<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/NCT03780218</url>
  </required_header>
  <id_info>
    <org_study_id>GO 18/1110</org_study_id>
    <nct_id>NCT03780218</nct_id>
  </id_info>
  <brief_title>Evaluation of Pulmonary Function in Burn Injury</brief_title>
  <official_title>Evaluation of Pulmonary Function and Respiratory Muscle Strength in Patients With Burn Injury.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ankara City Hospital Bilkent</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hacettepe University</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>
      This study evaluates the pulmonary function, respiratory muscle strength and peripheral&#xD;
      muscle strength in patients with burn injury on the week that they will be discharge from the&#xD;
      hospital. Healthy subjects will be evaluated for pulmonary function, respiratory muscle&#xD;
      strength and peripheral muscle strength.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Burn injures have adverse effect on the respiratory system.In addition to burn injury&#xD;
      prolonged hospitalization may increase the ratio of respiratory complications. But, there are&#xD;
      no information in the literature about pulmonary function, respiratory muscle strength and&#xD;
      peripheral muscle strength in patients with burn injury. Especially, when the patients are&#xD;
      discharged from the hospital, it is not known whether the patients are at the same level in&#xD;
      terms of pulmonary functions respiratory muscle strength and peripheral muscle strength with&#xD;
      healthy individuals. This study will assess pulmonary functions respiratory muscle strength&#xD;
      and peripheral muscle strength in patients with burn injury compared to healthy subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">October 29, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Forced Vital Capacity</measure>
    <time_frame>15 minutes</time_frame>
    <description>is the total amount of air exhaled during the test. After three trial, the best forced vital capacity value is the outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forced Expiratory Volume in 1 Second</measure>
    <time_frame>15 minutes</time_frame>
    <description>Forced Expiratory Volume in 1 Second is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. After three trial, the best FVC value is the outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forced Expiratory Volume in 1 Second / Forced Vital Capacity</measure>
    <time_frame>15 minutes</time_frame>
    <description>The ratio of Forced Expiratory Volume in 1 Second / Forced Vital Capacity. This formule is calculated by measuring device. After three trial, the best value is the outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximal Inspiratory Pressure</measure>
    <time_frame>15 minutes</time_frame>
    <description>is a measure of the strength of inspiratory muscles, primarily the diaphragm. It is obtained by having the patient inhale as strongly as possible against a mouthpiece. After three trial, the best value is the outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximal Expiratory Pressure</measure>
    <time_frame>15 minutes</time_frame>
    <description>a measure of the strength of respiratory muscles, obtained by having the patient exhale as strongly as possible against a mouthpiece. After three trial, the best value is the outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peak Expiratory Flow</measure>
    <time_frame>15 minutes</time_frame>
    <description>Peak Expiratory Flow is a person's maximum speed of expiration, as measured with a peak flow meter, a small, hand-held device used to monitor a person's ability to breathe out air. After three trial, the best value is the outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>forced expiratory flow</measure>
    <time_frame>15 minutes</time_frame>
    <description>Forced expiratory flow is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral strength</measure>
    <time_frame>15 minutes</time_frame>
    <description>Peripheral (Grip) strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain severity</measure>
    <time_frame>15 minutes</time_frame>
    <description>Pain severity was assessed by visual analogue scale. This scale score range from &quot;no pain=0 point &quot; to &quot;worst imaginable pain=10 points&quot; for intensity. Maximum point means worst pain severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Exercise Capacity</measure>
    <time_frame>10 minutes</time_frame>
    <description>It was evaluated by six minutes walk test.The 6-min walk test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The distance will be recorded. The higher distance is indicated better exercise capacity.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">94</enrollment>
  <condition>Burns</condition>
  <arm_group>
    <arm_group_label>Experimental Group:Respiratory function</arm_group_label>
    <description>Patients with burn injury will be included in this study. Their respiratory functions will be evaluated. Pulmonary function test, respiratory muscle strength and peripheral muscle strength will be assessed on the discharge week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group:Respiratory function</arm_group_label>
    <description>Healthy subjects will be included in this study.Their respiratory functions will be evaluated. Pulmonary function test, respiratory muscle strength and peripheral muscle strength will be assessed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Respiratory function</intervention_name>
    <description>Respiratory function test evaluates the participants' pulmonary function and respiratory muscle strength</description>
    <arm_group_label>Control Group:Respiratory function</arm_group_label>
    <arm_group_label>Experimental Group:Respiratory function</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Experimental group: Patients with burn injury Control Group: Healthy subjects&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having a burn injury&#xD;
&#xD;
          -  Treatment by an inpatient&#xD;
&#xD;
          -  able and willing to complete the informed consent process.&#xD;
&#xD;
          -  Control group consists of healthy adults with the similar demographic characteristics&#xD;
             as experimental group&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having a pulmonary system disease&#xD;
&#xD;
          -  having a cardiac system disease&#xD;
&#xD;
          -  to do regular sports for the last three months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ozden Ozkal</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ozden Ozkal</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>October 30, 2019</last_update_submitted>
  <last_update_submitted_qc>October 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Ozden Ozkal</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Burn Injury</keyword>
  <keyword>Pulmonary function</keyword>
  <keyword>Respiratory muscle</keyword>
  <keyword>Peripheral muscle</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burns</mesh_term>
  </condition_browse>
  <!-- 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/NCT03780218
org study id: GO 18/1110
nct id: NCT03780218
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the pulmonary function, respiratory muscle strength and peripheral
      muscle strength in patients with burn injury on the week that they will be discharge from the
      hospital. Healthy subjects will be evaluated for pulmonary function, respiratory muscle
      strength and peripheral muscle strength.
Burn injures have adverse effect on the respiratory system.In addition to burn injury
      prolonged hospitalization may increase the ratio of respiratory complications. But, there are
      no information in the literature about pulmonary function, respiratory muscle strength and
      peripheral muscle strength in patients with burn injury. Especially, when the patients are
      discharged from the hospital, it is not known whether the patients are at the same level in
      terms of pulmonary functions respiratory muscle strength and peripheral muscle strength with
      healthy individuals. This study will assess pulmonary functions respiratory muscle strength
      and peripheral muscle strength in patients with burn injury compared to healthy subjects.
observational model: Case-Control
time perspective: Prospective
measure: Forced Vital Capacity
time frame: 15 minutes
description: is the total amount of air exhaled during the test. After three trial, the best forced vital capacity value is the outcome
measure: Forced Expiratory Volume in 1 Second
time frame: 15 minutes
description: Forced Expiratory Volume in 1 Second is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. After three trial, the best FVC value is the outcome.
measure: Forced Expiratory Volume in 1 Second / Forced Vital Capacity
time frame: 15 minutes
description: The ratio of Forced Expiratory Volume in 1 Second / Forced Vital Capacity. This formule is calculated by measuring device. After three trial, the best value is the outcome.
measure: Maximal Inspiratory Pressure
time frame: 15 minutes
description: is a measure of the strength of inspiratory muscles, primarily the diaphragm. It is obtained by having the patient inhale as strongly as possible against a mouthpiece. After three trial, the best value is the outcome.
measure: Maximal Expiratory Pressure
time frame: 15 minutes
description: a measure of the strength of respiratory muscles, obtained by having the patient exhale as strongly as possible against a mouthpiece. After three trial, the best value is the outcome.
measure: Peak Expiratory Flow
time frame: 15 minutes
description: Peak Expiratory Flow is a person's maximum speed of expiration, as measured with a peak flow meter, a small, hand-held device used to monitor a person's ability to breathe out air. After three trial, the best value is the outcome.
measure: forced expiratory flow
time frame: 15 minutes
description: Forced expiratory flow is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration.
measure: Peripheral strength
time frame: 15 minutes
description: Peripheral (Grip) strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles
measure: Pain severity
time frame: 15 minutes
description: Pain severity was assessed by visual analogue scale. This scale score range from "no pain=0 point " to "worst imaginable pain=10 points" for intensity. Maximum point means worst pain severity.
measure: Functional Exercise Capacity
time frame: 10 minutes
description: It was evaluated by six minutes walk test.The 6-min walk test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The distance will be recorded. The higher distance is indicated better exercise capacity.
arm group label: Experimental Group:Respiratory function
description: Patients with burn injury will be included in this study. Their respiratory functions will be evaluated. Pulmonary function test, respiratory muscle strength and peripheral muscle strength will be assessed on the discharge week.
arm group label: Control Group:Respiratory function
description: Healthy subjects will be included in this study.Their respiratory functions will be evaluated. Pulmonary function test, respiratory muscle strength and peripheral muscle strength will be assessed.
intervention type: Other
intervention name: Respiratory function
description: Respiratory function test evaluates the participants' pulmonary function and respiratory muscle strength
arm group label: Control Group:Respiratory function
arm group label: Experimental Group:Respiratory function
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ozden Ozkal
role: Principal Investigator
affiliation: Hacettepe University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Ozden Ozkal
investigator title: Principal Investigator
mesh term: Burns