<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04501068</url>
  </required_header>
  <id_info>
    <org_study_id>MULTIAURAGAIN</org_study_id>
    <nct_id>NCT04501068</nct_id>
  </id_info>
  <brief_title>Evaluation of the Ambu® AuraGain in Ambulatory Surgery</brief_title>
  <official_title>Analysis of 150 Consecutive Uses of the Ambu® AuraGain Supraglottic Airway by One Anaesthetist in Ambulatory Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital General Universitario Gregorio Marañon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital General Universitario Gregorio Marañon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study was designed to evaluate the success rate, time of insertion, sealing efficacy and&#xD;
      security of the Ambu® AuraGain in patients undergoing ambulatory surgery by one anesthetist&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Supraglottic devices (SGD), in all their different forms, have become an authentic innovation&#xD;
      in airway management especially in day surgery. The Ambu® AuraGainTM (Ambu A/S, Ballerup,&#xD;
      Denmark) is a new single-use, anatomically curved supraglottic airway with an integrated&#xD;
      gastric access port designed to provide functional separation of the respiratory and&#xD;
      digestive tracts allowing the exit of gastric contents and the passage of a gastric tube to&#xD;
      manage gastric contents.&#xD;
&#xD;
      Its characteristics in the design, composition by a smooth and atraumatic material, the&#xD;
      presence of the gastric drainage access, with potential improved patient safety and its&#xD;
      characteristic of being disposable, suggests a significant expansion of its use in the coming&#xD;
      years.&#xD;
&#xD;
      The series in the literature reporting performance or safety of use of the Ambu® AuraGainTM&#xD;
      come from studies on selected cases and in certain surgical procedures. However, there are&#xD;
      limited studies that have evaluated the efficacy of the device in routine clinical practice&#xD;
      in patients intervened in ambulatory surgery and performed by a single investigator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the number of attempts to insert the Ambu® AuraGainTM supraglottic airway</measure>
    <time_frame>The number of insertion attempts will be collected after anesthesia induction</time_frame>
    <description>Insertion attempts (in numbers)&#xD;
From picking up the Ambu® AuraGainTM supraglottic airway until the mask is placed into the patient mouth. (in numbers)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the time to insert the Ambu® AuraGainTM supraglottic airway</measure>
    <time_frame>The insertion time will be collected after anesthesia induction after administration of propofol</time_frame>
    <description>The time from picking up the Ambu® AuraGainTM supraglottic airway until the cuff was inflated. (in seconds)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure during insertion of the Ambu® AuraGainTM supraglottic airway</measure>
    <time_frame>At baseline and every 3 minutes until 6 minutes after insertion of the Ambu® AuraGainTM supraglottic airway</time_frame>
    <description>Blood pressure in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate during insertion of the Ambu® AuraGainTM supraglottic airway heart rate</measure>
    <time_frame>At baseline and every 3 minutes until 6 minutes after insertion of the Ambu® AuraGainTM supraglottic airway]</time_frame>
    <description>Heart rate in beep per minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BIS data</measure>
    <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</time_frame>
    <description>Bis data: number from 100 (awake) to 40-45 (anesthetic status)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oropharyngeal leak pressure of the Ambu® AuraGainTM supraglottic airway.</measure>
    <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]</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Airway</condition>
  <arm_group>
    <arm_group_label>Ambu AuraGain</arm_group_label>
    <description>Ambu® AuraGainTM Patients undergoing anesthesia in which airway management includes a Ambu® AuraGainTM supraglottic airway and fulfill the inclusion criteria of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ambu® AuraGainTM</intervention_name>
    <description>Evaluate the time of insertion, performance, security and insertion success rate of the Ambu® AuraGainTM in patients undergoing ambulatory surgery and general anaesthesia</description>
    <arm_group_label>Ambu AuraGain</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients scheduled for outpatient surgery. Patients who require the insertion of a&#xD;
        supraglottic device as part of their anesthetic management.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing surgery procedures in ambulatory surgery usually performed with&#xD;
             supraglottic devices.&#xD;
&#xD;
          -  ASA physical status I-III patients&#xD;
&#xD;
          -  Age 18-no limit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known difficult airway&#xD;
&#xD;
          -  Patients with increased risk of aspiration&#xD;
&#xD;
          -  Patient refusal to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Javier Hortal, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Servicio de Anestesiología, Hospital General Universitario Gregorio Marañón</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario Gregorio Marañon</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Gregorio Maranon</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>28267947</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>29582360</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>27889843</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>30189821</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital General Universitario Gregorio Marañon</investigator_affiliation>
    <investigator_full_name>Matilde Zaballos</investigator_full_name>
    <investigator_title>Anesthesiologist</investigator_title>
  </responsible_party>
  <keyword>Ambu® AuraGainTM</keyword>
  <keyword>Second Generation Laryngeal Masks Airway</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04501068
org study id: MULTIAURAGAIN
nct id: NCT04501068
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
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.
observational model: Cohort
time perspective: Prospective
measure: 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
description: Insertion attempts (in numbers)
From picking up the Ambu® AuraGainTM supraglottic airway until the mask is placed into the patient mouth. (in numbers)
measure: 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
description: The time from picking up the Ambu® AuraGainTM supraglottic airway until the cuff was inflated. (in seconds)
measure: 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
description: Blood pressure in mmHg
measure: 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]
description: Heart rate in beep per minute
measure: 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
description: Bis data: number from 100 (awake) to 40-45 (anesthetic status)
measure: 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]
description: 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)
arm group label: Ambu AuraGain
description: Ambu® AuraGainTM Patients undergoing anesthesia in which airway management includes a Ambu® AuraGainTM supraglottic airway and fulfill the inclusion criteria of the study.
intervention type: Device
intervention name: Ambu® AuraGainTM
description: Evaluate the time of insertion, performance, security and insertion success rate of the Ambu® AuraGainTM in patients undergoing ambulatory surgery and general anaesthesia
arm group label: Ambu AuraGain
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Javier Hortal, MD, PhD
role: Study Chair
affiliation: Servicio de Anestesiología, Hospital General Universitario Gregorio Marañón
facility: 
facility: 
country: Spain
citation: 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.
PMID: 28267947
citation: 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
citation: 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.
PMID: 27889843
citation: 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.
PMID: 30189821
responsible party type: Principal Investigator
investigator affiliation: Hospital General Universitario Gregorio Marañon
investigator full name: Matilde Zaballos
investigator title: Anesthesiologist
sharing ipd: No