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Completed

NCT Number: NCT04501068

Evaluation of the Ambu® AuraGain in Ambulatory Surgery

The study was designed to evaluate the success rate, time of insertion, sealing efficacy and security of the Ambu® AuraGain in patients undergoing ambulatory surgery by one anesthetist

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Key information

Conditions

Airway

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Gregorio Maranon, Madrid, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Ambu® AuraGainTM

Device

Evaluate the time of insertion, performance, security and insertion success rate of the Ambu® AuraGainTM in patients undergoing ambulatory surgery and general anaesthesia

Primary outcomes

  1. 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

    Insertion attempts (in numbers)

    From picking up the Ambu® AuraGainTM supraglottic airway until the mask is placed into the patient mouth. (in numbers)

  2. 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

    The time from picking up the Ambu® AuraGainTM supraglottic airway until the cuff was inflated. (in seconds)

Secondary outcomes

  1. 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

    Blood pressure in mmHg

  2. 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]

    Heart rate in beep per minute

  3. 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

    Bis data: number from 100 (awake) to 40-45 (anesthetic status)

  4. 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]

    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)

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Gregorio Marañon

Other

Registry information

Official study title

Analysis of 150 Consecutive Uses of the Ambu® AuraGain Supraglottic Airway by One Anaesthetist in Ambulatory Surgery

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 6, 2020
Registry last updated
Aug 6, 2020

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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