<?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>IRCT2014080218649N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-04-14</date_registration>
      <primary_sponsor>Golestan University of Medical Sciences, Deputy of Research and Technology</primary_sponsor>
      <public_title>Comparison of two methods of oxygen therapy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of oxygen therapy with face mask and nasal cannula on blood oxygen saturation, nausea, vomiting and patient comfort in patients undergoing spinal anesthesia during Caesarean section at Shohada hospital in Gonbad</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16846</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The samples will be selected by through  convenience  method   and then they will be allocated in two groups using  table of random numbers.</study_design>
      <phase>4</phase>
      <hc_freetext>Condition 1: Oxygen therapy. Condition 2: Oxygen therapy. Condition 3: Oxygen therapy.</hc_freetext>
      <i_freetext>Intervention 1: Patients in this group will receive oxygen 8 liters per minute via face mask in two steps: immediately after administration of spinal anesthesia and at postoperative recovery unit. During the entire operation and up to 30 minutes after in the recovery unit oxygen  saturation  will be measured via pulse oximetry. Nausea, vomiting and patient comfort will be measured also. Intervention 2: Patients in this group will receive oxygen 4 liters per minute via nasal cannula in two steps: immediately after administration of spinal anesthesia and postoperative recovery unit. During the entire operation and up to 30 minutes after in the recovery unit oxygen saturation  will be measured via pulse oximetry. Nausea, vomiting and patient comfort will be measured also.</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>Ainaz Kor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Falsafi Educational Campus, Shastkola Road, Gorgan</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 17 3242 6900</telephone>
        <email>yazdi@goums.ac.ir,  Kor_ainaz@yahoo.com</email>
        <affiliation>Golestan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khadijeh Yazdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Falsafi Educational Campus, Shastkola Road, Gorgan</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 17 3242 6900</telephone>
        <email>yazdi@goums.ac.ir</email>
        <affiliation>Golestan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Patients undergoing spinal anesthesia for elective cesarean section, first Class of American Society of Anesthesiologists, aged from 18 to 35 years, ability to communicate verbally, body mass index in the normal range, lake of breathing problems, lack of history of gastrointestinal disease, having no risk of pregnancy, absence of any nausea and vomiting 24 hours before cesarean, not receiving preoperative intravenous narcotic, preoperative SPO2 more than 95% and Hemoglobin more than 11. &#13;
Exclusion criteria: Alteration in spinal anesthesia to general anesthesia, patient's unwillingness to continue participation in the study, need for any additional  surgery other than cesarean section for patients and prolonged  bleeding during operation.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O82</hc_code>
      <hc_code>O82.0</hc_code>
      <hc_code>O89.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Single delivery by caesarean section</hc_keyword>
      <hc_keyword>Delivery by elective caesarean section</hc_keyword>
      <hc_keyword>O89.5 Other complications of spinal and epidural anaesthesia during the puerperium</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Patients in this group will receive oxygen 8 liters per minute via face mask in two steps: immediately after administration of spinal anesthesia and at postoperative recovery unit. During the entire operation and up to 30 minutes after in the recovery unit oxygen  saturation  will be measured via pulse oximetry. Nausea, vomiting and patient comfort will be measured also.</i_keyword>
      <i_keyword>Patients in this group will receive oxygen 4 liters per minute via nasal cannula in two steps: immediately after administration of spinal anesthesia and postoperative recovery unit. During the entire operation and up to 30 minutes after in the recovery unit oxygen saturation  will be measured via pulse oximetry. Nausea, vomiting and patient comfort will be measured also.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Arterial Oxygen Saturation. Timepoint: At 5 minutes intervals during surgery and in the recovery unit. Method of measurement: Pulse oximetry for oxygen  saturation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Nausea,Vomiting and Patient Comfort. Timepoint: At 5 minutes intervals during surgery and in the recovery unit. Method of measurement: Visual scale for nausea, vomiting and  patient comfort.</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>Golestan University of Medical Sciences, Deputy of Research and Technology</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-03-02</approval_date>
        <contact_name>Ethics Committee of Golestan  University of Medical Sciences</contact_name>
        <contact_address>Falsafi Educational Campus, Shastkola Road, Gorgan Gorgan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
