<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT2016051527908N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-01-03</date_registration>
      <primary_sponsor>Vice chancellor for research of Shahid Rajaei Cardiovascular  Medical and Research Center, Iran Univ</primary_sponsor>
      <public_title>Effect of Early mobilization  of Diaphragm Muscles strength</public_title>
      <acronym></acronym>
      <scientific_title>Effect of "early mobilization protocol" after cardiac surgery on rate diaphragmatic muscle strength</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22769</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>coronary heart disease.</hc_freetext>
      <i_freetext>Intervention 1: In intervention group: patient learns how to breathe ,then measurement of diaphragm muscle strength would be done by power breath. After surgery and emitting chip pipe patient deepens on situation ( second day after surgery) and doctor's command in first group by considering safety issues, stiller, contraindication for early mobilization by using early mobilization protocol and by physiotherapy assisting are done. At the end measuring diaphragm strength would be done before leaving ICU. Intervention 2: In control group:  patient learns how to breathe ,then measurement of diaphragm muscle strength would be done by power breath. After surgery and extubation based on doctor's command , physiotherapy would be done by physiotherapist help. At the end measuring diaphragm strength would be done before leaving ICU.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Lotfian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rajaei Cardiovascular Medical and Research Center, Vali-Asr ave., Niayesh Blvd., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2392 2489</telephone>
        <email>saralotfiyan@yahoo.com</email>
        <affiliation>Rajaei Cardiovascular Medical and Research Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara Lotfian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rajaei Cardiovascular Medical and Research Center, Vali-Asr ave., Niayesh Blvd., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2392 2489</telephone>
        <email>saralotfiyan@yahoo.com</email>
        <affiliation>Rajaei Cardiovascular Medical and Research Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Age of participants must be 20-65 years old; The surgery must be elective; The participants must not be so sleepy and agitated ( RASS between -2 and +2); The participants must not  have cardiac arrhythmia;  LVEF &gt;30%&#13;
Exclusion criteria: Having long-term mechanical ventilation (more than 48 hours); Difficulties in movement after surgery; Cardiac arrest during or after surgery; Disable to communicate because of neurological, visual or auditory disorders; If each contraindication happened in early mobilization ( FIO2 &gt;85%, PEEP&gt;15 , severe heart ischemic, uncontrolled cardiac arrhythmia, impermanent blood pressure despite receiving vasopressors, open sternum، LVEF less than 30% )&#13;
6- Known case of pulmonary disease ( diaphragm disorder, COPD, hemothorax, pleural effusion, etc);  History of thoracic surgery.; Smoking.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerotic heart disease      Coronary (artery):          atheroma         atherosclerosis         disease         sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In intervention group: patient learns how to breathe ,then measurement of diaphragm muscle strength would be done by power breath. After surgery and emitting chip pipe patient deepens on situation ( second day after surgery) and doctor's command in first group by considering safety issues, stiller, contraindication for early mobilization by using early mobilization protocol and by physiotherapy assisting are done. At the end measuring diaphragm strength would be done before leaving ICU.</i_keyword>
      <i_keyword>In control group:  patient learns how to breathe ,then measurement of diaphragm muscle strength would be done by power breath. After surgery and extubation based on doctor's command , physiotherapy would be done by physiotherapist help. At the end measuring diaphragm strength would be done before leaving ICU.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>PIMAX: maximum pressure that patient must overcome it to bring more air into lung.  SINDEX: quality criterion for measuring the breathing muscle power which is based on comparison by the amounts of same normal age, gender, height and  weight. Timepoint: patient before surgury and afther surgury and both tow group. Method of measurement: Collecting data tools for this study is power breath device which its producer is KS POWER made in England.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart rate. Timepoint: before and during admission in ICU. Method of measurement: monitoring.</sec_outcome>
      <sec_outcome>Oxygen saturation. Timepoint: before and during admission in ICU. Method of measurement: monitoring.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: before and during admission in ICU. Method of measurement: monitoring.</sec_outcome>
      <sec_outcome>Number of days admitted to ICU. Timepoint: during admission in ICU. Method of measurement: nursing report.</sec_outcome>
      <sec_outcome>Number of stages done in early mobilization protocol. Timepoint: during admission in ICU. Method of measurement: observation by researcher.</sec_outcome>
      <sec_outcome>Respiratory rate. Timepoint: before and during admission in ICU. Method of measurement: monitoring.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice chancellor for research of Shahid Rajaei Cardiovascular  Medical and Research Center, Iran Univ</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-08-06</approval_date>
        <contact_name>Tehran ,Shahid RajaeeCardiovascular Educational,Researching and clinical institute</contact_name>
        <contact_address>Rajaei Cardiovascular Medical and Research Center, Vali-Asr ave., Niayesh Blvd., Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
