RCT:Oropharyngeal Leak Pressure (OLP) - Ambu AuraGain vs LMA Supreme

Laryngeal Masks Clinical Trial

— OLP-Aur/Sup  

Official title:

Comparison of Oropharyngeal Leak Pressure Between the Ambu AuraGain and the LMA Supreme - a Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02816463
• Other study ID #: 14-8360-B
• Status: Completed
• Phase: N/A
• First received: June 22, 2016
• Last updated: June 5, 2017
• Start date: June 2016
• Est. completion date: May 9, 2017

Study information

• Verified date: June 2017
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the leak pressure of the recently introduced laryngeal mask airway, Ambu AuraGain performs superior to the established laryngeal mask LMA Supreme in surgical patients undergoing general anesthesia. This leak pressure is the pressure at which a gas leaks around the airway, which is a key marker of efficacy and safety of its use; a higher leak pressure suggests a better seal between the artificial airway and patient's airway.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: May 9, 2017
• Est. primary completion date: May 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

ASA physical status I to III Adults more above 18 years Ambulatory surgeries under general anesthesia in supine position requiring laryngeal masks- Knee arthroscopies, bladder tumour resections, hand, eye and general surgical procedures Muscle relaxant not required

Exclusion Criteria

Reduced mouth opening less than 2.5 cms Recent upper respiratory tract infection and sore throat in last 2 weeks Contraindications to laryngeal mask use as in morbid obesity- BMI more than 40 and severe symptomatic esophageal reflux disease

Related Conditions & MeSH terms

• Laryngeal Masks

Intervention

Device:
• Ambu AuraGain

• LMA Supreme

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oropharyngeal leak pressure (OLP) for each airway device after insertion	OLP is defined as 'the anesthesia circuit pressure at which a gas leak occurs around the SAD'.	Within 2-3 minutes after laryngeal mask insertion before start of surgery.
Secondary	Phrayngolaryngeal complications	Complications like sore throat, dysphonia, dysphagia	at 1 hr, 2hr and 24 hrs after the surgery
Secondary	Postoperative nausea and vomiting (PONV)	PONV in the post anesthesia care unit (PACU)- PONV will be recorded as only None for No PONV and Yes for present. Severity grading will not be recorded.	at 1 hr, 2hr and 24 hrs after the surgery
Secondary	Satisfaction of patient and the anesthesiologist with the device	Patient satisfaction (5 point scale)- 0 for very dissatisfied to 5 for very satisfied Anesthesiologist satisfaction scale- Low, Moderate and High	After 1hr in the post anesthesia care unit (PACU)