xml: <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/NCT06005701</url>
    </required_header>
    <id_info>
      <org_study_id>23-33-05</org_study_id>
      <nct_id>NCT06005701</nct_id>
    </id_info>
    <brief_title>Mallampati Score for Prediction and Prognosis of Postoperative Mortality and Morbidity and Safety Profiles of Patients Undergoing Laparoscopic Cholecystectomy in Qassim Region</brief_title>
    <official_title>Mallampati Score for Prediction and Prognosis of Postoperative Mortality and Morbidity and Safety Profiles of Patients Undergoing Laparoscopic Cholecystectomy in Qassim Region</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Qassim University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Qassim 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>
        To predict the majority of Mallampati score for the patients in Qassim region who undergoing&#xD;
        Laparoscopic Cholecystectomy Surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A preoperative assessment by anaesthetic staff should include the Mallampati Score, as there&#xD;
        is a direct correlation between the amount of space in the pharynx and the laryngoscopic view&#xD;
        during intubation which has been refined by Cormack and Lehane (1984) Clinical diagnosis one&#xD;
        of most important factor indicating the postoperative complications like Mallampati score. As&#xD;
        the Mallampati class zero per se is not indicating with any difficulty of airway management&#xD;
        unless other airway characteristics indicating to the difficulty. As well as if the&#xD;
        epiglottis may be large and overhanging, it's not common with airway difficulty in Mallampati&#xD;
        class zero airway.&#xD;
  &#xD;
        The Mallampati score idea is to estimate the size of the tongue related to the oral cavity&#xD;
        and the displacement of the tongue by the laryngoscope blade was likely to be easy or&#xD;
        difficult. It also assessed whether the mouth could be opened adequately to permit intubation&#xD;
  &#xD;
        Research objectives To predict the majority of Mallampati score for the patients in Qassim&#xD;
        region who undergoing Laparoscopic Cholecystectomy Surgery.&#xD;
  &#xD;
        Method:&#xD;
  &#xD;
        Observational, Multi hospital, Regional Study&#xD;
  &#xD;
        Inclusion Criteria:&#xD;
  &#xD;
          1. Age: 20 - 50 years&#xD;
  &#xD;
          2. Laparoscopic Cholecystectomy Surgery&#xD;
  &#xD;
          3. Body Mass Index (BMI): ≤ 35&#xD;
  &#xD;
        Exclusion Criteria:&#xD;
  &#xD;
          1. Age Less than 20 years&#xD;
  &#xD;
          2. Age More than 50 years&#xD;
  &#xD;
          3. Body Mass Index (BMI) &gt; 35&#xD;
  &#xD;
        Data management and analysis plan:&#xD;
  &#xD;
        All data will be entered and analyzed using SPSS V28© (IBM Corp., Armonk, NY, USA).&#xD;
        Categorical variables will have expressed as frequencies and percentages, while continuous&#xD;
        variables will have presented as means ± standard deviations (SDs). The chi-squared test will&#xD;
        have used to evaluate demographic and health-related characteristics associated with name of&#xD;
        the clinic as well as type of service provided to the patient. A p-value of less than 0.05&#xD;
        was considered to be statistically significant&#xD;
  &#xD;
        Ethical considerations:&#xD;
  &#xD;
          -  All investigators completed the Bioethics certificate from The National Committee of&#xD;
             Bioethics at King Abdulaziz City for Science and Technology.&#xD;
  &#xD;
          -  All investigators declare there is no conflict of interest.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">January 1, 2022</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Actual">December 30, 2022</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 Year</target_duration>
    <primary_outcome>
      <measure>Surveillance</measure>
      <time_frame>3 months</time_frame>
      <description>predict the majority of Mallampati score for the patients in Qassim region who undergoing Laparoscopic Cholecystectomy Surgery.</description>
    </primary_outcome>
    <enrollment type="Actual">470</enrollment>
    <condition>Mallampati Score</condition>
    <condition>Difficult Intubation</condition>
    <condition>Patient Satisfaction</condition>
    <condition>Cholestasis</condition>
    <condition>Cholecystitis</condition>
    <eligibility>
      <study_pop>
        <textblock>
          All patients underwent or planned for Laparoscopic Cholecystectomy&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age: 20 - 50 years&#xD;
  &#xD;
            2. Laparoscopic Cholecystectomy Surgery&#xD;
  &#xD;
            3. Body Mass Index (BMI): ≤ 35&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Age Less than 20 years&#xD;
  &#xD;
            2. Age More than 50 years&#xD;
  &#xD;
            3. Body Mass Index (BMI) &gt; 35&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>Qassim University Medical City</name>
        <address>
          <city>Buraidah</city>
          <state>Qassim</state>
          <zip>51411</zip>
          <country>Saudi Arabia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Saudi Arabia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Qassim University</investigator_affiliation>
      <investigator_full_name>Mohammed Abaalkhayl</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Mallampati Score</keyword>
    <keyword>Surgery</keyword>
    <keyword>Anesthesia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cholecystitis</mesh_term>
      <mesh_term>Cholestasis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06005701
  org study id: 23-33-05
  nct id: NCT06005701
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To predict the majority of Mallampati score for the patients in Qassim region who undergoing
        Laparoscopic Cholecystectomy Surgery.
  A preoperative assessment by anaesthetic staff should include the Mallampati Score, as there
        is a direct correlation between the amount of space in the pharynx and the laryngoscopic view
        during intubation which has been refined by Cormack and Lehane (1984) Clinical diagnosis one
        of most important factor indicating the postoperative complications like Mallampati score. As
        the Mallampati class zero per se is not indicating with any difficulty of airway management
        unless other airway characteristics indicating to the difficulty. As well as if the
        epiglottis may be large and overhanging, it's not common with airway difficulty in Mallampati
        class zero airway.
  
        The Mallampati score idea is to estimate the size of the tongue related to the oral cavity
        and the displacement of the tongue by the laryngoscope blade was likely to be easy or
        difficult. It also assessed whether the mouth could be opened adequately to permit intubation
  
        Research objectives To predict the majority of Mallampati score for the patients in Qassim
        region who undergoing Laparoscopic Cholecystectomy Surgery.
  
        Method:
  
        Observational, Multi hospital, Regional Study
  
        Inclusion Criteria:
  
          1. Age: 20 - 50 years
  
          2. Laparoscopic Cholecystectomy Surgery
  
          3. Body Mass Index (BMI): ≤ 35
  
        Exclusion Criteria:
  
          1. Age Less than 20 years
  
          2. Age More than 50 years
  
          3. Body Mass Index (BMI) > 35
  
        Data management and analysis plan:
  
        All data will be entered and analyzed using SPSS V28© (IBM Corp., Armonk, NY, USA).
        Categorical variables will have expressed as frequencies and percentages, while continuous
        variables will have presented as means ± standard deviations (SDs). The chi-squared test will
        have used to evaluate demographic and health-related characteristics associated with name of
        the clinic as well as type of service provided to the patient. A p-value of less than 0.05
        was considered to be statistically significant
  
        Ethical considerations:
  
          -  All investigators completed the Bioethics certificate from The National Committee of
             Bioethics at King Abdulaziz City for Science and Technology.
  
          -  All investigators declare there is no conflict of interest.
  observational model: Cohort
  time perspective: Prospective
  measure: Surveillance
  time frame: 3 months
  description: predict the majority of Mallampati score for the patients in Qassim region who undergoing Laparoscopic Cholecystectomy Surgery.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 50 Years
  facility: 
  country: Saudi Arabia
  responsible party type: Principal Investigator
  investigator affiliation: Qassim University
  investigator full name: Mohammed Abaalkhayl
  investigator title: Assistant Professor
  mesh term: Cholecystitis
  mesh term: Cholestasis