xml: <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/NCT06041295</url>
    </required_header>
    <id_info>
      <org_study_id>202308062RINB</org_study_id>
      <nct_id>NCT06041295</nct_id>
    </id_info>
    <brief_title>Quality Improvement Project of Nurse Guiding Incentive Spirometry After Cardiac Surgery</brief_title>
    <official_title>Interprofessional Collaborative Practice Between Respiratory Therapists and Nurses- Quality Improvement Project of the Correct Rate of Nurse Guiding Incentive Spirometry After Cardiac Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Taiwan University Hospital</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>
        Studies have shown that patients undergoing general anesthesia surgery are prone to pulmonary&#xD;
        complications after surgery; about 30-72% of cardiac surgery patients have postoperative&#xD;
        chest X-rays that reveal lung collapse, leading to gas exchange disorders and hypoxemia.&#xD;
        Postoperative lung expansion therapy can increase ventilation-perfusion balance, increase&#xD;
        lung volume, promote respiratory mucosal sputum production and reduce postoperative pain, and&#xD;
        has been proven to improve postoperative pulmonary-related complications.&#xD;
  &#xD;
        Inducement spirometry is currently one of the mainstream methods of performing lung expansion&#xD;
        treatment. It uses visual feedback to allow the patient to perform slow, deep breathing with&#xD;
        sufficient airflow or volume to achieve the lung expansion effect; it is also used after&#xD;
        cardiac surgery in our hospital. The main way for patients to perform lung expansion therapy;&#xD;
        compared with only performing respiratory exercises after surgery, induced spirometry can&#xD;
        reduce the incidence of lung collapse and respiratory distress in postoperative patients, and&#xD;
        can also shorten the ICU stay and total hospitalization stay.&#xD;
  &#xD;
        Most cardiac surgery patients in our hospital are given health education on lung expansion&#xD;
        therapy by nursing staff before and after surgery. This unit does not have specialized&#xD;
        courses on lung expansion therapy, which may lead to differences in explanations between&#xD;
        different nursing staff; some patients' lack of knowledge and understanding of lung expansion&#xD;
        treatment resulted in the treatment effect not being as good as expected, which motivated the&#xD;
        author to formulate a project for improvement. We hope to analyze, review and improve the&#xD;
        current situation to improve the effectiveness of lung expansion treatment for patients.&#xD;
  &#xD;
        Based on the current situation analysis and relevant literature, a project to improve nursing&#xD;
        guidance for lung expansion therapy was implemented.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The following options were selected as solutions:&#xD;
  &#xD;
          1. Develop Inducement Spirometry Care Standards&#xD;
  &#xD;
          2. Organize in-service education courses on pulmonary dilatation therapy for nursing staff&#xD;
  &#xD;
          3. Make a health education leaflet on incentive spirometer and place it in the ward for&#xD;
             patients to read.&#xD;
  &#xD;
          4. Provide demonstration materials for nursing staff to experience the treatment process&#xD;
  &#xD;
        The main purposes are:&#xD;
  &#xD;
          1. Improve nursing staff's awareness of lung expansion therapy&#xD;
  &#xD;
          2. Improve the accuracy of nursing staff in performing lung expansion therapy and health&#xD;
             education&#xD;
  &#xD;
          3. Improve the accuracy of patients' lung expansion therapy&#xD;
  &#xD;
          4. Reduce the incidence of pulmonary complications in patients after cardiac surgery&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 6, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The improvement of nursing staff's awareness rate of lung expansion therapy</measure>
      <time_frame>week 2 after on-the-job training</time_frame>
      <description>The improvement before and after on-the-job training</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The improvement of nursing staff's correct rate of education of lung expansion therapy</measure>
      <time_frame>week 2 after on-the-job training</time_frame>
      <description>The improvement before and after on-the-job training</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The improvement of patients' correct rate of lung expansion therapy</measure>
      <time_frame>week 2 after nurse staff's on-the-job training</time_frame>
      <description>The improvement before and after nurse staff's on-the-job training</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The improvement of respiratory complication rate</measure>
      <time_frame>week 2 after nurse staff's on-the-job training</time_frame>
      <description>The improvement before and after nurse staff's on-the-job training</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nurses' satisfaction of the quality improvement project survey</measure>
      <time_frame>week 2 after nurse staff's on-the-job training</time_frame>
      <description>Nurses' satisfaction of the quality improvement project</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Lung Expansion Therapy</condition>
    <condition>Post-cardiac Surgery</condition>
    <arm_group>
      <arm_group_label>the cardiovascular surgery ICU nurse staff</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>on-the-job training of lung expansion therapy</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>on-the-job training of lung expansion therapy</intervention_name>
      <description>on-the-job training of lung expansion therapy</description>
      <arm_group_label>the cardiovascular surgery ICU nurse staff</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Nurses:&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Nurse staff in cardiovascular surgery ICU of National Taiwan University Hospital&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  None&#xD;
  &#xD;
          Patients:&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years of age and above&#xD;
  &#xD;
            -  Perform cardiovascular surgeries at National Taiwan University Hospital&#xD;
  &#xD;
            -  After surgery, the endotracheal tube is inserted and admitted to the cardiovascular&#xD;
               surgery intensive care unit, and the endotracheal tube is removed in the intensive&#xD;
               care unit.&#xD;
  &#xD;
            -  There is a clinical indication to perform lung expansion therapy&#xD;
  &#xD;
            -  Clear consciousness and able to cooperate with instructions&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Hemodynamic instability (mean arterial pressure remains below 60 mmHg after infusion&#xD;
               or vasopressor administration)&#xD;
  &#xD;
            -  Severe lung diseases (such as uncontrollable asthma, severe pulmonary obstruction,&#xD;
               untreated pneumothorax, etc.)&#xD;
  &#xD;
            -  Unable to perform effective deep breathing (for example: vital capacity is less than&#xD;
               10 ml/kg or inspiratory capacity is less than 1/3 of the predicted value)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yi-Ting Hung, Bachelor</last_name>
      <phone>+886-910720142</phone>
      <email>birdymkii@gmail.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06041295
  org study id: 202308062RINB
  nct id: NCT06041295
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Studies have shown that patients undergoing general anesthesia surgery are prone to pulmonary
        complications after surgery; about 30-72% of cardiac surgery patients have postoperative
        chest X-rays that reveal lung collapse, leading to gas exchange disorders and hypoxemia.
        Postoperative lung expansion therapy can increase ventilation-perfusion balance, increase
        lung volume, promote respiratory mucosal sputum production and reduce postoperative pain, and
        has been proven to improve postoperative pulmonary-related complications.
  
        Inducement spirometry is currently one of the mainstream methods of performing lung expansion
        treatment. It uses visual feedback to allow the patient to perform slow, deep breathing with
        sufficient airflow or volume to achieve the lung expansion effect; it is also used after
        cardiac surgery in our hospital. The main way for patients to perform lung expansion therapy;
        compared with only performing respiratory exercises after surgery, induced spirometry can
        reduce the incidence of lung collapse and respiratory distress in postoperative patients, and
        can also shorten the ICU stay and total hospitalization stay.
  
        Most cardiac surgery patients in our hospital are given health education on lung expansion
        therapy by nursing staff before and after surgery. This unit does not have specialized
        courses on lung expansion therapy, which may lead to differences in explanations between
        different nursing staff; some patients' lack of knowledge and understanding of lung expansion
        treatment resulted in the treatment effect not being as good as expected, which motivated the
        author to formulate a project for improvement. We hope to analyze, review and improve the
        current situation to improve the effectiveness of lung expansion treatment for patients.
  
        Based on the current situation analysis and relevant literature, a project to improve nursing
        guidance for lung expansion therapy was implemented.
  The following options were selected as solutions:
  
          1. Develop Inducement Spirometry Care Standards
  
          2. Organize in-service education courses on pulmonary dilatation therapy for nursing staff
  
          3. Make a health education leaflet on incentive spirometer and place it in the ward for
             patients to read.
  
          4. Provide demonstration materials for nursing staff to experience the treatment process
  
        The main purposes are:
  
          1. Improve nursing staff's awareness of lung expansion therapy
  
          2. Improve the accuracy of nursing staff in performing lung expansion therapy and health
             education
  
          3. Improve the accuracy of patients' lung expansion therapy
  
          4. Reduce the incidence of pulmonary complications in patients after cardiac surgery
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: The improvement of nursing staff's awareness rate of lung expansion therapy
  time frame: week 2 after on-the-job training
  description: The improvement before and after on-the-job training
  measure: The improvement of nursing staff's correct rate of education of lung expansion therapy
  time frame: week 2 after on-the-job training
  description: The improvement before and after on-the-job training
  measure: The improvement of patients' correct rate of lung expansion therapy
  time frame: week 2 after nurse staff's on-the-job training
  description: The improvement before and after nurse staff's on-the-job training
  measure: The improvement of respiratory complication rate
  time frame: week 2 after nurse staff's on-the-job training
  description: The improvement before and after nurse staff's on-the-job training
  measure: Nurses' satisfaction of the quality improvement project survey
  time frame: week 2 after nurse staff's on-the-job training
  description: Nurses' satisfaction of the quality improvement project
  arm group label: the cardiovascular surgery ICU nurse staff
  arm group type: Experimental
  description: on-the-job training of lung expansion therapy
  intervention type: Behavioral
  intervention name: on-the-job training of lung expansion therapy
  description: on-the-job training of lung expansion therapy
  arm group label: the cardiovascular surgery ICU nurse staff
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yi-Ting Hung, Bachelor
  phone: +886-910720142
  email: birdymkii@gmail.com
  responsible party type: Sponsor
  sharing ipd: No