- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04501068
Evaluation of the Ambu® AuraGain in Ambulatory Surgery
Analysis of 150 Consecutive Uses of the Ambu® AuraGain Supraglottic Airway by One Anaesthetist in Ambulatory Surgery
Study Overview
Detailed Description
Supraglottic devices (SGD), in all their different forms, have become an authentic innovation in airway management especially in day surgery. The Ambu® AuraGainTM (Ambu A/S, Ballerup, Denmark) is a new single-use, anatomically curved supraglottic airway with an integrated gastric access port designed to provide functional separation of the respiratory and digestive tracts allowing the exit of gastric contents and the passage of a gastric tube to manage gastric contents.
Its characteristics in the design, composition by a smooth and atraumatic material, the presence of the gastric drainage access, with potential improved patient safety and its characteristic of being disposable, suggests a significant expansion of its use in the coming years.
The series in the literature reporting performance or safety of use of the Ambu® AuraGainTM come from studies on selected cases and in certain surgical procedures. However, there are limited studies that have evaluated the efficacy of the device in routine clinical practice in patients intervened in ambulatory surgery and performed by a single investigator.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Madrid, Spain, 28007
- Hospital Universitario Gregorio Marañón
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Madrid, Spain
- Hospital Universitario Gregorio Marañón
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients undergoing surgery procedures in ambulatory surgery usually performed with supraglottic devices.
- ASA physical status I-III patients
- Age 18-no limit
Exclusion Criteria:
- Patients with known difficult airway
- Patients with increased risk of aspiration
- Patient refusal to participate in the study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Ambu AuraGain
Ambu® AuraGainTM Patients undergoing anesthesia in which airway management includes a Ambu® AuraGainTM supraglottic airway and fulfill the inclusion criteria of the study.
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Evaluate the time of insertion, performance, security and insertion success rate of the Ambu® AuraGainTM in patients undergoing ambulatory surgery and general anaesthesia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the number of attempts to insert the Ambu® AuraGainTM supraglottic airway
Time Frame: The number of insertion attempts will be collected after anesthesia induction
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Insertion attempts (in numbers) From picking up the Ambu® AuraGainTM supraglottic airway until the mask is placed into the patient mouth. (in numbers) |
The number of insertion attempts will be collected after anesthesia induction
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Evaluate the time to insert the Ambu® AuraGainTM supraglottic airway
Time Frame: The insertion time will be collected after anesthesia induction after administration of propofol
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The time from picking up the Ambu® AuraGainTM supraglottic airway until the cuff was inflated.
(in seconds)
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The insertion time will be collected after anesthesia induction after administration of propofol
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Blood pressure during insertion of the Ambu® AuraGainTM supraglottic airway
Time Frame: At baseline and every 3 minutes until 6 minutes after insertion of the Ambu® AuraGainTM supraglottic airway
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Blood pressure in mmHg
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At baseline and every 3 minutes until 6 minutes after insertion of the Ambu® AuraGainTM supraglottic airway
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Heart rate during insertion of the Ambu® AuraGainTM supraglottic airway heart rate
Time Frame: At baseline and every 3 minutes until 6 minutes after insertion of the Ambu® AuraGainTM supraglottic airway]
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Heart rate in beep per minute
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At baseline and every 3 minutes until 6 minutes after insertion of the Ambu® AuraGainTM supraglottic airway]
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BIS data
Time Frame: At baseline and every 3 minutes until 6 minutes after insertion of the Ambu® AuraGainTM supraglottic airway (To evaluate the evolution of BIS values during insertion of the Ambu® AuraGainTM supraglottic airway
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Bis data: number from 100 (awake) to 40-45 (anesthetic status)
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At baseline and every 3 minutes until 6 minutes after insertion of the Ambu® AuraGainTM supraglottic airway (To evaluate the evolution of BIS values during insertion of the Ambu® AuraGainTM supraglottic airway
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Oropharyngeal leak pressure of the Ambu® AuraGainTM supraglottic airway.
Time Frame: The Oropharyngeal leak pressure of the Ambu® AuraGainTM supraglottic airway will be collected 10 minutes after the Ambu® AuraGainTM supraglottic airway will be inserted]
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The Oropharyngeal leak pressure of the Ambu® AuraGainTM supraglottic airway will be determined with an intracuff pressure of 60 cm H2O by closing the expiratory valve of the breathing circle circuit at a fixed gas flow of 3 L/min and noting the pressure at which an oropharyngeal leak occurs.
(in cm H2O)
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The Oropharyngeal leak pressure of the Ambu® AuraGainTM supraglottic airway will be collected 10 minutes after the Ambu® AuraGainTM supraglottic airway will be inserted]
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Collaborators and Investigators
Investigators
- Study Chair: Javier Hortal, MD, PhD, Servicio de Anestesiología, Hospital General Universitario Gregorio Marañón
Publications and helpful links
General Publications
- 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.
- Lopez AM, Agusti M, Gambus P, Pons M, Anglada T, Valero R. A randomized comparison of the Ambu AuraGain versus the LMA supreme in patients undergoing gynaecologic laparoscopic surgery. J Clin Monit Comput. 2017 Dec;31(6):1255-1262. doi: 10.1007/s10877-016-9963-0. Epub 2016 Nov 26.
- Shariffuddin II, Teoh WH, Tang E, Hashim N, Loh PS. Ambu(R) AuraGain versus LMA Supreme Second Seal: a randomised controlled trial comparing oropharyngeal leak pressures and gastric drain functionality in spontaneously breathing patients. Anaesth Intensive Care. 2017 Mar;45(2):244-250. doi: 10.1177/0310057X1704500215.
- Preece G, Ng I, Lee K, Mezzavia P, Krieser R, Williams DL, Stewart O, Segal R. A randomised controlled trial comparing fibreoptic-guided tracheal intubation through two supraglottic devices: Ambu(R) AuraGain laryngeal mask and LMA(R) Fastrach. Anaesth Intensive Care. 2018 Sep;46(5):474-479. doi: 10.1177/0310057X1804600508.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MULTIAURAGAIN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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