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

Universidad de Antioquia

Status and phase: Unknown; Phase 3

Conditions: Seal Pressure

Treatments: Device: cookgas mask; Device: LMA mask

Study type: Interventional

Funder types: Other

Identifiers

NCT01340638

UAntioquia SEAL- 001

Details and patient eligibility

About

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.

Enrollment: 106 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

106 participants in 2 patient groups

Cookgas

Active Comparator group

Description:

This group will be assigned to use cookgas mask

Treatment:

Device: cookgas mask

LMA mask

Active Comparator group

Description:

This group will be assigned to use LMA mask

Treatment:

Device: LMA mask