<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/NCT03754985</url>
  </required_header>
  <id_info>
    <org_study_id>0024-16-ASF</org_study_id>
    <nct_id>NCT03754985</nct_id>
  </id_info>
  <brief_title>Hyperbaric Oxygen Therapy Effects on Pulmonary Functions</brief_title>
  <acronym>PulmHBOT</acronym>
  <official_title>Hyperbaric Oxygen Therapy Effects on Pulmonary Functions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assaf-Harofeh Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assaf-Harofeh Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective analysis included patients, 18 years or older, scheduled for 60 daily HBOT&#xD;
      sessions between 2016-2018. Each session was 90 min of 100% oxygen at 2 ATA with 5 minutes&#xD;
      air breaks every 20 min, five days per week. Pulmonary functions,measured at baseline and&#xD;
      after HBOT,included forced vital capacity (FVC), forced expiratory volume in one second&#xD;
      (FEV1), peak expiratory flow rate (PEF).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After signing an informed consent form, the participants underwent a pulmonary function&#xD;
      baseline evaluation. Participants were treated in a multiplace chamber (HAUX-Life-Support&#xD;
      GmbH) for 60 daily sessions, 5 days a week. Each session consisted of 90 minutes of exposure&#xD;
      to 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes. Participants repeated&#xD;
      their pulmonary function evaluation after the last HBOT session.&#xD;
&#xD;
      Pulmonary function Measurements of pulmonary functions were performed using the MiniSpir&#xD;
      testing apparatus (MIR- Medical International Research, USA). The equipment was calibrated&#xD;
      using a 3-liter syringe before performing measurements according to the manufacturer's&#xD;
      instructions. Measurements were performed by a trained technician. The forced expiratory&#xD;
      maneuvers were performed as recommended by the guidelines[13].&#xD;
&#xD;
      The forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and peak&#xD;
      expiratory flow rate (PEF) were taken as the highest readings obtained from at least three&#xD;
      satisfactory forced expiratory maneuvers. Mean forced mid-expiratory flow rate (FEF25-75%)&#xD;
      and forced expiratory flow rates at 25, 50 and 75% of FVC expired (FEF25%, FEF50% and FEF75%)&#xD;
      were taken as the best values from flow-volume loops not differing by &gt;5% from the highest&#xD;
      FVC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Actual">October 2018</completion_date>
  <primary_completion_date type="Actual">September 2018</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>forced vital capacity (FVC)</measure>
    <time_frame>change within 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>forced expiratory volume in one second (FEV1)</measure>
    <time_frame>change within 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>peak expiratory flow rate (PEF)</measure>
    <time_frame>change within 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>forced mid-expiratory flow rate (FEF25-75%)</measure>
    <time_frame>change within 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>FEV1/FVC ratio</measure>
    <time_frame>change within 3 months</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">105</enrollment>
  <condition>Oxygen Toxicity</condition>
  <condition>Hyperoxia</condition>
  <arm_group>
    <arm_group_label>Hyperbaric Oxygen Therapy</arm_group_label>
    <description>The study included participants 18 years or older, scheduled for 60 HBOT sessions for any indication.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hyperbaric oxygen therapy</intervention_name>
    <description>The study included participants 18 years or older, scheduled for 60 HBOT sessions for any indication.&#xD;
After signing an informed consent form, the participants underwent a pulmonary function baseline evaluation. Participants were treated in a multiplace chamber (HAUX-Life-Support GmbH) for 60 daily sessions, 5 days a week. Each session consisted of 90 minutes of exposure to 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes. Participants repeated their pulmonary function evaluation after the last HBOT session.&#xD;
After signing an informed consent form, the participants underwent a pulmonary function baseline evaluation. Participants were treated in a multiplace chamber (HAUX-Life-Support GmbH) for 60 daily sessions, 5 days a week. Each session consisted of 90 minutes of exposure to 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes. Participants repeated their pulmonary function evaluation after the last HBOT session.</description>
    <arm_group_label>Hyperbaric Oxygen Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study included participants 18 years or older, scheduled for 60 HBOT sessions for any&#xD;
        indication&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 and older patients&#xD;
&#xD;
          -  scheduled for 60 HBOT sessions for any indication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active smokers were excluded but patients who quit smoking more than six months prior&#xD;
             to inclusion were allowed in the study.&#xD;
&#xD;
          -  active smoking&#xD;
&#xD;
          -  severe known pulmonary disease&#xD;
&#xD;
          -  chest pathology incompatible with HBOT&#xD;
&#xD;
          -  inner ear disease&#xD;
&#xD;
          -  claustrophobia&#xD;
&#xD;
          -  other neurological conditions&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  previous HBOT within six months prior to inclusion&#xD;
&#xD;
          -  the inability to sign informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Amir Hadanny, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assaf-Harofeh Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Amir Hadanny</name>
      <address>
        <city>Zerifin</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 25, 2018</last_update_submitted>
  <last_update_submitted_qc>November 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperoxia</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/NCT03754985
org study id: 0024-16-ASF
nct id: NCT03754985
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Prospective analysis included patients, 18 years or older, scheduled for 60 daily HBOT
      sessions between 2016-2018. Each session was 90 min of 100% oxygen at 2 ATA with 5 minutes
      air breaks every 20 min, five days per week. Pulmonary functions,measured at baseline and
      after HBOT,included forced vital capacity (FVC), forced expiratory volume in one second
      (FEV1), peak expiratory flow rate (PEF).
After signing an informed consent form, the participants underwent a pulmonary function
      baseline evaluation. Participants were treated in a multiplace chamber (HAUX-Life-Support
      GmbH) for 60 daily sessions, 5 days a week. Each session consisted of 90 minutes of exposure
      to 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes. Participants repeated
      their pulmonary function evaluation after the last HBOT session.

      Pulmonary function Measurements of pulmonary functions were performed using the MiniSpir
      testing apparatus (MIR- Medical International Research, USA). The equipment was calibrated
      using a 3-liter syringe before performing measurements according to the manufacturer's
      instructions. Measurements were performed by a trained technician. The forced expiratory
      maneuvers were performed as recommended by the guidelines[13].

      The forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and peak
      expiratory flow rate (PEF) were taken as the highest readings obtained from at least three
      satisfactory forced expiratory maneuvers. Mean forced mid-expiratory flow rate (FEF25-75%)
      and forced expiratory flow rates at 25, 50 and 75% of FVC expired (FEF25%, FEF50% and FEF75%)
      were taken as the best values from flow-volume loops not differing by >5% from the highest
      FVC.
observational model: Cohort
time perspective: Prospective
measure: forced vital capacity (FVC)
time frame: change within 3 months
measure: forced expiratory volume in one second (FEV1)
time frame: change within 3 months
measure: peak expiratory flow rate (PEF)
time frame: change within 3 months
measure: forced mid-expiratory flow rate (FEF25-75%)
time frame: change within 3 months
measure: FEV1/FVC ratio
time frame: change within 3 months
arm group label: Hyperbaric Oxygen Therapy
description: The study included participants 18 years or older, scheduled for 60 HBOT sessions for any indication.
intervention type: Device
intervention name: Hyperbaric oxygen therapy
description: The study included participants 18 years or older, scheduled for 60 HBOT sessions for any indication.
After signing an informed consent form, the participants underwent a pulmonary function baseline evaluation. Participants were treated in a multiplace chamber (HAUX-Life-Support GmbH) for 60 daily sessions, 5 days a week. Each session consisted of 90 minutes of exposure to 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes. Participants repeated their pulmonary function evaluation after the last HBOT session.
After signing an informed consent form, the participants underwent a pulmonary function baseline evaluation. Participants were treated in a multiplace chamber (HAUX-Life-Support GmbH) for 60 daily sessions, 5 days a week. Each session consisted of 90 minutes of exposure to 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes. Participants repeated their pulmonary function evaluation after the last HBOT session.
arm group label: Hyperbaric Oxygen Therapy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Amir Hadanny, MD
role: Principal Investigator
affiliation: Assaf-Harofeh Medical Center
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Hyperoxia
sharing ipd: No