2006 Aug;25(8):804-5. doi: 10.1016/j.annfar.2006.06.009. Epub 2006 Jul 20. No abstract available. French.

    PMID: 16859880BACKGROUND

  • Asai T. Editorial II: Who is at increased risk of pulmonary aspiration? Br J Anaesth. 2004 Oct;93(4):497-500. doi: 10.1093/bja/aeh234. No abstract available.

    PMID: 15361474BACKGROUND

  • Cook TM, Lee G, Nolan JP. The ProSeal laryngeal mask airway: a review of the literature. Can J Anaesth. 2005 Aug-Sep;52(7):739-60. doi: 10.1007/BF03016565.

    PMID: 16103390BACKGROUND

  • Keller C, Brimacombe J, Kleinsasser A, Loeckinger A. Does the ProSeal laryngeal mask airway prevent aspiration of regurgitated fluid? Anesth Analg. 2000 Oct;91(4):1017-20. doi: 10.1097/00000539-200010000-00046.

    PMID: 11004067BACKGROUND

  • Brimacombe J, Richardson C, Keller C, Donald S. Mechanical closure of the vocal cords with the laryngeal mask airway ProSeal. Br J Anaesth. 2002 Feb;88(2):296-7. doi: 10.1093/bja/88.2.296.

    PMID: 11878665BACKGROUND

  • Levitan RM, Kinkle WC. Initial anatomic investigations of the I-gel airway: a novel supraglottic airway without inflatable cuff. Anaesthesia. 2005 Oct;60(10):1022-6. doi: 10.1111/j.1365-2044.2005.04258.x.

    PMID: 16179048BACKGROUND

  • Cook TM, McKinstry C, Hardy R, Twigg S. Randomized crossover comparison of the ProSeal laryngeal mask airway with the Laryngeal Tube during anaesthesia with controlled ventilation. Br J Anaesth. 2003 Nov;91(5):678-83. doi: 10.1093/bja/aeg239.

    PMID: 14570790BACKGROUND

  • Cook TM, Nolan JP, Verghese C, Strube PJ, Lees M, Millar JM, Baskett PJ. Randomized crossover comparison of the proseal with the classic laryngeal mask airway in unparalysed anaesthetized patients. Br J Anaesth. 2002 Apr;88(4):527-33. doi: 10.1093/bja/88.4.527.

    PMID: 12066729BACKGROUND

Study Officials

  • Anne-Marie CROS, Dr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2008

First Posted

February 27, 2008

Study Start

March 1, 2008

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 10, 2015

Record last verified: 2014-01

Locations

FR(1)