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

NCT ID: NCT01340638

Last Updated: 2011-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Seal Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Cookgas

This group will be assigned to use cookgas mask

Group Type ACTIVE_COMPARATOR

cookgas mask

Intervention Type DEVICE

This group will be assigned to use cookgas mask

LMA mask

This group will be assigned to use LMA mask

Group Type ACTIVE_COMPARATOR

LMA mask

Intervention Type DEVICE

LMA mask

Interventions

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cookgas mask

This group will be assigned to use cookgas mask

Intervention Type DEVICE

LMA mask

LMA mask

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Grupo de via aerea dificil universidad de antioquia

UNKNOWN

Sponsor Role collaborator

Universidad de Antioquia

OTHER

Sponsor Role lead

Responsible Party

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Universidad de Antioquia

Principal Investigators

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IVAN D ARENAS, ANESTHETIST

Role: PRINCIPAL_INVESTIGATOR

Universidad de Antioquia

Locations

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Ips Universitaria

Medellín, Antioquia, Colombia

Site Status

Countries

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Colombia

Central Contacts

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NORA M MENDOZA, MD

Role: CONTACT

057 4 2506600

Other Identifiers

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UAntioquia SEAL- 001

Identifier Type: -

Identifier Source: org_study_id

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