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

Seal Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01340638
• Other study ID #: UAntioquia SEAL- 001
• Status: Not yet recruiting
• Phase: Phase 3
• First received: April 19, 2011
• Last updated: April 20, 2011
• Start date: June 2011
• Est. completion date: December 2011

Study information

• Verified date: April 2011
• Source: Universidad de Antioquia
• Contact: NORA M MENDOZA, MD
• Phone: 057 4 2506600
• Email: MARCEMS2[@]YAHOO.COM
• Is FDA regulated: No
• Health authority: Colombia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 106
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Seal Pressure

Intervention

Device:
• cookgas mask
This group will be assigned to use cookgas mask
• LMA mask
LMA mask

Locations

Country	Name	City	State
Colombia	Ips Universitaria	Medellin	Antioquia

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Antioquia	Grupo de via aerea dificil universidad de antioquia

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes