<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/NCT03812081</url>
  </required_header>
  <id_info>
    <org_study_id>N_50_2018</org_study_id>
    <nct_id>NCT03812081</nct_id>
  </id_info>
  <brief_title>A Comparative Study of the Baska Mask Vs Proseal Laryngeal Mask Regarding Airway Sealing Pressure</brief_title>
  <official_title>A Comparative Study of the Baska Mask Vs Proseal Laryngeal Mask Regarding Airway Sealing Pressure According to Confirmation by Fiberoptic Position</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Baska mask air way(BM) in comparative study with Proseal laryngeal mask airway (PLMA)&#xD;
      regarding performance of Baska mask improves the safety and efficacy of airway management for&#xD;
      in patients undergoing general anesthesia by mechanical ventilation confirmation of position&#xD;
      by fiber optic view of glottis opening and success of gastric tube insertion , Airway sealing&#xD;
      pressure, Leak fraction, insertion time and &quot;overall insertion&quot; success rates, and&#xD;
      post-operative complications (airway trauma, hoarseness, sore throat and Dysphagia ).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Maintenance of a patent airway is a major responsibility for the anesthesiologists,&#xD;
      interruption of gas exchange, even for a few minutes, can result in catastrophic outcomes&#xD;
      such as brain damage or death.&#xD;
&#xD;
      Supraglottic airway devices are devices that ventilate patients by delivering anaesthetic&#xD;
      gases/oxygen above the level of the vocal cord. Since the development of the laryngeal mask&#xD;
      airway, many other supraglottic devices have been introduced in the clinical practice of&#xD;
      airway management, trying to offer a simple and effective alternative to endotracheal tube.&#xD;
&#xD;
      However, following experience with such simple cases, clinicians soon become comfortable with&#xD;
      more complex cases, such as cases of longer duration, cases with sicker patient reported&#xD;
      favorable outcomes in safety profile, risk, ease of insertion, recovery of patients and cost&#xD;
      analyses. However, there is an under reporting of complications aris¬ing during ventilation&#xD;
      with this device and the risk factors associated with such complications in adult patients.&#xD;
      These include Hypoxia, laryngospasm, and difficulty with insertion, suboptimal ventilation,&#xD;
      bronchospasm, aspiration, desaturation, hy¬potension and conversion to intubation with ETT.&#xD;
      These can be significantly serious and life threatening&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2018</start_date>
  <completion_date type="Actual">February 7, 2019</completion_date>
  <primary_completion_date type="Actual">February 5, 2019</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>Following approval from EL Kasr Al-Ainy teaching hospital ethical committee and an informed patient consent, the investigators enrolled 74adult patients ASA I and II, non-obese (BMI&lt;30) ranging from18-45 yrs. of age, Patients underwent a variety of elective surgical procedures in the supine position with SAD placement for ≤ 2 hours duration. Patients randomly divided by computer designed lists and then concealed in closed envelopes into 2 equal groups:&#xD;
Group A (n= 37), in which Baska Mask Airway _ (size 3,4,5) will used for ventilation according of patient body weight.&#xD;
Group B (n= 37), in which Laryngeal Mask Airway- Proseal LMA_ (size 3,4,5) was used for ventilation according of patient body weight.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>72 Patients are randomly divided by computer designed lists and then concealed in closed envelopes into 2 equal groups: Group A (n= 37), in which Baska Mask Airway _ (size 3,4,5) will used for ventilation according of patient body weight.&#xD;
Group B (n= 37), in which Laryngeal Mask Airway- Proseal LMA_ (size 3,4,5) was used for ventilation according of patient body weight</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Airway sealing pressure in cmH2O</measure>
    <time_frame>15 Minutes</time_frame>
    <description>The airway sealing pressure is the pressure at which leak starts; in cmH2O at 5 mints post placement, this leak pressure will calculate as the plateau airway pressure reach with fresh gas flow 6 l/min, and pressure adjustment valve set at 70 cmH2O, and observing of the rise of the ventilator's airway pressure.&#xD;
A ''puffing'' sound was heard near the patient's mouth (release of pressure) indicating the airway seal pressure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Laryngeal view grades recorded by fiberoptic bronchoscopes.</measure>
    <time_frame>15 Minutes</time_frame>
    <description>fiberoptic bronchoscopes can record Laryngeal view grades</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device Complications:</measure>
    <time_frame>Through study completion</time_frame>
    <description>Patients will be monitoring for the following complications: arterial oxygen desaturation, lip damage; blood staining on mask removal and laryngospasm, the incidence and severity of throat pain, dysphagia, Heart burn, Nausea and Vomiting at arrival and discharge from the recovery unit and on the first postoperative day</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Baska Mask</condition>
  <arm_group>
    <arm_group_label>Group A Baska Mask</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In which Baska Mask Airway (size 3,4,5) will used for ventilation according of patient body weight.Size selection is based on the manufacturer's recommendation of weight-based estimate plus clinical judgment. The Baska Mask is available in four sizes: size three (30 to 50 kg), size four (50 to 70 kg), size five (70 to 100 kg),The membranous cuff of the Baska Mask appears bulkier than the equivalent inflatable cuff on cuffed laryngeal masks. The mask can easily be decreased in size during insertion by compressing the proximal, firmer part of the mask below the airway tube, between the thumb and two fingers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B Proseal Mask</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In which Laryngeal Mask Airway- Proseal LMA (size 3,4,5) was used for ventilation according of patient body weight.Size selection is based on the manufacturer's recommendation of weight-based estimate plus clinical judgment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Group A : Baska Mask Airway</intervention_name>
    <description>Size selection is based on the manufacturer's recommendation of weight-based estimate plus clinical judgment. The Baska Mask is available in four sizes: size three (30 to 50 kg), size four (50 to 70 kg), size five (70 to 100 kg),The membranous cuff of the Baska Mask appears bulkier than the equivalent inflatable cuff on cuffed laryngeal masks. The mask can easily be decreased in size during insertion by compressing the proximal, firmer part of the mask below the airway tube, between the thumb and two fingers</description>
    <arm_group_label>Group A Baska Mask</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Group B: Proseal Laryngeal Mask Airway</intervention_name>
    <description>Proseal LMA (size 3,4,5) was used for ventilation according of patient body weight.Size selection is based on the manufacturer's recommendation of weight-based estimate plus clinical judgment.</description>
    <arm_group_label>Group B Proseal Mask</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy adult ASA I-II patients,&#xD;
&#xD;
          2. Both genders, aged 18-45 years,&#xD;
&#xD;
          3. Body weight between 50 and 90 kg who BMI &gt; 30 kg/m2&#xD;
&#xD;
          4. Non-urgent surgery of planned duration up to 2 hrs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient refusal&#xD;
&#xD;
          2. Patients having known tendency to nausea/vomiting or pharyngeal pathology&#xD;
&#xD;
          3. Morbid obese patients with body mass index &gt;30 kg/m2&#xD;
&#xD;
          4. Patients known to have gastro-esophageal reflux disease (GERD), hiatus hernia or&#xD;
             previous upper gastrointestinal tract surgery&#xD;
&#xD;
          5. History of difficult intubation, measured the common predictive indices for difficult&#xD;
             intubation (BMI, thyromental distance,Mallampati grade, inter-incisor distance,&#xD;
             dentition and neck movement ).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ahmed Abdalla Mohamed</name>
      <address>
        <city>Cairo</city>
        <zip>11451</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>February 18, 2019</last_update_submitted>
  <last_update_submitted_qc>February 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Abdalla</investigator_full_name>
    <investigator_title>Professor of Anesthesia &amp;I.C.U and Pain Clinic, Cairo University</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Till Press</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/NCT03812081
org study id: N_50_2018
nct id: NCT03812081
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Baska mask air way(BM) in comparative study with Proseal laryngeal mask airway (PLMA)
      regarding performance of Baska mask improves the safety and efficacy of airway management for
      in patients undergoing general anesthesia by mechanical ventilation confirmation of position
      by fiber optic view of glottis opening and success of gastric tube insertion , Airway sealing
      pressure, Leak fraction, insertion time and "overall insertion" success rates, and
      post-operative complications (airway trauma, hoarseness, sore throat and Dysphagia ).
Maintenance of a patent airway is a major responsibility for the anesthesiologists,
      interruption of gas exchange, even for a few minutes, can result in catastrophic outcomes
      such as brain damage or death.

      Supraglottic airway devices are devices that ventilate patients by delivering anaesthetic
      gases/oxygen above the level of the vocal cord. Since the development of the laryngeal mask
      airway, many other supraglottic devices have been introduced in the clinical practice of
      airway management, trying to offer a simple and effective alternative to endotracheal tube.

      However, following experience with such simple cases, clinicians soon become comfortable with
      more complex cases, such as cases of longer duration, cases with sicker patient reported
      favorable outcomes in safety profile, risk, ease of insertion, recovery of patients and cost
      analyses. However, there is an under reporting of complications aris¬ing during ventilation
      with this device and the risk factors associated with such complications in adult patients.
      These include Hypoxia, laryngospasm, and difficulty with insertion, suboptimal ventilation,
      bronchospasm, aspiration, desaturation, hy¬potension and conversion to intubation with ETT.
      These can be significantly serious and life threatening
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Following approval from EL Kasr Al-Ainy teaching hospital ethical committee and an informed patient consent, the investigators enrolled 74adult patients ASA I and II, non-obese (BMI<30) ranging from18-45 yrs. of age, Patients underwent a variety of elective surgical procedures in the supine position with SAD placement for ≤ 2 hours duration. Patients randomly divided by computer designed lists and then concealed in closed envelopes into 2 equal groups:
Group A (n= 37), in which Baska Mask Airway _ (size 3,4,5) will used for ventilation according of patient body weight.
Group B (n= 37), in which Laryngeal Mask Airway- Proseal LMA_ (size 3,4,5) was used for ventilation according of patient body weight.
primary purpose: Diagnostic
masking: Double (Participant, Care Provider)
masking description: 72 Patients are randomly divided by computer designed lists and then concealed in closed envelopes into 2 equal groups: Group A (n= 37), in which Baska Mask Airway _ (size 3,4,5) will used for ventilation according of patient body weight.
Group B (n= 37), in which Laryngeal Mask Airway- Proseal LMA_ (size 3,4,5) was used for ventilation according of patient body weight
measure: Airway sealing pressure in cmH2O
time frame: 15 Minutes
description: The airway sealing pressure is the pressure at which leak starts; in cmH2O at 5 mints post placement, this leak pressure will calculate as the plateau airway pressure reach with fresh gas flow 6 l/min, and pressure adjustment valve set at 70 cmH2O, and observing of the rise of the ventilator's airway pressure.
A ''puffing'' sound was heard near the patient's mouth (release of pressure) indicating the airway seal pressure
measure: Laryngeal view grades recorded by fiberoptic bronchoscopes.
time frame: 15 Minutes
description: fiberoptic bronchoscopes can record Laryngeal view grades
measure: Device Complications:
time frame: Through study completion
description: Patients will be monitoring for the following complications: arterial oxygen desaturation, lip damage; blood staining on mask removal and laryngospasm, the incidence and severity of throat pain, dysphagia, Heart burn, Nausea and Vomiting at arrival and discharge from the recovery unit and on the first postoperative day
arm group label: Group A Baska Mask
arm group type: Active Comparator
description: In which Baska Mask Airway (size 3,4,5) will used for ventilation according of patient body weight.Size selection is based on the manufacturer's recommendation of weight-based estimate plus clinical judgment. The Baska Mask is available in four sizes: size three (30 to 50 kg), size four (50 to 70 kg), size five (70 to 100 kg),The membranous cuff of the Baska Mask appears bulkier than the equivalent inflatable cuff on cuffed laryngeal masks. The mask can easily be decreased in size during insertion by compressing the proximal, firmer part of the mask below the airway tube, between the thumb and two fingers
arm group label: Group B Proseal Mask
arm group type: Active Comparator
description: In which Laryngeal Mask Airway- Proseal LMA (size 3,4,5) was used for ventilation according of patient body weight.Size selection is based on the manufacturer's recommendation of weight-based estimate plus clinical judgment.
intervention type: Device
intervention name: Group A : Baska Mask Airway
description: Size selection is based on the manufacturer's recommendation of weight-based estimate plus clinical judgment. The Baska Mask is available in four sizes: size three (30 to 50 kg), size four (50 to 70 kg), size five (70 to 100 kg),The membranous cuff of the Baska Mask appears bulkier than the equivalent inflatable cuff on cuffed laryngeal masks. The mask can easily be decreased in size during insertion by compressing the proximal, firmer part of the mask below the airway tube, between the thumb and two fingers
arm group label: Group A Baska Mask
intervention type: Device
intervention name: Group B: Proseal Laryngeal Mask Airway
description: Proseal LMA (size 3,4,5) was used for ventilation according of patient body weight.Size selection is based on the manufacturer's recommendation of weight-based estimate plus clinical judgment.
arm group label: Group B Proseal Mask
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Abdalla
investigator title: Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University
sharing ipd: Undecided
ipd description: Till Press