NCT01340638

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

April 19, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 22, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 22, 2011

Status Verified

April 1, 2011

Enrollment Period

5 months

First QC Date

April 19, 2011

Last Update Submit

April 20, 2011

Conditions

Seal Pressure

Keywords

Seal pressureCookgasAirQLMAsupraglottic device

Outcome Measures

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.

    six months

Study Arms (2)

Cookgas

ACTIVE COMPARATOR

This group will be assigned to use cookgas mask

Device: cookgas mask

LMA mask

ACTIVE COMPARATOR

This group will be assigned to use LMA mask

Device: LMA mask

Interventions

cookgas maskDEVICE

This group will be assigned to use cookgas mask

Cookgas
LMA maskDEVICE

LMA mask

LMA mask

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ips Universitaria

Medellín, Antioquia, Colombia

Location

Study Officials

  • IVAN D ARENAS, ANESTHETIST

    Universidad de Antioquia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

NORA M MENDOZA, MD

CONTACT

057 4 2506600MARCEMS2@YAHOO.COM

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 19, 2011

First Posted

April 22, 2011

Study Start

June 1, 2011

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

April 22, 2011

Record last verified: 2011-04

Locations

CO(1)