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

NCT02816463 | Completed

• 1 other identifier: 14-8360-B
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laryngeal Masks

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Phrayngolaryngeal complications

  at 1 hr, 2hr and 24 hrs after the surgery

• Postoperative nausea and vomiting (PONV)

  at 1 hr, 2hr and 24 hrs after the surgery

• Satisfaction of patient and the anesthesiologist with the device

  After 1hr in the post anesthesia care unit (PACU)

Study Arms (2)

Ambu AuraGain (Group A)

EXPERIMENTAL

Laryngeal mask Ambu AuraGain will be used, and oropharyngeal leak pressure (OLP) after insertion will be recorded as the primary outcome measure

Device: Ambu AuraGain

LMA Supreme (Group S)

ACTIVE COMPARATOR

Laryngeal mask Supreme will be used, and oropharyngeal leak pressure (OLP) after insertion will be recorded as the primary outcome measure

Device: LMA Supreme

Interventions

Ambu AuraGain DEVICE

Ambu AuraGain (Group A)

LMA Supreme DEVICE

LMA Supreme (Group S)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (1)

• Wong DT, Ooi A, Singh KP, Dallaire A, Meliana V, Lau J, Chung F, Singh M, Wong J. Comparison of oropharyngeal leak pressure between the Ambu(R) AuraGain and the LMA(R) Supreme supraglottic airways: a randomized-controlled trial. Can J Anaesth. 2018 Jul;65(7):797-805. doi: 10.1007/s12630-018-1120-4. Epub 2018 Mar 26.

  PMID: 29582360 DERIVED

Study Officials

• David T Wong, MD

  Uinversity Health Network (UHN), Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: June 28, 2016
• Study Start: June 1, 2016
• Primary Completion: May 9, 2017
• Study Completion: May 9, 2017
• Last Updated: June 6, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)