<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/NCT03828513</url>
  </required_header>
  <id_info>
    <org_study_id>KIA 2018/174</org_study_id>
    <nct_id>NCT03828513</nct_id>
  </id_info>
  <brief_title>Can the Effects of High Flow Nasal Cannula Oxygenation on Postoperative Atelectasis be Evaluated With Lung Ultrasound</brief_title>
  <official_title>Can the Effects of High Flow Nasal Cannula Oxygenation on Postoperative Atelectasis be Evaluated With Lung Ultrasound: A Randomized Controlled Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kocaeli Derince Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kocaeli Derince Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      Evaluate the effects of high-flow nasal oxygen therapy on atelectasis in the perioperative&#xD;
      period by lung ultrasound (LUS) in bariatric surgery patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In obese patients, lung compliance decreases by 25% and Functional Residual Capacity&#xD;
      decreases by about one-third. As they consume about 25% more oxygen than non-obese&#xD;
      individuals, postoperative pulmonary complications occur more commonly. POINT (Peri-Operative&#xD;
      Insufflatory Nasal Therapy) provides humidified and heated high flow oxygen therapy in&#xD;
      perioperative period. High-ﬂow nasal oxygen (HFNO) facilitates oxygenation and ventilation of&#xD;
      both the spontaneously breathing and apnoeic patient.High-ﬂow nasal cannula oxygen came to&#xD;
      prominence in anaesthesia when it was shown to prolong the time to oxygen desaturation in&#xD;
      patients with a difﬁcult airway.&#xD;
&#xD;
      Lung ultrasonography (LUS) has been used more frequently in the diagnosis of pulmonary&#xD;
      pathologies than chest radiography. This prospective observational study is to evaluate the&#xD;
      effects of high-flow nasal oxygen therapy on atelectasis in the perioperative period by lung&#xD;
      ultrasound (LUS) in bariatric surgery patients.&#xD;
&#xD;
      Materials and Methods: Following the Ethics Committee approval and written informe consents,&#xD;
      100 adult bariatric surgery patients are include in this observational study. The patients&#xD;
      are randomly distributed into two groups ; High Flow Nasal Cannula Oxygenation(HFNCO) made&#xD;
      group(n:50); HFNCO not made group(n:50).&#xD;
&#xD;
      HFNCO is start at a flow rate of 20 L/min with 100% oxygen in the preoperative period. It is&#xD;
      titrate up to 50 L/min and increase to 80 L/min under general anesthesia until tracheal&#xD;
      intubation. Atelectasis evaluation with lung ultrasound is performe and score in 6 different&#xD;
      areas before and after HFNCO.&#xD;
&#xD;
      Pulmonary function tests and blood gas parameters are compared.During the procedure, the&#xD;
      patient's blood pressure, heart rate, oxygen saturation, any complications that may develop&#xD;
      will be recorded.nduction of anesthesia; difficult airway management, difficult mask and / or&#xD;
      difficult intubation incidence, Mallampati scores, the use of one of the difficult intubation&#xD;
      techniques during intubation (such as FastTrack, videolaryngoscopy or fiberoptic intubation),&#xD;
      perioperative mechanical ventilation parameters (ventilation mode, tidal volume, respiratory&#xD;
      frequency, end of tidal CO2 (carbon dioxide) pressure, PEEP usage, SpO2 (saturation oxygen),&#xD;
      airway peak pressure, urine volume, arterial blood gas parameters are recorded.Duration of&#xD;
      operation, surgical method (laparotomy / laparoscopy), agents used in induction and&#xD;
      postoperative analgesia, use of blood, blood product and vasopressor are recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Anticipated">October 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2023</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>
    <primary_purpose>Screening</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of postoperative atelectasis in bariatric surgery patients</measure>
    <time_frame>Up to 20 minutes in postoperative care unit</time_frame>
    <description>Postoperative atelectasis develops in patients undergoing laparoscopic bariatric surgery under anesthesia.After the operation a researcher will perform lung ultrasonography postoperative at minute 5. reseracher will detect 6 region of each lung totally 12 regions. the researcher will record the modified and original lung ultrasonography scores (LUS score) of the patients. LUS Score is a scoring system to eveluate atelectasis of lung and scores 1-3 points for each region (min score 0 max score 36)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Postoperative Atelectasis</condition>
  <condition>Bariatric Surgery Candidate</condition>
  <condition>Ultrasound Therapy; Complications</condition>
  <arm_group>
    <arm_group_label>High flow nasal cannula oxygen applied</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>High flow nasal cannula oxygen is start at a flow rate of 80 L/min with 100% oxygen in the preoperative period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High flow nasal cannula oxygen is not applied</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Preoxygenation will be applied with an oxygen supplement of 5 l/min to an endtidal O2&gt; 90%.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High flow nasal cannula oxygen is applied</intervention_name>
    <description>Atelectasis evaluation with lung ultrasound is performe and score in 6 different areas before and after High flow nasal cannula oxygen. Pulmonary function tests and blood gas parameters are compared.During the procedure, the patient's blood pressure, heart rate, oxygen saturation, any complications that may develop will be recorded.Induction of anesthesia; difficult airway management, difficult mask and / or difficult intubation incidence, Mallampati scores, the use of one of the difficult intubation techniques during intubation, perioperative mechanical ventilation parameters (ventilation mode, tidal volume, respiratory frequency, end of tidal CO2 (carbon dioxide) pressure, PEEP usage, SpO2 (saturation oxygen), airway peak pressure, urine volume, arterial blood gas parameters are recorded.</description>
    <arm_group_label>High flow nasal cannula oxygen applied</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High flow nasal cannula oxygen is not applied</intervention_name>
    <description>Apply preoxygenation with facemask. Prior to induction of general anesthesia, preoxygenation will be applied with an oxygen supplement of 5 l / min to an endtidal O2&gt; 90%.Atelectasis evaluation with lung ultrasound is performe and score in 6 different areas before and after preoxygenation.</description>
    <arm_group_label>High flow nasal cannula oxygen is not applied</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Above 18 years;&#xD;
&#xD;
          2. Patients who have undergone obesity surgery;&#xD;
&#xD;
          3. ASA 2-3 patients;&#xD;
&#xD;
          4. Patients who have received written informed consent;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients under the age of 18;&#xD;
&#xD;
          2. Patients refusing to participate in the study;&#xD;
&#xD;
          3. Patients under emergency conditions;&#xD;
&#xD;
          4. Earlier laryngeal and tracheal surgery;&#xD;
&#xD;
          5. allergies to lidocaine;&#xD;
&#xD;
          6. Patients with FEV1 / FVC below 60%&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>18 Years to 80 Years (Adult, Older Adult)</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emine Yurt, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Investigator</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kocaeli Derince Education and Research Hospital</name>
      <address>
        <city>Kocaeli</city>
        <state>Derince</state>
        <zip>41400</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 22, 2018</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>January 16, 2023</last_update_submitted>
  <last_update_submitted_qc>January 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kocaeli Derince Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>EMİNE YURT</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Atelectasis</mesh_term>
  </condition_browse>
  <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/NCT03828513
org study id: KIA 2018/174
nct id: NCT03828513
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluate the effects of high-flow nasal oxygen therapy on atelectasis in the perioperative
      period by lung ultrasound (LUS) in bariatric surgery patients.
In obese patients, lung compliance decreases by 25% and Functional Residual Capacity
      decreases by about one-third. As they consume about 25% more oxygen than non-obese
      individuals, postoperative pulmonary complications occur more commonly. POINT (Peri-Operative
      Insufflatory Nasal Therapy) provides humidified and heated high flow oxygen therapy in
      perioperative period. High-ﬂow nasal oxygen (HFNO) facilitates oxygenation and ventilation of
      both the spontaneously breathing and apnoeic patient.High-ﬂow nasal cannula oxygen came to
      prominence in anaesthesia when it was shown to prolong the time to oxygen desaturation in
      patients with a difﬁcult airway.

      Lung ultrasonography (LUS) has been used more frequently in the diagnosis of pulmonary
      pathologies than chest radiography. This prospective observational study is to evaluate the
      effects of high-flow nasal oxygen therapy on atelectasis in the perioperative period by lung
      ultrasound (LUS) in bariatric surgery patients.

      Materials and Methods: Following the Ethics Committee approval and written informe consents,
      100 adult bariatric surgery patients are include in this observational study. The patients
      are randomly distributed into two groups ; High Flow Nasal Cannula Oxygenation(HFNCO) made
      group(n:50); HFNCO not made group(n:50).

      HFNCO is start at a flow rate of 20 L/min with 100% oxygen in the preoperative period. It is
      titrate up to 50 L/min and increase to 80 L/min under general anesthesia until tracheal
      intubation. Atelectasis evaluation with lung ultrasound is performe and score in 6 different
      areas before and after HFNCO.

      Pulmonary function tests and blood gas parameters are compared.During the procedure, the
      patient's blood pressure, heart rate, oxygen saturation, any complications that may develop
      will be recorded.nduction of anesthesia; difficult airway management, difficult mask and / or
      difficult intubation incidence, Mallampati scores, the use of one of the difficult intubation
      techniques during intubation (such as FastTrack, videolaryngoscopy or fiberoptic intubation),
      perioperative mechanical ventilation parameters (ventilation mode, tidal volume, respiratory
      frequency, end of tidal CO2 (carbon dioxide) pressure, PEEP usage, SpO2 (saturation oxygen),
      airway peak pressure, urine volume, arterial blood gas parameters are recorded.Duration of
      operation, surgical method (laparotomy / laparoscopy), agents used in induction and
      postoperative analgesia, use of blood, blood product and vasopressor are recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Participant)
measure: Evaluation of postoperative atelectasis in bariatric surgery patients
time frame: Up to 20 minutes in postoperative care unit
description: Postoperative atelectasis develops in patients undergoing laparoscopic bariatric surgery under anesthesia.After the operation a researcher will perform lung ultrasonography postoperative at minute 5. reseracher will detect 6 region of each lung totally 12 regions. the researcher will record the modified and original lung ultrasonography scores (LUS score) of the patients. LUS Score is a scoring system to eveluate atelectasis of lung and scores 1-3 points for each region (min score 0 max score 36)
arm group label: High flow nasal cannula oxygen applied
arm group type: Active Comparator
description: High flow nasal cannula oxygen is start at a flow rate of 80 L/min with 100% oxygen in the preoperative period.
arm group label: High flow nasal cannula oxygen is not applied
arm group type: Active Comparator
description: Preoxygenation will be applied with an oxygen supplement of 5 l/min to an endtidal O2> 90%.
intervention type: Device
intervention name: High flow nasal cannula oxygen is applied
description: Atelectasis evaluation with lung ultrasound is performe and score in 6 different areas before and after High flow nasal cannula oxygen. Pulmonary function tests and blood gas parameters are compared.During the procedure, the patient's blood pressure, heart rate, oxygen saturation, any complications that may develop will be recorded.Induction of anesthesia; difficult airway management, difficult mask and / or difficult intubation incidence, Mallampati scores, the use of one of the difficult intubation techniques during intubation, perioperative mechanical ventilation parameters (ventilation mode, tidal volume, respiratory frequency, end of tidal CO2 (carbon dioxide) pressure, PEEP usage, SpO2 (saturation oxygen), airway peak pressure, urine volume, arterial blood gas parameters are recorded.
arm group label: High flow nasal cannula oxygen applied
intervention type: Device
intervention name: High flow nasal cannula oxygen is not applied
description: Apply preoxygenation with facemask. Prior to induction of general anesthesia, preoxygenation will be applied with an oxygen supplement of 5 l / min to an endtidal O2> 90%.Atelectasis evaluation with lung ultrasound is performe and score in 6 different areas before and after preoxygenation.
arm group label: High flow nasal cannula oxygen is not applied
criteria: 
gender: All
gender based: Yes
gender description: 18 Years to 80 Years (Adult, Older Adult)
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Emine Yurt, doctor
role: Principal Investigator
affiliation: Investigator
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kocaeli Derince Education and Research Hospital
investigator full name: EMİNE YURT
investigator title: Principal Investigator
mesh term: Pulmonary Atelectasis
sharing ipd: No