<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/NCT03287752</url>
  </required_header>
  <id_info>
    <org_study_id>17100178</org_study_id>
    <nct_id>NCT03287752</nct_id>
  </id_info>
  <brief_title>BASKA Mask Versus Endo Tracheal Tube in Gynecological Laparoscopic Surgery</brief_title>
  <acronym>BASKAMASK</acronym>
  <official_title>A Prospective Randomized Comparison of the Effect of BASKA Mask Versus Endo Tracheal Tube on Respiratory Function Parameters in Patients Undergoing Gynecological Laparoscopic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      The BASKA mask (Logikal Health Products PTY Ltd., Morisset, NSW, Australia) is a novel&#xD;
      supraglottic airway device. It has many of the features of other supraglottic airways, with a&#xD;
      number of innovations. These include; A non-inflatable cuff, that it is continuous with the&#xD;
      central channel of the device. As the pressure increases with positive pressure ventilation,&#xD;
      the cuff itself is 'inflated', this may improve the seal, reduce leak, and make ventilation&#xD;
      more efficient.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The BASKA mask incorporates an inlet that fits into the upper esophagus, and the dorsal&#xD;
      surface of the cuff is moulded to direct any oropharyngeal contents away from the glottis and&#xD;
      towards the side channels to which suction can be attached to facilitate aspiration of this&#xD;
      space (Fig.1c). These features may reduce the risk of pulmonary aspiration of secretions or&#xD;
      gastric contents that accumulate in the supraglottic area.&#xD;
&#xD;
      Compared with previous versions, these modifications have made BASKA mask airway a fairly&#xD;
      safe and effective airway device in low-risk patients undergoing gynecologic laparoscopic&#xD;
      surgeries&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 14, 2017</start_date>
  <completion_date type="Actual">December 29, 2019</completion_date>
  <primary_completion_date type="Actual">December 29, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Peak airway pressure</measure>
    <time_frame>6 hours including preoperative, intraoperative and 4h after operation</time_frame>
    <description>Peak airway pressure before and after abdominal inflation.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">66</enrollment>
  <condition>Ventilation</condition>
  <arm_group>
    <arm_group_label>BASKA MASK</arm_group_label>
    <description>Patients will be anesthetized using BASKA mask after lubrication with water soluble lubricant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endotracheal tube</arm_group_label>
    <description>Patients will be anesthetized using appropriate sized cuffed oral endotracheal tube ETT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BASKA MASK</intervention_name>
    <description>Patients will be anesthetized using BASKA mask after lubrication with water soluble lubricant</description>
    <arm_group_label>BASKA MASK</arm_group_label>
    <other_name>BASKA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endotracheal tube</intervention_name>
    <description>Patients will be anesthetized using appropriate sized cuffed oral endotracheal tube.</description>
    <arm_group_label>Endotracheal tube</arm_group_label>
    <other_name>ETT</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Female patients scheduled for elective gynecological laparoscopic surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Sex: Female patients scheduled for elective gynecological laparoscopic surgery.&#xD;
&#xD;
          -  Age: 18-60 years.&#xD;
&#xD;
          -  BMI&lt; 30kg/m2.&#xD;
&#xD;
          -  ASA physical status: I-II.&#xD;
&#xD;
          -  Operation: gynecological laparoscopic surgery under general anesthesia of an&#xD;
             anticipated duration&lt;1h.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal.&#xD;
&#xD;
          -  History of cardiac disease, psychological disorders, respiratory diseases including&#xD;
             asthma, renal or hepatic failure.&#xD;
&#xD;
          -  Patients who have high risk of regurgitation or aspiration based on history of gastro&#xD;
             esophageal reflux, hiatus hernia, diabetes and gross obesity.&#xD;
&#xD;
          -  Neck pathology.&#xD;
&#xD;
          -  Patients who predicted difficult airway (based on a history of difficult airway, mouth&#xD;
             opening was less than 2.5 cm, inter-incisor distance &lt; 20 mm, cervical spine&#xD;
             pathology, modified Mallampati class III/IV, or thyromental distance &lt; 65 mm).&#xD;
&#xD;
          -  Allergy to any of the anesthetic agents used.&#xD;
&#xD;
          -  The possibility of being pregnant.&#xD;
&#xD;
          -  Heavy smoker.&#xD;
&#xD;
          -  Preoperative sore throat.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>females 18-60years</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hala S Abdelghaffar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>women health hospital, Assiut university</name>
      <address>
        <city>Assiut</city>
        <state>Assiut Governorate</state>
        <zip>715715</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>October 9, 2021</last_update_submitted>
  <last_update_submitted_qc>October 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Hala Saad Abdel-Ghaffar</investigator_full_name>
    <investigator_title>Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.</investigator_title>
  </responsible_party>
  <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/NCT03287752
org study id: 17100178
nct id: NCT03287752
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The BASKA mask (Logikal Health Products PTY Ltd., Morisset, NSW, Australia) is a novel
      supraglottic airway device. It has many of the features of other supraglottic airways, with a
      number of innovations. These include; A non-inflatable cuff, that it is continuous with the
      central channel of the device. As the pressure increases with positive pressure ventilation,
      the cuff itself is 'inflated', this may improve the seal, reduce leak, and make ventilation
      more efficient.
The BASKA mask incorporates an inlet that fits into the upper esophagus, and the dorsal
      surface of the cuff is moulded to direct any oropharyngeal contents away from the glottis and
      towards the side channels to which suction can be attached to facilitate aspiration of this
      space (Fig.1c). These features may reduce the risk of pulmonary aspiration of secretions or
      gastric contents that accumulate in the supraglottic area.

      Compared with previous versions, these modifications have made BASKA mask airway a fairly
      safe and effective airway device in low-risk patients undergoing gynecologic laparoscopic
      surgeries
observational model: Cohort
time perspective: Prospective
measure: Peak airway pressure
time frame: 6 hours including preoperative, intraoperative and 4h after operation
description: Peak airway pressure before and after abdominal inflation.
arm group label: BASKA MASK
description: Patients will be anesthetized using BASKA mask after lubrication with water soluble lubricant.
arm group label: Endotracheal tube
description: Patients will be anesthetized using appropriate sized cuffed oral endotracheal tube ETT.
intervention type: Device
intervention name: BASKA MASK
description: Patients will be anesthetized using BASKA mask after lubrication with water soluble lubricant
arm group label: BASKA MASK
other name: BASKA
intervention type: Device
intervention name: Endotracheal tube
description: Patients will be anesthetized using appropriate sized cuffed oral endotracheal tube.
arm group label: Endotracheal tube
other name: ETT
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: females 18-60years
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Hala S Abdelghaffar, MD
role: Principal Investigator
affiliation: Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Hala Saad Abdel-Ghaffar
investigator title: Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.
sharing ipd: No