<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/NCT03251105</url>
  </required_header>
  <id_info>
    <org_study_id>SEEAH/26.04.2016/659</org_study_id>
    <nct_id>NCT03251105</nct_id>
  </id_info>
  <brief_title>Supreme Versus Proseal Laryngeal Mask Airways in Infants</brief_title>
  <official_title>Comparison of the Supreme™ And Proseal™ Laryngeal Mask Airways in Infants: A Prospective Randomised Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sisli Hamidiye Etfal Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sisli Hamidiye Etfal Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      In this study, the Supreme and ProSeal LMAs in infants were compared by measuring their&#xD;
      performance characteristics, including insertion features, ventilation parameters, induced&#xD;
      changes in hemodynamics and rates of postoperative complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Both the Supreme™ and ProSeal™ laryngeal mask airways (LMAs) are widely used for paediatric&#xD;
      anaesthesia; however, LMA use in infants is limited, as many anaesthesiologists prefer to use&#xD;
      tracheal intubation in infants.&#xD;
&#xD;
      In this study, the Supreme and ProSeal LMAs in infants were compared by measuring their&#xD;
      performance characteristics, including insertion features, ventilation parameters, induced&#xD;
      changes in hemodynamics and rates of postoperative complications.&#xD;
&#xD;
      Infants of ASA physical status I who were scheduled for elective, minor, lower abdominal&#xD;
      surgery were divided into two groups: the Supreme LMA group and the ProSeal LMA group. Heart&#xD;
      rate (HR), oxygen saturation and end tidal carbon dioxide values were recorded both before&#xD;
      and after LMA insertion, as well as both before and after extubation. After extubation,&#xD;
      complications and adverse effects were noted.&#xD;
&#xD;
      Demographics and surgical data were similar between the two groups. LMA insertion times for&#xD;
      the ProSeal group were shorter, the leakage pressure for the ProSeal group was statistically&#xD;
      higher. The ProSeal LMA is superior to the Supreme LMA for use in infants, due to its ease of&#xD;
      insertion, high oropharyngeal leakage pressure and fewer induced changes in hemodynamics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 27, 2016</start_date>
  <completion_date type="Actual">January 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Infants, who were scheduled to undergo lower abdominal surgery and to receive anaesthesia</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>performance characteristics</measure>
    <time_frame>operation duration</time_frame>
    <description>insertion time in minutes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>haemodynamics</measure>
    <time_frame>operation duration</time_frame>
    <description>end tidal CO2 (EtCO2) in mmHg</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Surgery</condition>
  <condition>Infant Conditions</condition>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>ProSeal group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group received the ProSeal LMA for supraglottic airway intubation and ventilation during anaesthesia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Supreme group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group received the Supreme LMA for supraglottic airway intubation and ventilation during anaesthesia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>supraglottic airway intubation</intervention_name>
    <arm_group_label>ProSeal group</arm_group_label>
    <arm_group_label>Supreme group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  scheduled for elective, minor (&lt;1 hour duration), lower abdominal surgery, including&#xD;
             unilateral herniorrhaphy and unilateral orchidopexy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  premature birth, potentially difficult airway, clinically significant upper&#xD;
             respiratory tract infection and risk of aspiration, such as gastro-oesophageal reflux&#xD;
             disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sibel Oba, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sisli Hamidiye Etfal Training and Research Hospital</affiliation>
  </overall_official>
  <reference>
    <citation>Luce V, Harkouk H, Brasher C, Michelet D, Hilly J, Maesani M, Diallo T, Mangalsuren N, Nivoche Y, Dahmani S. Supraglottic airway devices vs tracheal intubation in children: a quantitative meta-analysis of respiratory complications. Paediatr Anaesth. 2014 Oct;24(10):1088-98. doi: 10.1111/pan.12495. Epub 2014 Jul 30.</citation>
    <PMID>25074619</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>August 11, 2017</last_update_submitted>
  <last_update_submitted_qc>August 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sisli Hamidiye Etfal Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Canan Tulay ISIL</investigator_full_name>
    <investigator_title>Specialist, M.D.</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We can only share data as Exel or SSPS, but not with patient names.</ipd_description>
  </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/NCT03251105
org study id: SEEAH/26.04.2016/659
nct id: NCT03251105
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this study, the Supreme and ProSeal LMAs in infants were compared by measuring their
      performance characteristics, including insertion features, ventilation parameters, induced
      changes in hemodynamics and rates of postoperative complications.
Both the Supreme™ and ProSeal™ laryngeal mask airways (LMAs) are widely used for paediatric
      anaesthesia; however, LMA use in infants is limited, as many anaesthesiologists prefer to use
      tracheal intubation in infants.

      In this study, the Supreme and ProSeal LMAs in infants were compared by measuring their
      performance characteristics, including insertion features, ventilation parameters, induced
      changes in hemodynamics and rates of postoperative complications.

      Infants of ASA physical status I who were scheduled for elective, minor, lower abdominal
      surgery were divided into two groups: the Supreme LMA group and the ProSeal LMA group. Heart
      rate (HR), oxygen saturation and end tidal carbon dioxide values were recorded both before
      and after LMA insertion, as well as both before and after extubation. After extubation,
      complications and adverse effects were noted.

      Demographics and surgical data were similar between the two groups. LMA insertion times for
      the ProSeal group were shorter, the leakage pressure for the ProSeal group was statistically
      higher. The ProSeal LMA is superior to the Supreme LMA for use in infants, due to its ease of
      insertion, high oropharyngeal leakage pressure and fewer induced changes in hemodynamics.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Infants, who were scheduled to undergo lower abdominal surgery and to receive anaesthesia
primary purpose: Treatment
masking: None (Open Label)
measure: performance characteristics
time frame: operation duration
description: insertion time in minutes
measure: haemodynamics
time frame: operation duration
description: end tidal CO2 (EtCO2) in mmHg
arm group label: ProSeal group
arm group type: Active Comparator
description: This group received the ProSeal LMA for supraglottic airway intubation and ventilation during anaesthesia.
arm group label: Supreme group
arm group type: Active Comparator
description: This group received the Supreme LMA for supraglottic airway intubation and ventilation during anaesthesia.
intervention type: Device
intervention name: supraglottic airway intubation
arm group label: ProSeal group
arm group label: Supreme group
criteria: 
gender: All
minimum age: N/A
maximum age: 12 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Sibel Oba, MD
role: Principal Investigator
affiliation: Sisli Hamidiye Etfal Training and Research Hospital
citation: Luce V, Harkouk H, Brasher C, Michelet D, Hilly J, Maesani M, Diallo T, Mangalsuren N, Nivoche Y, Dahmani S. Supraglottic airway devices vs tracheal intubation in children: a quantitative meta-analysis of respiratory complications. Paediatr Anaesth. 2014 Oct;24(10):1088-98. doi: 10.1111/pan.12495. Epub 2014 Jul 30.
PMID: 25074619
responsible party type: Principal Investigator
investigator affiliation: Sisli Hamidiye Etfal Training and Research Hospital
investigator full name: Canan Tulay ISIL
investigator title: Specialist, M.D.
sharing ipd: No
ipd description: We can only share data as Exel or SSPS, but not with patient names.