CClinicalTrials.gg
Status unknownNCT01340638Updated Apr 22, 2011

Seal Pressure With Classical Laryngeal Mask and Cookgas Mask in Adult Patients

A Phase 3 interventional study of cookgas mask and LMA mask in Seal Pressure, sponsored by Universidad de Antioquia. Status unknown at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-04-22.

Sponsored by Universidad de Antioquia · Phase 3 and Interventional

The sponsor has not verified this record recently (last verified Apr 2011), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The working hypothesis in this study is that the supraglottic device COOKGAS provides seal pressure as well or better than LMAc ™ when adult patients undergoing outpatient surgery, are sommeted to both interventions.

02

Conditions studied

  • Seal Pressure

Keywords

  • Seal pressure
  • Cookgas
  • AirQ
  • LMA
  • supraglottic device
03

In context

Lead sponsor

Universidad de Antioquia is the lead sponsor of 79 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Over 18 years
  • Patient ASA I, II and III
  • Complete fast
  • Ambulatory Surgery
  • Time less than two hours surgically
  • Supine Surgery
  • Acceptance of informed consent

Exclusion criteria

Exclusion Criteria:

  • No acceptance of informed consent
  • Pregnancy or breastfeeding
  • Hemostatic alterations
  • Abdominal surgery
  • History of gastrointestinal reflux
  • BMI over 35
  • Mouth opening less than 1.5 cm
  • Airway abnormalities
  • Surgery in respiratory tract
05

Study design

Phase
Phase 3
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
106 participants (estimated)

Study arms

  • Active comparator
    Cookgas

    This group will be assigned to use cookgas mask

    Device: cookgas mask

  • Active comparator
    LMA mask

    This group will be assigned to use LMA mask

    Device: LMA mask

Interventions

  • Devicecookgas mask

    This group will be assigned to use cookgas mask

  • DeviceLMA mask

    LMA mask

06

What researchers measure

Primary outcomes

  1. Seal pressures

    The primary objective is to determine the effectiveness of the seal pressure between the mask COOKGAS ™ and LMAc in patients undergoing outpatient surgeries in ambulatory-based IPS, University of Antioquia (institution services health clinic) located in the city of Medellin.

    Time frame: six months

07

Study locations

1 site
  • Ips Universitaria
    Medellin, Antioquia, Colombia
    • IVAN D ARENAS, ANESTHETIST · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01340638
Lead sponsor
Universidad de Antioquia
Collaborators
Grupo de via aerea dificil universidad de antioquia
First posted
Apr 22, 2011
Start date
Jun 2011
Primary completion
Nov 2011 (estimated)
Completion
Dec 2011 (estimated)
Last update
Apr 22, 2011

Study contacts

NORA M MENDOZA, MD
Contact
MARCEMS2@YAHOO.COM
057 4 2506600
IVAN D ARENAS, ANESTHETIST
principal investigator · Universidad de Antioquia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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