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/NCT06041750</url>
    </required_header>
    <id_info>
      <org_study_id>POPCSA</org_study_id>
      <nct_id>NCT06041750</nct_id>
    </id_info>
    <brief_title>Postoperative Pulmonary Complications In Obstructive Sleep Apnea Patients</brief_title>
    <official_title>Predicting Postoperative Pulmonary Complications In Obstructive Sleep Apnea Patients; Multicentre, Prospective, Observational Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cukurova University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Istanbul University - Cerrahpasa (IUC)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Acibadem University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Baskent University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Celal Bayar University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Cukurova 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>
        It is known that perioperative respiratory complications occur more often in obstructive&#xD;
        sleep apnea syndrome (OSAS) patients during general anesthesia. Although there are&#xD;
        prospective RCTs in this area, the need for further and larger studies remains due to the&#xD;
        heterogenity of the results. Moreover, the incidence of postoperative pulmonary complications&#xD;
        in OSAS patients undergoing surgery in Turkey and the predictive factors affecting the&#xD;
        respiratory adverse events are uncertain. Therefore, in this prospective observational cohort&#xD;
        study, it was aimed to determine the incidence of postoperative pulmonary complications and&#xD;
        the predictor factors associated with patient, anesthesia and surgery in surgical patients&#xD;
        with a confirmed or highly suspected OSAS diagnosis undergoing general anesthesia.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 15, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 15, 2024</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>30 Days</target_duration>
    <primary_outcome>
      <measure>postoperative pulmonary complications</measure>
      <time_frame>Postoperative day 1, 2, 7 and 30.</time_frame>
      <description>The rate of postoperative hypoxia (respiratory failure), atelectasis, pulmonary edema /embolus, aspiration, bronchospasm, respiratory infection / pneumonia, pleural effusion, pneumothorax, respiratory arrest will be measured</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Predictive factors</measure>
      <time_frame>Postoperative day 1, 2, 7 and 30.</time_frame>
      <description>Determination of patient, anesthesia and surgery-related predictive factors affecting the development of postoperative pulmonary complications.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non-invasive/invasive mechanical ventilation requirement</measure>
      <time_frame>Postoperative day 1, 2, 7 and 30.</time_frame>
      <description>Determination of the need for non-invasive or invasive mechanical ventilation beyond clinical standards.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intensive care unit admission</measure>
      <time_frame>Postoperative day 1, 2, 7 and 30.</time_frame>
      <description>Intensive care unit admission for respiratory indication</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mortality</measure>
      <time_frame>Postoperative day 30.</time_frame>
      <description>Mortality rate</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Obstructive Sleep Apnea</condition>
    <condition>Postoperative Complications</condition>
    <arm_group>
      <arm_group_label>OSAS patients with postoperative pulmonary complication</arm_group_label>
      <description>American Society of Anesthesiologists (ASA) physical status I-III adult patients age between 18-65 years undergoing elective surgery with general anesthesia and diagnosis of OSAS will be recruited in this study. In this patient group, the incidence of postoperative early-period and long-term pulmonary complications will be investigated.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Elective surgical procedure under general anesthesia</intervention_name>
      <description>The incidence of postoperative pulmonary complications in OSAS patients undergoing elective surgery under general anesthesia will be determined.</description>
      <arm_group_label>OSAS patients with postoperative pulmonary complication</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          ASA status I-III adult patients age between 18-65 years undergoing elective surgery with&#xD;
          general anesthesia and diagnosis of OSAS will be recruited in this study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age: 18-65 years&#xD;
  &#xD;
            2. ASA physical status I-III&#xD;
  &#xD;
            3. Preoperative OSAS diagnosis (with polysomnography or STOP-BANG questionnaire score)&#xD;
  &#xD;
            4. Surgeries performed under general anesthesia&#xD;
  &#xD;
            5. Endotracheal intubation facilitated by neuromuscular blockers&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. ASA physical status IV or V&#xD;
  &#xD;
            2. Planned admission to the ICU after surgery&#xD;
  &#xD;
            3. Cardiac Surgery&#xD;
  &#xD;
            4. Non-operating room anesthesia&#xD;
  &#xD;
            5. Neuromuscular disease&#xD;
  &#xD;
            6. Emergency or re-operational procedure&#xD;
  &#xD;
            7. Laryngectomy&#xD;
  &#xD;
            8. Pneumonectomy&#xD;
  &#xD;
            9. Invasive airway access&#xD;
  &#xD;
           10. Pregnancy&#xD;
  &#xD;
           11. Outpatient surgery&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Çiğdem Tütüncü, Prof. Dr.</last_name>
      <role>Study Director</role>
      <affiliation>İstanbul University, Cerrahpaşa, Faculty of Medicine</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Demet Laflı Tunay, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Çukurova University, Faculty of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Çiğdem Tütüncü, Prof. Dr.</last_name>
      <phone>+905325920584</phone>
      <email>actutuncu@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Demet Laflı Tunay, Dr.</last_name>
      <phone>+905358685831</phone>
      <email>dlafli@yahoo.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Cukurova University</name>
        <address>
          <city>Adana</city>
          <state>Sariçam</state>
          <zip>01100</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cukurova University</investigator_affiliation>
      <investigator_full_name>Demet Laflı Tunay</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>obstructive sleep apnea</keyword>
    <keyword>postoperative pulmonary complications</keyword>
    <keyword>general anesthesia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Apnea</mesh_term>
      <mesh_term>Sleep Apnea Syndromes</mesh_term>
      <mesh_term>Sleep Apnea, Obstructive</mesh_term>
      <mesh_term>Postoperative Complications</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anesthetics</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>All data will be anonymized by the local researcher. Therefore, data collection will be pseudonymous and the patient's name will not appear on any case report form or other study document. All collected data will be kept confidential. This study will be conducted in accordance with the revision of the Declaration of Helsinki (2008). ICH-GCP will be strictly adhered to.</ipd_description>
    </patient_data>
    <!-- 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/NCT06041750
  org study id: POPCSA
  nct id: NCT06041750
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  It is known that perioperative respiratory complications occur more often in obstructive
        sleep apnea syndrome (OSAS) patients during general anesthesia. Although there are
        prospective RCTs in this area, the need for further and larger studies remains due to the
        heterogenity of the results. Moreover, the incidence of postoperative pulmonary complications
        in OSAS patients undergoing surgery in Turkey and the predictive factors affecting the
        respiratory adverse events are uncertain. Therefore, in this prospective observational cohort
        study, it was aimed to determine the incidence of postoperative pulmonary complications and
        the predictor factors associated with patient, anesthesia and surgery in surgical patients
        with a confirmed or highly suspected OSAS diagnosis undergoing general anesthesia.
  observational model: Cohort
  time perspective: Prospective
  measure: postoperative pulmonary complications
  time frame: Postoperative day 1, 2, 7 and 30.
  description: The rate of postoperative hypoxia (respiratory failure), atelectasis, pulmonary edema /embolus, aspiration, bronchospasm, respiratory infection / pneumonia, pleural effusion, pneumothorax, respiratory arrest will be measured
  measure: Predictive factors
  time frame: Postoperative day 1, 2, 7 and 30.
  description: Determination of patient, anesthesia and surgery-related predictive factors affecting the development of postoperative pulmonary complications.
  measure: Non-invasive/invasive mechanical ventilation requirement
  time frame: Postoperative day 1, 2, 7 and 30.
  description: Determination of the need for non-invasive or invasive mechanical ventilation beyond clinical standards.
  measure: Intensive care unit admission
  time frame: Postoperative day 1, 2, 7 and 30.
  description: Intensive care unit admission for respiratory indication
  measure: Mortality
  time frame: Postoperative day 30.
  description: Mortality rate
  arm group label: OSAS patients with postoperative pulmonary complication
  description: American Society of Anesthesiologists (ASA) physical status I-III adult patients age between 18-65 years undergoing elective surgery with general anesthesia and diagnosis of OSAS will be recruited in this study. In this patient group, the incidence of postoperative early-period and long-term pulmonary complications will be investigated.
  intervention type: Procedure
  intervention name: Elective surgical procedure under general anesthesia
  description: The incidence of postoperative pulmonary complications in OSAS patients undergoing elective surgery under general anesthesia will be determined.
  arm group label: OSAS patients with postoperative pulmonary complication
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Çiğdem Tütüncü, Prof. Dr.
  role: Study Director
  affiliation: İstanbul University, Cerrahpaşa, Faculty of Medicine
  last name: Demet Laflı Tunay, Dr.
  role: Principal Investigator
  affiliation: Çukurova University, Faculty of Medicine
  last name: Çiğdem Tütüncü, Prof. Dr.
  phone: +905325920584
  email: actutuncu@gmail.com
  last name: Demet Laflı Tunay, Dr.
  phone: +905358685831
  email: dlafli@yahoo.com
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Cukurova University
  investigator full name: Demet Laflı Tunay
  investigator title: Assistant Professor
  mesh term: Apnea
  mesh term: Sleep Apnea Syndromes
  mesh term: Sleep Apnea, Obstructive
  mesh term: Postoperative Complications
  mesh term: Anesthetics
  sharing ipd: No
  ipd description: All data will be anonymized by the local researcher. Therefore, data collection will be pseudonymous and the patient's name will not appear on any case report form or other study document. All collected data will be kept confidential. This study will be conducted in accordance with the revision of the Declaration of Helsinki (2008). ICH-GCP will be strictly adhered to.