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

April 20, 2011 updated by: Universidad de Antioquia

EFFECTIVENESS OF SEAL PRESSURE IN AIRWAY OF THE CLASSIC LARYNGEAL MASK AND THE COOKGAS LARYNGEAL MASK IN ADULT PATIENTS UNDERGOING SURGERY IN AMBULATORY SETTINGS

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

106

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • IPS Universitaria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cookgas
This group will be assigned to use cookgas mask
Device: cookgas mask
This group will be assigned to use cookgas mask
Active Comparator: LMA mask
This group will be assigned to use LMA mask
Device: LMA mask
LMA mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seal pressures
Time Frame: six months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Antioquia

Collaborators

Grupo de via aerea dificil universidad de antioquia

Investigators

  • Principal Investigator: IVAN D ARENAS, ANESTHETIST, Universidad de Antioquia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

November 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

April 19, 2011

First Submitted That Met QC Criteria

April 20, 2011

First Posted (Estimate)

April 22, 2011

Study Record Updates

Last Update Posted (Estimate)

April 22, 2011

Last Update Submitted That Met QC Criteria

April 20, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UAntioquia SEAL- 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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