<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/NCT03296449</url>
  </required_header>
  <id_info>
    <org_study_id>FREQUENCY</org_study_id>
    <nct_id>NCT03296449</nct_id>
  </id_info>
  <brief_title>Comparison Between CPAP and HFJV During One-lung Ventilation in VATS</brief_title>
  <official_title>Comparison Between Continuous Positive Airway Pressure and High-frequency Jet Ventilation in Nondependent Lung During One-lung Ventilation in Video-assisted Thoracoscopic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital General Universitario de Alicante</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital General Universitario de Alicante</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares two ventilatory techniques (continuous positive airway pressure vs high&#xD;
      frequency jet ventilation) during one-lung ventilation (OLV) in video-assisted thoracic&#xD;
      surgery (VATS). All patients were ventilated with both ventilatory techniques and parameters&#xD;
      of gas exchange were determined through arterial blood gas test.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One-lung ventilation is mandatory during most thoracic surgery procedures. During OLV,&#xD;
      collapsed lung develops an intrapulmonary shunt leading to arterial hypoxemia. Since arterial&#xD;
      hypoxemia is a critical intraoperative problem, many times , anesthesiologists have to use&#xD;
      rescue ventilation strategies on non-dependent lung to improve arterial oxygen levels. The&#xD;
      use of continuous positive airway pressure on non-dependent lung has become the most common&#xD;
      technique to achieve that aim.&#xD;
&#xD;
      High-frequency jet ventilation on non-dependent lung may be considered as an alternative way&#xD;
      of ventilation of the non-dependent lung during one-lung ventilation because it provides a&#xD;
      suitable gaseous exchange while facilitating minimizing surgical field motion. However, this&#xD;
      ventilation maneuver is rarely use by thoracic anesthesiologists.&#xD;
&#xD;
      Over the last years, video assisted thoracic surgery (VATS) has become widely utilized. This&#xD;
      surgical technique becomes even more dependent on immobilization of the operation field than&#xD;
      open-chest thoracic procedures. There is a lack of evidence in the current literature&#xD;
      regarding the use of HFJV in VATS.&#xD;
&#xD;
      The purpose of this study is to evaluate the effects of HFJV as an alternative for the&#xD;
      treatment of hypoxemia in VATS.&#xD;
&#xD;
      One-lung ventilation is mandatory during most thoracic surgery procedures. During OLV,&#xD;
      collapsed lung develops an intrapulmonary shunt leading to arterial hypoxemia. Since arterial&#xD;
      hypoxemia is a critical intraoperative problem, many times , anesthesiologists have to use&#xD;
      rescue ventilation strategies on non-dependent lung to improve arterial oxygen levels. The&#xD;
      use of continuous positive airway pressure on non-dependent lung has become the most common&#xD;
      technique to achieve that aim.&#xD;
&#xD;
      High-frequency jet ventilation on non-dependent lung may be considered as an alternative way&#xD;
      of ventilation of the non-dependent lung during one-lung ventilation because provide suitable&#xD;
      gaseous exchange while facilitate minimizing surgical field motion. However , this&#xD;
      ventilation maneuver is rarely use by thoracic anesthesiologists.&#xD;
&#xD;
      Over the last years, video assisted thoracic surgery (VATS) has become widely utilized. This&#xD;
      surgical technique becomes even more dependent on immobilization of the operation field than&#xD;
      open-chest thoracic procedures. There is a lack of evidence in the current literature about&#xD;
      the use of HFJV in VATS.&#xD;
&#xD;
      The purpose of this study is to evaluate the effects of HFJV as an alternative for the&#xD;
      treatment of hypoxemia in VATS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 22, 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">April 29, 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PaO2/FiO2</measure>
    <time_frame>1 day</time_frame>
    <description>Ratio of the arterial oxygen partial pressure (PaO2) to the inspired oxygen fraction (FiO2) determination.&#xD;
Time 0 (the patient is anesthetized and being ventilated on two lungs). Time 20 minutes (patient has been ventilated on one lung for 20 minutes). Time 40 minutes (following a period of 20 minutes on one intervention arm [either CPAP or HFJV]. The patient will then enter second intervention arm). Time 60 minutes ( 20 minutes after second intervention arm [either CPAP or HFJV])</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PaCO2</measure>
    <time_frame>1 day</time_frame>
    <description>Arterial carbon dioxide partial pressure determination. Time 0 (the patient is anesthetized and being ventilated on two lungs). Time 20 minutes (patient has been ventilated on one lung for 20 minutes). Time 40 minutes (following a period of 20 minutes on one intervention arm [either CPAP or HFJV]. The patient will then enter second intervention arm). Time 60 minutes ( 20 minutes after second intervention arm [either CPAP or HFJV])</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative field conditions</measure>
    <time_frame>1 day</time_frame>
    <description>Surgeon's subjective opinion about operating conditions during the interventions: impossible surgical access, acceptable operative filed or excellent operative field).&#xD;
Time 20 minutes (patient has been ventilated on one lung for 20 minutes). Time 40 minutes (following a period of 20 minutes on one intervention arm [either CPAP or HFJV]. The patient will then enter second intervention arm). Time 60 minutes ( 20 minutes after second intervention arm [either CPAP or HFJV])</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Airway pressures</measure>
    <time_frame>1 day</time_frame>
    <description>Recording during mechanical ventilation of dependent lung airway pressures. Time 0 (the patient is anesthetized and being ventilated on two lungs). Time 20 minutes (patient has been ventilated on one lung for 20 minutes). Time 40 minutes (following a period of 20 minutes on one intervention arm [either CPAP or HFJV]. The patient will then enter second intervention arm). Time 60 minutes ( 20 minutes after second intervention arm [either CPAP or HFJV])</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse effects and complication</measure>
    <time_frame>30 days</time_frame>
    <description>Any complication or adverse effect arising from ventilation techniques: need of intensive care unit admissions, re-intervention, or thoracotomy, surgical site infection, anastomosis leakage, and pneumonia.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hemodynamic parameters</measure>
    <time_frame>1 day</time_frame>
    <description>Heart rate and mean arterial blood pressure. Time 0 (the patient is anesthetized and being ventilated on two lungs). Time 20 minutes (patient has been ventilated on one lung for 20 minutes). Time 40 minutes (following a period of 20 minutes on one intervention arm [either CPAP or HFJV]. The patient will then enter second intervention arm). Time 60 minutes ( 20 minutes after second intervention arm [either CPAP or HFJV])</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>One-Lung Ventilation</condition>
  <condition>Thoracic Surgery, Video-Assisted</condition>
  <arm_group>
    <arm_group_label>One-Lung Ventilation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>During one-lung ventilation, when the chest is open, the non-dependent lung is collapsed and manipulated by the surgeon. It is the routine procedure during video-assisted thoracic surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CPAP to non-dependent lung</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patient will be randomly assigned to the study arm &quot;Continuous Positive Airway Pressure (CPAP)&quot;. CPAP will be applied for 20 minutes to the non-dependent lung at a pressure of 2-3cmH20 using the disposable Mallinckrodt Bronchocath CPAP system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HFJV to non-dependent lung</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patient is randomly assigned to the study arm &quot;High-frequency jet ventilation (HFJV)&quot;. HFJV will be applied for 20 minutes to the non-dependent lung with a driving pressure of a 0.6 atm, respiratory rate 100 cycles per minute using the Monsoone III Jet Ventilator (Acutronic, Hirzel, Switzerland).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CPAP</intervention_name>
    <description>A recruitment maneuver will be applied to the ventilated lung. Immediately continuous positive airway pressure, at a pressure of 2-3cmH2O will applied to the non-ventilated lung for 20 minutes by the Mallinckrodt Bronchocath Disposable CPAP system (a recognised anesthetic breathing system design for CPAP).</description>
    <arm_group_label>CPAP to non-dependent lung</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>HFJV</intervention_name>
    <description>A recruitment maneuver will be applied to the ventilated lung. Immediately, high-frequency jet ventilation, with a driving pressure of 0.5 atm and a respiratory rate of 100 cycles per minute will applied to the non-ventilated lung for 20 minutes using the Monsoone III Jet Ventilator (Acutronic, Hirzel, Switzerland). Monsoone III is a recognised ventilator design for HFJV.</description>
    <arm_group_label>HFJV to non-dependent lung</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject requiring one-lung ventilation&#xD;
&#xD;
          -  Subject under video-assisted thoracic surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Emergent surgery&#xD;
&#xD;
          -  Hemodynamic instability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Galiana</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital General Universitario de Alicante</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital General Universitario de Alicante</name>
      <address>
        <city>Alicante</city>
        <zip>03010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>February 24, 2019</last_update_submitted>
  <last_update_submitted_qc>February 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital General Universitario de Alicante</investigator_affiliation>
    <investigator_full_name>María Galiana Ivars</investigator_full_name>
    <investigator_title>Head of the Section of Clinical Anesthesia and Resuscitation</investigator_title>
  </responsible_party>
  <keyword>Hypoxia</keyword>
  <keyword>High-Frequency Jet Ventilation</keyword>
  <keyword>Continuous Positive Airway Pressure</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03296449
org study id: FREQUENCY
nct id: NCT03296449
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study compares two ventilatory techniques (continuous positive airway pressure vs high
      frequency jet ventilation) during one-lung ventilation (OLV) in video-assisted thoracic
      surgery (VATS). All patients were ventilated with both ventilatory techniques and parameters
      of gas exchange were determined through arterial blood gas test.
One-lung ventilation is mandatory during most thoracic surgery procedures. During OLV,
      collapsed lung develops an intrapulmonary shunt leading to arterial hypoxemia. Since arterial
      hypoxemia is a critical intraoperative problem, many times , anesthesiologists have to use
      rescue ventilation strategies on non-dependent lung to improve arterial oxygen levels. The
      use of continuous positive airway pressure on non-dependent lung has become the most common
      technique to achieve that aim.

      High-frequency jet ventilation on non-dependent lung may be considered as an alternative way
      of ventilation of the non-dependent lung during one-lung ventilation because it provides a
      suitable gaseous exchange while facilitating minimizing surgical field motion. However, this
      ventilation maneuver is rarely use by thoracic anesthesiologists.

      Over the last years, video assisted thoracic surgery (VATS) has become widely utilized. This
      surgical technique becomes even more dependent on immobilization of the operation field than
      open-chest thoracic procedures. There is a lack of evidence in the current literature
      regarding the use of HFJV in VATS.

      The purpose of this study is to evaluate the effects of HFJV as an alternative for the
      treatment of hypoxemia in VATS.

      One-lung ventilation is mandatory during most thoracic surgery procedures. During OLV,
      collapsed lung develops an intrapulmonary shunt leading to arterial hypoxemia. Since arterial
      hypoxemia is a critical intraoperative problem, many times , anesthesiologists have to use
      rescue ventilation strategies on non-dependent lung to improve arterial oxygen levels. The
      use of continuous positive airway pressure on non-dependent lung has become the most common
      technique to achieve that aim.

      High-frequency jet ventilation on non-dependent lung may be considered as an alternative way
      of ventilation of the non-dependent lung during one-lung ventilation because provide suitable
      gaseous exchange while facilitate minimizing surgical field motion. However , this
      ventilation maneuver is rarely use by thoracic anesthesiologists.

      Over the last years, video assisted thoracic surgery (VATS) has become widely utilized. This
      surgical technique becomes even more dependent on immobilization of the operation field than
      open-chest thoracic procedures. There is a lack of evidence in the current literature about
      the use of HFJV in VATS.

      The purpose of this study is to evaluate the effects of HFJV as an alternative for the
      treatment of hypoxemia in VATS.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: PaO2/FiO2
time frame: 1 day
description: Ratio of the arterial oxygen partial pressure (PaO2) to the inspired oxygen fraction (FiO2) determination.
Time 0 (the patient is anesthetized and being ventilated on two lungs). Time 20 minutes (patient has been ventilated on one lung for 20 minutes). Time 40 minutes (following a period of 20 minutes on one intervention arm [either CPAP or HFJV]. The patient will then enter second intervention arm). Time 60 minutes ( 20 minutes after second intervention arm [either CPAP or HFJV])
measure: PaCO2
time frame: 1 day
description: Arterial carbon dioxide partial pressure determination. Time 0 (the patient is anesthetized and being ventilated on two lungs). Time 20 minutes (patient has been ventilated on one lung for 20 minutes). Time 40 minutes (following a period of 20 minutes on one intervention arm [either CPAP or HFJV]. The patient will then enter second intervention arm). Time 60 minutes ( 20 minutes after second intervention arm [either CPAP or HFJV])
measure: Operative field conditions
time frame: 1 day
description: Surgeon's subjective opinion about operating conditions during the interventions: impossible surgical access, acceptable operative filed or excellent operative field).
Time 20 minutes (patient has been ventilated on one lung for 20 minutes). Time 40 minutes (following a period of 20 minutes on one intervention arm [either CPAP or HFJV]. The patient will then enter second intervention arm). Time 60 minutes ( 20 minutes after second intervention arm [either CPAP or HFJV])
measure: Airway pressures
time frame: 1 day
description: Recording during mechanical ventilation of dependent lung airway pressures. Time 0 (the patient is anesthetized and being ventilated on two lungs). Time 20 minutes (patient has been ventilated on one lung for 20 minutes). Time 40 minutes (following a period of 20 minutes on one intervention arm [either CPAP or HFJV]. The patient will then enter second intervention arm). Time 60 minutes ( 20 minutes after second intervention arm [either CPAP or HFJV])
measure: Adverse effects and complication
time frame: 30 days
description: Any complication or adverse effect arising from ventilation techniques: need of intensive care unit admissions, re-intervention, or thoracotomy, surgical site infection, anastomosis leakage, and pneumonia.
measure: Hemodynamic parameters
time frame: 1 day
description: Heart rate and mean arterial blood pressure. Time 0 (the patient is anesthetized and being ventilated on two lungs). Time 20 minutes (patient has been ventilated on one lung for 20 minutes). Time 40 minutes (following a period of 20 minutes on one intervention arm [either CPAP or HFJV]. The patient will then enter second intervention arm). Time 60 minutes ( 20 minutes after second intervention arm [either CPAP or HFJV])
arm group label: One-Lung Ventilation
arm group type: No Intervention
description: During one-lung ventilation, when the chest is open, the non-dependent lung is collapsed and manipulated by the surgeon. It is the routine procedure during video-assisted thoracic surgery.
arm group label: CPAP to non-dependent lung
arm group type: Active Comparator
description: The patient will be randomly assigned to the study arm "Continuous Positive Airway Pressure (CPAP)". CPAP will be applied for 20 minutes to the non-dependent lung at a pressure of 2-3cmH20 using the disposable Mallinckrodt Bronchocath CPAP system.
arm group label: HFJV to non-dependent lung
arm group type: Experimental
description: The patient is randomly assigned to the study arm "High-frequency jet ventilation (HFJV)". HFJV will be applied for 20 minutes to the non-dependent lung with a driving pressure of a 0.6 atm, respiratory rate 100 cycles per minute using the Monsoone III Jet Ventilator (Acutronic, Hirzel, Switzerland).
intervention type: Procedure
intervention name: CPAP
description: A recruitment maneuver will be applied to the ventilated lung. Immediately continuous positive airway pressure, at a pressure of 2-3cmH2O will applied to the non-ventilated lung for 20 minutes by the Mallinckrodt Bronchocath Disposable CPAP system (a recognised anesthetic breathing system design for CPAP).
arm group label: CPAP to non-dependent lung
intervention type: Procedure
intervention name: HFJV
description: A recruitment maneuver will be applied to the ventilated lung. Immediately, high-frequency jet ventilation, with a driving pressure of 0.5 atm and a respiratory rate of 100 cycles per minute will applied to the non-ventilated lung for 20 minutes using the Monsoone III Jet Ventilator (Acutronic, Hirzel, Switzerland). Monsoone III is a recognised ventilator design for HFJV.
arm group label: HFJV to non-dependent lung
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maria Galiana
role: Principal Investigator
affiliation: Hospital General Universitario de Alicante
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital General Universitario de Alicante
investigator full name: María Galiana Ivars
investigator title: Head of the Section of Clinical Anesthesia and Resuscitation
sharing ipd: Undecided