<?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>IRCT2016072729100N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-10-15</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences, Vice chancellor for research</primary_sponsor>
      <public_title>The effect of a designed care plan on incidence of aspiration and ventilator associated pneumonia in intubated patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of a designed care plan on incidence of aspiration and ventilator associated pneumonia in intubated patients hospitalized in the ICU in Ali Ebne Abitaleb Hospital, Zahedan 2016</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23475</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Aspiration pneumonia.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, designed care plan to reduce the incidence of aspiration which is composed of four parts, in the intervention days (three days from the second day after intubation) will be done. The care plan has the following steps: raising the head of the bed to 30 degrees or more, the determination and management of gastric residual volume, abdominal massage, and oral care. Intervention 2: The control group receives routine care in the prevention of VAP and incidence of aspiration.</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>Parastoo Mohamadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashahir sq,</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 54 3343 0059</telephone>
        <email>mohamadi_parastoo@yahoo.com</email>
        <affiliation>Nursing and Midwifery Faculty</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Fariba Yaghoubinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashahir sq.</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 54 3343 0059</telephone>
        <email>yaghoubinia@gmail.com</email>
        <affiliation>Zahedan University of Medicine</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The inclusion criteria of the study were: being 16–65 years of age؛ the second day of intubation؛ the MCPIS score more than 5 or equal؛ the patient dosnt have pneumonia, ARDA, COPD؛ using only standard formulas for feeding؛ monitoring with mechanical ventilation for at least 96 h. &#13;
The patients with tracheostomy؛ abdominal wound؛ surgery؛ pregnancy and radiotherapy؛ ileus؛ diarrhea؛ and those using prokinetic agents؛ remove the NGT؛ changing the endothracheal tube were excluded from the study.</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>j69</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Aspiration pneumonia (due to):      NOS     food (regurgitated)     gastric secretions     milk     vomit</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, designed care plan to reduce the incidence of aspiration which is composed of four parts, in the intervention days (three days from the second day after intubation) will be done. The care plan has the following steps: raising the head of the bed to 30 degrees or more, the determination and management of gastric residual volume, abdominal massage, and oral care.</i_keyword>
      <i_keyword>The control group receives routine care in the prevention of VAP and incidence of aspiration.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ventilator associated pneumonia. Timepoint: Before intervention and at the end of intervention. Method of measurement: In this study, pneumonia means the MCPIS score more than 5. The highest  score is 10. If patients earn more than 5 point, the diagnosis of VAP is pretended.</prim_outcome>
      <prim_outcome>Aspirations. Timepoint: At the intervention days, before morning and evening massage. Method of measurement: In this study, the means of aspiration is the number of oral discharge PH that measures by test tapes. It measures each day before massage. The score less than 6 represents the aspiration.</prim_outcome>
      <prim_outcome>Gastric residual volume. Timepoint: in intervention days, at morning and evening, before gavage. Method of measurement: it means the volume of gastric content that measure by syring before each gavage.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Age. Timepoint: before intervention. Method of measurement: based on patient documented data.</sec_outcome>
      <sec_outcome>Sex. Timepoint: before intervention. Method of measurement: according to phenotype.</sec_outcome>
      <sec_outcome>History of ICU addmition. Timepoint: before intervention. Method of measurement: Patient recent hospitalization in ICU Prior to his current hospitalization.</sec_outcome>
      <sec_outcome>Underlying disease. Timepoint: before intervention. Method of measurement: medical disease such as heart, renal, neurologic, gastric, and Pulmonary ecsept for COPD, ARDS, and pneumonia.</sec_outcome>
      <sec_outcome>Volume of nutritional solution. Timepoint: before gavage within interventional days. Method of measurement: The nutritional solution volume that is prescribed by doctors.</sec_outcome>
      <sec_outcome>Times of endotracheal suctioning. Timepoint: in  each shift within interventional days. Method of measurement: The number of times that endotracheal suctioning can be performed by a nurse per shift.</sec_outcome>
      <sec_outcome>The patient's level of consciousness. Timepoint: During the intervention days, each hour. Method of measurement: GCS score of the patient in accordance with standard scale of Glasgow is controlled by a nurse every hour.</sec_outcome>
      <sec_outcome>Level of sedation. Timepoint: in  each shift within interventional days. Method of measurement: RASS is a scale score that is measured by the nurse in each shift.</sec_outcome>
      <sec_outcome>The size of the endotracheal tube. Timepoint: before intervention. Method of measurement: Internal diameter of endotracheal tube.</sec_outcome>
      <sec_outcome>Endotracheal tube cuff pressure. Timepoint: in  each shift within interventional days. Method of measurement: Endotracheal tube cuff pressure measured by the nurse on each shift by a manometer for measurement.</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>Zahedan University of Medical Sciences, Vice chancellor for research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-10</approval_date>
        <contact_name>Ethics committee of Zahedan University of Medicin</contact_name>
        <contact_address>Khalidj fars blv, Hesabi square, Zahedan Zahedan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
