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Completed

NCT Number: NCT02816463

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

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.

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Key information

Conditions

Laryngeal Masks

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ambu AuraGain

Device

LMA Supreme

Device

Primary outcomes

  1. Oropharyngeal leak pressure (OLP) for each airway device after insertion

    Time frame: Within 2-3 minutes after laryngeal mask insertion before start of surgery.

    OLP is defined as 'the anesthesia circuit pressure at which a gas leak occurs around the SAD'.

Secondary outcomes

  1. Phrayngolaryngeal complications

    Time frame: at 1 hr, 2hr and 24 hrs after the surgery

    Complications like sore throat, dysphonia, dysphagia

  2. Postoperative nausea and vomiting (PONV)

    Time frame: at 1 hr, 2hr and 24 hrs after the surgery

    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.

  3. Satisfaction of patient and the anesthesiologist with the device

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

    Patient satisfaction (5 point scale)- 0 for very dissatisfied to 5 for very satisfied Anesthesiologist satisfaction scale- Low, Moderate and High

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: OLP-Aur/Sup

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 28, 2016
Registry last updated
Jun 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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