<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03816371</url>
  </required_header>
  <id_info>
    <org_study_id>3029</org_study_id>
    <nct_id>NCT03816371</nct_id>
  </id_info>
  <brief_title>The Effects of Different Degrees of Head-of-bed Elevation</brief_title>
  <official_title>The Effects of Different Degrees of Head-of-bed Elevation on the Respiratory Pattern and Drainage Following Thyroidectomy: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Necmettin Erbakan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Necmettin Erbakan University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The patient's position is important for ensuring patient comfort and preventing complications&#xD;
      after thyroidectomy. This study was carried out to determine the effects of different degrees&#xD;
      of head-of-bed elevation on the respiratory pattern and drainage following thyroidectomy and&#xD;
      to provide suggestions for evidence-based clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thyroidectomy is a safe surgical procedure commonly used for the treatment of benign or&#xD;
      malignant tumors, multinodular goiter and Graves disease. However, because of the rich&#xD;
      vascular structure of the thyroid gland, serious complications including hemorrhage, hematoma&#xD;
      and hematoma-related dyspnea can develop after thyroidectomy. The American Thyroid&#xD;
      Association also suggested to keep the patient in a head-up at 45°-Fowler's position in the&#xD;
      post anesthesia care unit following thyroidectomy to prevent hematoma formation on the&#xD;
      incision site by facilitating venous return from the head and neck. The mentioned guideline&#xD;
      does not offer any recommendations regarding the position that should be given to the&#xD;
      patients at surgical clinic after thyroidectomy. Therefore, this study aimed to identify the&#xD;
      effects of different degrees of head-of-bed elevation on respiratory pattern including&#xD;
      respiratory rate, peripheral oxygen saturation and dyspnea, and drainage including amount of&#xD;
      drainage and hematoma formation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2013</start_date>
  <completion_date type="Actual">September 30, 2013</completion_date>
  <primary_completion_date type="Actual">September 30, 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This study was conducted as a prospective, single-center, parallel, three arm (1:1:1), randomized controlled trial at the Endocrine Surgery Clinic of a university hospital in Turkey.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Group allocation was concealed using individual sealed opaque envelopes that were numbered in sequential order. As individuals were enrolled in the study, the next envelope in the sequence was extracted and the participant was assigned to the groups accordingly. All the researchers except for the clinical nurse who positioned the patients according to randomization list and patients were blinded from group assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Respiration rate</measure>
    <time_frame>Every hour during four hours</time_frame>
    <description>Number of breaths per minute. It is counted for one minute.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peripheral oxygen saturation</measure>
    <time_frame>Every hour during four hours</time_frame>
    <description>This oxygen saturation level is used to estimate arterial blood saturation and refers to the amount of oxygenated haemoglobin in the blood. It is measured by an indirect device using non-invasive method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of drainage</measure>
    <time_frame>Every hour during four hours</time_frame>
    <description>Drainage is the accumulation of blood in the drain suction bottle. The symptoms including red drainage and drainage more than 150 ml per hour in the suction bottle are defined as bleeding.The drain in the suction bottle is recorded hourly.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dyspnea</measure>
    <time_frame>Every hour during four hours</time_frame>
    <description>Shortness of breath (dyspnea) is defined a subjective experience by individuals who complain of unpleasant or uncomfortable respiratory sensations. It is evaluated by patient expression and various instruments.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematoma formation</measure>
    <time_frame>Every hour during four hours</time_frame>
    <description>Hematoma is localized swelling that is filled with blood caused by a break in the wall of a blood vessel. It is evaluated by monitoring warning signs such as progressive neck swelling, hypoxia, tachycardia, dyspnea and stridor.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Surgery</condition>
  <condition>Thyroid</condition>
  <condition>Nursing Caries</condition>
  <arm_group>
    <arm_group_label>supine 0 degree head-of-bed elevation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>0 degree head-of-bed elevation was arranged as soon as the patient was admitted to the bed following thyroidectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>30 degree head-of-bed elevation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 degree head-of-bed elevation was arranged as soon as the patient was admitted to the bed following thyroidectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>45 degree head-of-bed elevation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>45 degree head-of-bed elevation was arranged as soon as the patient was admitted to the bed following thyroidectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Head-of-bed elevation</intervention_name>
    <description>Respiratory pattern including respiratory rate, peripheral oxygen saturation and dyspnea, and drainage including amount of drainage and hematoma formation of all patients were evaluated at 1st, 2nd, 3rd, and 4th hours after positions.</description>
    <arm_group_label>30 degree head-of-bed elevation</arm_group_label>
    <arm_group_label>45 degree head-of-bed elevation</arm_group_label>
    <arm_group_label>supine 0 degree head-of-bed elevation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: The eligible participants were those&#xD;
&#xD;
          -  who were not using anticoagulants,&#xD;
&#xD;
          -  whose coagulation tests were normal,&#xD;
&#xD;
          -  who had hemovac drains inserted during thyroidectomy,&#xD;
&#xD;
          -  who had no contraindication to positioning (e.g., heart failure, chronic obstructive&#xD;
             pulmonary disease, dyspnea before surgery and respiratory complications in the&#xD;
             post-anesthesia care unit),&#xD;
&#xD;
          -  who could tolerate positioning, and who volunteered to participate and signed the&#xD;
             informed consent form&#xD;
&#xD;
        Exclusion Criteria:The participants excluded from the study;&#xD;
&#xD;
          -  who were using anticoagulants,&#xD;
&#xD;
          -  whose coagulation tests were abnormal,&#xD;
&#xD;
          -  who had hemovac drains inserted during thyroidectomy,&#xD;
&#xD;
          -  hemovac drains removed in the post-anesthesia care unit following thyroidectomy,&#xD;
&#xD;
          -  who did not tolerate positioning and who refused to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Serpil Yüksel, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Necmettin Erbakan University</affiliation>
  </overall_official>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 24, 2019</last_update_submitted>
  <last_update_submitted_qc>January 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Necmettin Erbakan University</investigator_affiliation>
    <investigator_full_name>Serpil Yüksel</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>thyroidectomy</keyword>
  <keyword>head-of-bed elevation</keyword>
  <keyword>supine position</keyword>
  <keyword>respiratory pattern</keyword>
  <keyword>amount of drainage</keyword>
  <keyword>peripheral oxygen saturation</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03816371
org study id: 3029
nct id: NCT03816371
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The patient's position is important for ensuring patient comfort and preventing complications
      after thyroidectomy. This study was carried out to determine the effects of different degrees
      of head-of-bed elevation on the respiratory pattern and drainage following thyroidectomy and
      to provide suggestions for evidence-based clinical practice.
Thyroidectomy is a safe surgical procedure commonly used for the treatment of benign or
      malignant tumors, multinodular goiter and Graves disease. However, because of the rich
      vascular structure of the thyroid gland, serious complications including hemorrhage, hematoma
      and hematoma-related dyspnea can develop after thyroidectomy. The American Thyroid
      Association also suggested to keep the patient in a head-up at 45°-Fowler's position in the
      post anesthesia care unit following thyroidectomy to prevent hematoma formation on the
      incision site by facilitating venous return from the head and neck. The mentioned guideline
      does not offer any recommendations regarding the position that should be given to the
      patients at surgical clinic after thyroidectomy. Therefore, this study aimed to identify the
      effects of different degrees of head-of-bed elevation on respiratory pattern including
      respiratory rate, peripheral oxygen saturation and dyspnea, and drainage including amount of
      drainage and hematoma formation.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study was conducted as a prospective, single-center, parallel, three arm (1:1:1), randomized controlled trial at the Endocrine Surgery Clinic of a university hospital in Turkey.
primary purpose: Other
masking: Single (Participant)
masking description: Group allocation was concealed using individual sealed opaque envelopes that were numbered in sequential order. As individuals were enrolled in the study, the next envelope in the sequence was extracted and the participant was assigned to the groups accordingly. All the researchers except for the clinical nurse who positioned the patients according to randomization list and patients were blinded from group assignment.
measure: Respiration rate
time frame: Every hour during four hours
description: Number of breaths per minute. It is counted for one minute.
measure: Peripheral oxygen saturation
time frame: Every hour during four hours
description: This oxygen saturation level is used to estimate arterial blood saturation and refers to the amount of oxygenated haemoglobin in the blood. It is measured by an indirect device using non-invasive method.
measure: Amount of drainage
time frame: Every hour during four hours
description: Drainage is the accumulation of blood in the drain suction bottle. The symptoms including red drainage and drainage more than 150 ml per hour in the suction bottle are defined as bleeding.The drain in the suction bottle is recorded hourly.
measure: Dyspnea
time frame: Every hour during four hours
description: Shortness of breath (dyspnea) is defined a subjective experience by individuals who complain of unpleasant or uncomfortable respiratory sensations. It is evaluated by patient expression and various instruments.
measure: Hematoma formation
time frame: Every hour during four hours
description: Hematoma is localized swelling that is filled with blood caused by a break in the wall of a blood vessel. It is evaluated by monitoring warning signs such as progressive neck swelling, hypoxia, tachycardia, dyspnea and stridor.
arm group label: supine 0 degree head-of-bed elevation
arm group type: Active Comparator
description: 0 degree head-of-bed elevation was arranged as soon as the patient was admitted to the bed following thyroidectomy.
arm group label: 30 degree head-of-bed elevation
arm group type: Experimental
description: 30 degree head-of-bed elevation was arranged as soon as the patient was admitted to the bed following thyroidectomy.
arm group label: 45 degree head-of-bed elevation
arm group type: Experimental
description: 45 degree head-of-bed elevation was arranged as soon as the patient was admitted to the bed following thyroidectomy.
intervention type: Other
intervention name: Head-of-bed elevation
description: Respiratory pattern including respiratory rate, peripheral oxygen saturation and dyspnea, and drainage including amount of drainage and hematoma formation of all patients were evaluated at 1st, 2nd, 3rd, and 4th hours after positions.
arm group label: 30 degree head-of-bed elevation
arm group label: 45 degree head-of-bed elevation
arm group label: supine 0 degree head-of-bed elevation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Serpil Yüksel, PhD
role: Principal Investigator
affiliation: Necmettin Erbakan University
responsible party type: Principal Investigator
investigator affiliation: Necmettin Erbakan University
investigator full name: Serpil Yüksel
investigator title: Assistant Professor
sharing ipd: No