<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/NCT03272776</url>
  </required_header>
  <id_info>
    <org_study_id>MASKAPROTECTOR</org_study_id>
    <nct_id>NCT03272776</nct_id>
  </id_info>
  <brief_title>Multicenter Study of the Protector Laryngeal Mask</brief_title>
  <official_title>A Multicenter Study of the Protector Laryngeal Mask in Non Paralyzed, Anesthetized Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Matilde Zaballos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Teleflex</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </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 Protector Laryngeal Mask, a new second generation disposable supraglottic&#xD;
      airway device, in patients undergoing elective surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Laryngeal masks (LM) and supraglottic devices (SGD), in all their different forms, have&#xD;
      become an authentic innovation in airway management especially in day surgery.&#xD;
&#xD;
      LMA Protector (Teleflex Medical, Athlone, Ireland) is a new disposable SGD currently&#xD;
      available for anaesthetic practice. It is made of silicone (with no latex in its composition)&#xD;
      and shares some of the characteristics of the second generation SGDs (as the presence of a&#xD;
      gastric access channel); however, it has an additional drainage channel, both channels&#xD;
      terminate distally in a camera behind the mask cuff. The presence of two drainage channels&#xD;
      (&quot;male&quot; and &quot;female&quot;) increases the patient safety against regurgitation, both of distal&#xD;
      gastric content and secretions located in the oropharyngeal region. The gastric access&#xD;
      channel called &quot;female&quot; also allows the insertion of a nasogastric tube if required. These&#xD;
      drainage channels are useful for diagnosing the correct position of the mask, since the&#xD;
      observation of leaks or gas through it can help diagnose a displacement the mask.&#xD;
&#xD;
      LMA Protector is designed with a preformed anatomic curve, and the airway conduct has an&#xD;
      elliptical cross section, which ends distally in the mask. This design follows the anatomy of&#xD;
      the human airway, which facilitates the insertion of the device. The softness of the mask&#xD;
      material allows easy insertion.&#xD;
&#xD;
      Doubts regarding the transmission of infectious diseases with reusable devices makes&#xD;
      disposable devices such as LMA Protector, one of the most interesting devices for use in&#xD;
      anaesthetic procedures that are usually performed with SGD.&#xD;
&#xD;
      Its characteristics in the design, composition by a smooth and atraumatic material, the&#xD;
      presence of two gastric drainage accesses, 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;
      In contrast to other SGDs that have been evaluated extensively, to date there are no large&#xD;
      clinical studies showing its suitably and performance in a daily clinical scenario.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">July 30, 2018</completion_date>
  <primary_completion_date type="Actual">July 30, 2018</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 of the LMA Protector</measure>
    <time_frame>The number of insertion attempts will be collected after anesthesia induction: 1 minute after the administration of propofol</time_frame>
    <description>Insertion attempts: from picking up the LMA Protector until the mask is placed into the patient mouth . (in numbers)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure during insertion of LMA protect</measure>
    <time_frame>Baseline and every 3 minutes until 6 minutes after insertion of the LMA protector</time_frame>
    <description>Blood pressure in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate during insertion of LMA protect</measure>
    <time_frame>Baseline and every 3 minutes until 6 minutes after insertion of the LMA protector</time_frame>
    <description>heart rate in beep per minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BIS data</measure>
    <time_frame>Baseline and every 3 minutes until 6 minutes after insertion of the LMA protector (To evaluate the evolution of BIS values during insertion of the LMA</time_frame>
    <description>number from 100 (awake) to 40-45 (anesthetic status)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oropharyngeal leak pressure of the LMA Protector</measure>
    <time_frame>The Oropharyngeal leak pressure of the LMA Protector will be collected 5 minutes after the LMA Protector will be inserted</time_frame>
    <description>The Oropharyngeal leak pressure of the LMA Protector 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">280</enrollment>
  <condition>Airway</condition>
  <arm_group>
    <arm_group_label>Protector Laryngeal Mask Airway</arm_group_label>
    <description>Patients undergoing anesthesia in which airway management includes a Protector Laryngeal Mask and fulfill the inclusion criteria of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Protector Laryngeal Mask airway</intervention_name>
    <description>Evaluate the time of insertion, performance, security and insertion success rate of the Protector Laryngeal Mask in patients under general anasthesia.</description>
    <arm_group_label>Protector Laryngeal Mask Airway</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing surgery procedures in any of the collaborating centers of the study&#xD;
        that fulfill the inclusion and exclusion criteria described below.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Surgery procedures usually performed with supraglottic devices.&#xD;
&#xD;
          -  ASA physical status I-III patients&#xD;
&#xD;
          -  Age 18-75&#xD;
&#xD;
          -  Signed inform consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known difficult airway&#xD;
&#xD;
          -  Patients with predicted 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>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maite López-Gil</last_name>
    <role>Study Chair</role>
    <affiliation>Servicio de Anestesiología, Hospital General Universitario Gregorio Marañon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Servicio de Anestesia, Hospital General Universitario Gregorio Marañon</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Brimacombe JR, editor. Laryngeal Mask Anesthesia. Principles and practice. 2nd Ed. Filadelfia. 2005.</citation>
  </reference>
  <reference>
    <citation>Van Zundert AA, Skinner MW, Van Zundert TC, Luney SR, Pandit JJ. Value of knowing physical characteristics of the airway device before using it. Br J Anaesth. 2016 Jul;117(1):12-6. doi: 10.1093/bja/aew106. Epub 2016 May 4. No abstract available.</citation>
    <PMID>27147543</PMID>
  </reference>
  <reference>
    <citation>Zaballos García M, López Álvarez S, Agustí Martínez-Marcos S, Blanco Sánchez T, Bustos Molina F, Cabré Fabré P, et al. Nuevas aportaciones de la mascarilla laríngea en cirugía ambulatoria. Contribución de la mascarilla laríngea Supreme. Cir May Amb 2011; 16(2): 60-6.</citation>
  </reference>
  <reference>
    <citation>Zaballos García M, López Álvarez S, Agustí Martínez-Marcos S, Blanco Sánchez T, Bustos Molina F, Cabré Fabré P, Cordero Lorenzo JM, Izquierdo Villaroya B, Lafuente Ojeda N, M. López Gil M, Rodríguez Archilla A, Zaballos Bustingorri J Recomendaciones prácticas de uso de la mascarilla laríngea en Cirugía Ambulatoria. Cir May Amb 2008; 13: (1) 4-26.</citation>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>February 20, 2019</last_update_submitted>
  <last_update_submitted_qc>February 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-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>LMA Protector</keyword>
  <keyword>Second Generation Laryngeal Masks</keyword>
  <keyword>Airway</keyword>
  <keyword>Dual Gastric Acces</keyword>
  <keyword>Teleflex</keyword>
  <keyword>Supraglottic Devices</keyword>
  <keyword>Ambulatory Surgery</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/NCT03272776
org study id: MASKAPROTECTOR
nct id: NCT03272776
lead sponsor: 
collaborator: 
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 Protector Laryngeal Mask, a new second generation disposable supraglottic
      airway device, in patients undergoing elective surgery.
Laryngeal masks (LM) and supraglottic devices (SGD), in all their different forms, have
      become an authentic innovation in airway management especially in day surgery.

      LMA Protector (Teleflex Medical, Athlone, Ireland) is a new disposable SGD currently
      available for anaesthetic practice. It is made of silicone (with no latex in its composition)
      and shares some of the characteristics of the second generation SGDs (as the presence of a
      gastric access channel); however, it has an additional drainage channel, both channels
      terminate distally in a camera behind the mask cuff. The presence of two drainage channels
      ("male" and "female") increases the patient safety against regurgitation, both of distal
      gastric content and secretions located in the oropharyngeal region. The gastric access
      channel called "female" also allows the insertion of a nasogastric tube if required. These
      drainage channels are useful for diagnosing the correct position of the mask, since the
      observation of leaks or gas through it can help diagnose a displacement the mask.

      LMA Protector is designed with a preformed anatomic curve, and the airway conduct has an
      elliptical cross section, which ends distally in the mask. This design follows the anatomy of
      the human airway, which facilitates the insertion of the device. The softness of the mask
      material allows easy insertion.

      Doubts regarding the transmission of infectious diseases with reusable devices makes
      disposable devices such as LMA Protector, one of the most interesting devices for use in
      anaesthetic procedures that are usually performed with SGD.

      Its characteristics in the design, composition by a smooth and atraumatic material, the
      presence of two gastric drainage accesses, with potential improved patient safety and its
      characteristic of being disposable suggests a significant expansion of its use in the coming
      years .

      In contrast to other SGDs that have been evaluated extensively, to date there are no large
      clinical studies showing its suitably and performance in a daily clinical scenario.
observational model: Cohort
time perspective: Prospective
measure: Evaluate the number of attempts to insert of the LMA Protector
time frame: The number of insertion attempts will be collected after anesthesia induction: 1 minute after the administration of propofol
description: Insertion attempts: from picking up the LMA Protector until the mask is placed into the patient mouth . (in numbers)
measure: Blood pressure during insertion of LMA protect
time frame: Baseline and every 3 minutes until 6 minutes after insertion of the LMA protector
description: Blood pressure in mmHg
measure: Heart rate during insertion of LMA protect
time frame: Baseline and every 3 minutes until 6 minutes after insertion of the LMA protector
description: heart rate in beep per minute
measure: BIS data
time frame: Baseline and every 3 minutes until 6 minutes after insertion of the LMA protector (To evaluate the evolution of BIS values during insertion of the LMA
description: number from 100 (awake) to 40-45 (anesthetic status)
measure: Oropharyngeal leak pressure of the LMA Protector
time frame: The Oropharyngeal leak pressure of the LMA Protector will be collected 5 minutes after the LMA Protector will be inserted
description: The Oropharyngeal leak pressure of the LMA Protector 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: Protector Laryngeal Mask Airway
description: Patients undergoing anesthesia in which airway management includes a Protector Laryngeal Mask and fulfill the inclusion criteria of the study.
intervention type: Device
intervention name: Protector Laryngeal Mask airway
description: Evaluate the time of insertion, performance, security and insertion success rate of the Protector Laryngeal Mask in patients under general anasthesia.
arm group label: Protector Laryngeal Mask Airway
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maite López-Gil
role: Study Chair
affiliation: Servicio de Anestesiología, Hospital General Universitario Gregorio Marañon
facility: 
country: Spain
citation: Brimacombe JR, editor. Laryngeal Mask Anesthesia. Principles and practice. 2nd Ed. Filadelfia. 2005.
citation: Van Zundert AA, Skinner MW, Van Zundert TC, Luney SR, Pandit JJ. Value of knowing physical characteristics of the airway device before using it. Br J Anaesth. 2016 Jul;117(1):12-6. doi: 10.1093/bja/aew106. Epub 2016 May 4. No abstract available.
PMID: 27147543
citation: Zaballos García M, López Álvarez S, Agustí Martínez-Marcos S, Blanco Sánchez T, Bustos Molina F, Cabré Fabré P, et al. Nuevas aportaciones de la mascarilla laríngea en cirugía ambulatoria. Contribución de la mascarilla laríngea Supreme. Cir May Amb 2011; 16(2): 60-6.
citation: Zaballos García M, López Álvarez S, Agustí Martínez-Marcos S, Blanco Sánchez T, Bustos Molina F, Cabré Fabré P, Cordero Lorenzo JM, Izquierdo Villaroya B, Lafuente Ojeda N, M. López Gil M, Rodríguez Archilla A, Zaballos Bustingorri J Recomendaciones prácticas de uso de la mascarilla laríngea en Cirugía Ambulatoria. Cir May Amb 2008; 13: (1) 4-26.
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital General Universitario Gregorio Marañon
investigator full name: Matilde Zaballos
investigator title: Anesthesiologist
sharing ipd: No