<?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>IRCT2017042633657N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-06-11</date_registration>
      <primary_sponsor>Vice chancellor for research, Shahid Sadughi  University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the Effect of Endotracheal Tube Cuff Pressure on Sore Throat, Hoarseness and Cough</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the Effect of Endotracheal Tube Cuff Pressure on Sore Throat, Hoarseness and Cough in Patients with Coronary Artery Bypass Surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25905</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Angina pectoris.</hc_freetext>
      <i_freetext>Intervention 1: In the Intervention group, after intubated by an anesthesiologist (with more work experience of 5 years) (using the touch pad cuff), by trained nurses with listed for the control group (during the first 10 minutes of anesthesia) was set at a rate of 22 ± 2 cm of water (in the first endotracheal tube cuff pressure measurement, if the level it was different with the rate of 22 ± 2, first, the correction was recorded). At the time of admission to intensive care unit and in the interval of 2 hours, 4 hours and 6 hours after control and this amount has been set. Then, after removing the tube samples both within 2 hours, 6 hours, 12 and 24 hours later, by measure sore throat, cough and hoarseness, in terms of throat pain, cough and respiratory violence are investigated and recorded. Intervention 2: In order to collect data, demographic data and medical records endotracheal tube cuff pressure was used. In the Control group, patients with endotracheal tube cuff pressure by the anesthesiologist (with more work experience of 5 years) with a 10 cc syringe using the touch pad cuff; during the first 10 minutes of anesthesia, time of admission to the intensive care unit and then in a period of 2 hours, 4 hours and 6 hours later using a handheld German construction company pressure measurement range between zero and 120 cm of water, was measured and recorded. In this study, all patients participating in the study tracheal tube made of PVC with a life company (Intellectuals Health) brand was used, but lead.  So that for women size 7 - 7.5 and for men Size 8 - 8.5 Used .</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 Hassan Mondegari Bamakan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd School of Nursing and Midwifery, In Front of the Infertility Center , Bu Ali Street , Safaieh</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>mh.mandegari@ssu.ac.ir,mondegaribamakan@gmail.com</email>
        <affiliation>Yazd School of Nursing and Midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Akbar Vaezi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd School of Nursing and Midwifery, In Front of the Infertility Center , Bu Ali Street , Safaieh</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>vaeziali@ssu.ac.ir</email>
        <affiliation>Shahid Sadughi  University Of Medical Sciences - Yazd</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria were: age between 18 - 75 years ; A patient for surgery was selected for the first time ; They are between 1- 4 hours ; And the duration of Intubation during surgery less than 24 hours to prevent the impact of other detrimental factors ;  Risks of surgery at level 1 and 2 ; and the tracheal tube according to the sex of the patient ;  As well as not having a history of head and neck surgery ;  Anesthesia, medications used was similar adjustments ventilator for all patients ; And those with a history of sore throat and pharyngitis to 4 weeks prior to surgery ; And a history of respiratory problems ; Addictions, smoking and drug allergy ;  As well as patients in the study were throat pain unbearable or housing request ; Inotrope drugs or vasodilator in the intensive care unit received more than 10 microns ; Longer than 30 seconds for intubation needed ;  Or during the study needs to be repeated or replacing the pipes or more than 24 hours under ventilation were excluded from the study.</inclusion_criteria>
      <agemin>77 years</agemin>
      <agemax>20 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Angina pectoris</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the Intervention group, after intubated by an anesthesiologist (with more work experience of 5 years) (using the touch pad cuff), by trained nurses with listed for the control group (during the first 10 minutes of anesthesia) was set at a rate of 22 ± 2 cm of water (in the first endotracheal tube cuff pressure measurement, if the level it was different with the rate of 22 ± 2, first, the correction was recorded). At the time of admission to intensive care unit and in the interval of 2 hours, 4 hours and 6 hours after control and this amount has been set. Then, after removing the tube samples both within 2 hours, 6 hours, 12 and 24 hours later, by measure sore throat, cough and hoarseness, in terms of throat pain, cough and respiratory violence are investigated and recorded.</i_keyword>
      <i_keyword>In order to collect data, demographic data and medical records endotracheal tube cuff pressure was used. In the Control group, patients with endotracheal tube cuff pressure by the anesthesiologist (with more work experience of 5 years) with a 10 cc syringe using the touch pad cuff; during the first 10 minutes of anesthesia, time of admission to the intensive care unit and then in a period of 2 hours, 4 hours and 6 hours later using a handheld German construction company pressure measurement range between zero and 120 cm of water, was measured and recorded. In this study, all patients participating in the study tracheal tube made of PVC with a life company (Intellectuals Health) brand was used, but lead.  So that for women size 7 - 7.5 and for men Size 8 - 8.5 Used .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sore Throat. Timepoint: 2 hours, 6 hours, 12 and 24 hours after Extubation. Method of measurement: To search for pain from zero to 3 ; (Zero score : without sore throat ; a score of 1 : Mild sore throat (only if the person to ask) ; score 2 : moderate sore throat (pharyngitis expressed by the patient) ; grade 3 : severe sore throat (change in volume with sore throat)).</prim_outcome>
      <prim_outcome>Hoarseness. Timepoint: 2 hours , 6 hours , 12 and 24 hours after Extubation. Method of measurement: As well as a change in sound quality was defined Hoarseness and its severity was determined by 4 degrees from zero to three (zero score : without hoarseness ; 1 score : violence that only by patient reported noise during the interview ;  the score 2 : clear sound but mild violence ;  Score 3 : violence clear sound and sharp) and transfer the patient to the intensive care unit after surgery.</prim_outcome>
      <prim_outcome>Cough. Timepoint: 2 hours , 6 hours , 12 and 24 hours after Extubation. Method of measurement: To measure any cough or mild and the extreme of the scale was 0 to 4 (zero score: without coughing ;  rare 1: score ;  score 2 : casual less than an hour ;  score 3 : repeated one or more times an hour ;  the score 4 : almost unchanged).</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>Vice chancellor for research, Shahid Sadughi  University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-06-26</approval_date>
        <contact_name>Ethics Committee Of Shahid Sadughi University Of Medical  Siences</contact_name>
        <contact_address>In Front of the Infertility Center,  Bu Ali street , Safaieh Yazd  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
