<?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>IRCT201011012560N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2010-12-02</date_registration>
      <primary_sponsor>Qom University of Medical Sciences and Health Services</primary_sponsor>
      <public_title>Effect of deep breathing exercises on oxygenation of patients undergoing major abdominal surgery</public_title>
      <acronym></acronym>
      <scientific_title>Effect of deep breathing exercises on oxygenation of patients undergoing major abdominal surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2309</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Acute pulmonary insufficiency following obdoman surgery.</hc_freetext>
      <i_freetext>Intervention 1: Experimental group: The patients in the experimental group will be informed and practiced the breathing technique preoperatively. Deep breathing exercise (DBE) will be initiated approximately 2 hours after surgery when patients awake (in daytime). While resting in a semi-recumbent position, the patients will be instructed to inhale as slowly and deeply as possible, hold their breath for 3 seconds, and then exhale in a relaxed manner while coughing during it. With the help of a researcher nurse using proprioceptive input, the patients will be encouraged to make each subsequent breath deeper than the previous breath for 10 breaths. After 10 breaths, the patients will perform incentive spirometry by latex glove for 2 minute. These periods will be followed by a rest period (ie, normal breathing), and the cycle will be repeated four times per hour for 2 consecutive hours. Intervention 2: Control group: Patients in the control group receive routine care by the nurses. They don't receive any deep breathing exercise (DBE).</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>Mohammad Reza Yeganeh khah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 12, 2 Senobar lane., Sepideh Ave., Bahrami st., Saeedi highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6630 4368</telephone>
        <email>yeganeh3603@yahoo.com</email>
        <affiliation>Qom University of Medical Sciences and Health Services</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Reza Yeganeh khah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 12, 2 Senobar lane., Sepideh Ave., Bahrami st., Saeedi highway</address>
        <city>Tehrah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6630 4368</telephone>
        <email>yeganeh3603@yahoo.com</email>
        <affiliation>Qom University of Medical Sciences and Health Services</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1) Patients who undergoing elective major abdominal surgery. 2) Having complete alert and ability of patient to performing deep-breathing exercises. 3) Having no history of surgery. 4) Patients undergoing general anesthesia. 5) Not to use pulmonary drugs.   Exclusive criteria: 1) Patients with active pulmonary pathology (COPD and Asthma), CHF, CRF and unstable cardiovascular condition. 2) active pulmonary and cardiac pathology (eg, ARDS and unstable angina). 3) Patients with an indication for liver transplantation, or who presented aneurysm of any arterial segment. 4) Patients with active bleeding after surgery and who needed to operating room or who transferred to intensive care unit. 5) Patients with pulmonary aspiration and temperature over 38° c.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J95.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute pulmonary insufficiency following nonthoracic surgery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Experimental group: The patients in the experimental group will be informed and practiced the breathing technique preoperatively. Deep breathing exercise (DBE) will be initiated approximately 2 hours after surgery when patients awake (in daytime). While resting in a semi-recumbent position, the patients will be instructed to inhale as slowly and deeply as possible, hold their breath for 3 seconds, and then exhale in a relaxed manner while coughing during it. With the help of a researcher nurse using proprioceptive input, the patients will be encouraged to make each subsequent breath deeper than the previous breath for 10 breaths. After 10 breaths, the patients will perform incentive spirometry by latex glove for 2 minute. These periods will be followed by a rest period (ie, normal breathing), and the cycle will be repeated four times per hour for 2 consecutive hours.</i_keyword>
      <i_keyword>Control group: Patients in the control group receive routine care by the nurses. They don't receive any deep breathing exercise (DBE).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>SpO2. Timepoint: before surgery and before and immediately after deep breathing exercise. Method of measurement: Pulse oximetry.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: Before surgery and before and immediately after deep breathing exercise. Method of measurement: monitoring equipment.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: Before surgery and before and immediately after deep breathing exercise. Method of measurement: monitoring equipment.</prim_outcome>
      <prim_outcome>Mean arterial pressure. Timepoint: Before surgery and before and immediately after deep breathing exercise. Method of measurement: monitoring equipment.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Before deep breathing exercise. Method of measurement: visual pain scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Qom University of Medical Sciences and Health Services</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-10-21</approval_date>
        <contact_name>Qom University of Medical Sciences and Health Services</contact_name>
        <contact_address>Saheli st. Qom  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
