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/NCT06013891</url>
    </required_header>
    <id_info>
      <org_study_id>F-22045028</org_study_id>
      <nct_id>NCT06013891</nct_id>
    </id_info>
    <brief_title>Observational Study of Early Postoperative Deterioration and Complications</brief_title>
    <official_title>The Incidence and Association of PACU Course and Early Postoperative Complications and Deterioration</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Copenhagen University Hospital, Hvidovre</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Copenhagen University Hospital, Hvidovre</source>
    <oversight_info>
      <has_dmc>Yes</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>
        This prospective observational research project aims to investigate how vital sign&#xD;
        deterioration and complications within the (PACU) relate to early deterioration and&#xD;
        complications in the surgical wards 72 hours post-PACU discharge.&#xD;
  &#xD;
        The participants studied will be high-risk surgical patients who will follow a normal&#xD;
        postoperative course from the PACU to the surgical ward. The investigators seek to evaluate&#xD;
        the association between deterioration and complications within the PACU with vital signs&#xD;
        deterioration and complications in the surgical wards. Second, the investigators will explore&#xD;
        how deterioration and complications affect PACU length of stay, morbidity, mortality, rapid&#xD;
        response Teams call-outs (RRT) (Early warning score &gt;7), extra medical patient supervision,&#xD;
        and unplanned intensive care unit (ICU) admissions. The investigators will also examine the&#xD;
        nurses' assessment of the patient's risk of deterioration and complications upon discharge&#xD;
        from the PACU and admission to the surgical department.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Postoperative complications are increasing and are an under-recognized cause of morbidity and&#xD;
        mortality. While there has been significant attention to preoperative risk assessments for&#xD;
        late postoperative complications and 30-day mortality, little attention has been paid to the&#xD;
        PACU as a point of in-patient triage for early postoperative deterioration and complications.&#xD;
        PACU to surgical ward discharge readiness is often based on a quantitative discharge score&#xD;
        that does not account for the patient's physiological responses or distinguish between&#xD;
        surgery type, age, and co-morbidities.&#xD;
  &#xD;
        The discharge score is a clinical decision-making tool that sets the frame for the patient's&#xD;
        readiness for discharge and functions as a &quot;one six fits all&quot; system. However, this &quot;one size&#xD;
        fits all&quot; approach may not be adequate as a discharge tool when discharging high-risk,&#xD;
        fragile patients from the PACU. The current evidence on using criterion-based discharge&#xD;
        scores and the connection with early postoperative deterioration and complications are absent&#xD;
        and need further investigation.&#xD;
  &#xD;
        It is unclear whether early postoperative deterioration and complications can be predicted&#xD;
        and assessed during PACU stay. Thus leaving a big potential for improvement in patient&#xD;
        assessment and detection of early deterioration and complications, improving safe PACU&#xD;
        discharge for high-risk fragile patients. Providing new knowledge on early postoperative&#xD;
        deterioration and complications within high-risk, fragile patient groups could improve&#xD;
        postoperative courses and patient safety.&#xD;
  &#xD;
        Statistical analysis plan Data is expected to be divided into two (or 3) consecutive studies.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 4, 2023</start_date>
    <completion_date type="Anticipated">February 27, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 27, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The incidence of deterioration and complications during PACU stay</measure>
      <time_frame>Up to four our days</time_frame>
      <description>In accordance with ICH-GCP: any untoward medical occurrence that(...)&#xD;
  Results in death&#xD;
  Is life-threatening&#xD;
  Requires inpatient hospitalization or causes prolongation of existing hospitalization&#xD;
  Results in persistent or significant disability/incapacity&#xD;
  Requires intervention to prevent permanent impairment or damage And/or severe deviating vital signs defined as outside normal thresholds.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The incidence of deterioration and complications during the first 72 hours post-PACU discharge and its association with deterioration and complication rates in the PACU</measure>
      <time_frame>Up to three days</time_frame>
      <description>In accordance with ICH-GCP: any untoward medical occurrence that(...)&#xD;
  Results in death&#xD;
  Is life-threatening&#xD;
  Requires inpatient hospitalization or causes prolongation of existing hospitalization&#xD;
  Results in persistent or significant disability/incapacity&#xD;
  Requires intervention to prevent permanent impairment or damage And/or severe deviating vital signs defined as outside normal thresholds.</description>
    </primary_outcome>
    <other_outcome>
      <measure>The association between deterioration, complications, and PACU length of stay</measure>
      <time_frame>Up to 24 hours</time_frame>
      <description>How are deterioration and/or complications associated with prolonged PACU stay PACU length of stay? (&gt; 2 hours)</description>
    </other_outcome>
    <other_outcome>
      <measure>The association between individual PACU discharge score and early risk of deterioration and complications within 72 hours post-PACU discharge</measure>
      <time_frame>Up tp 72 hours</time_frame>
      <description>Can the discharge score (modified Aldrete score/aggregated score of vital signs) be a predictive value (of high individual or high total score) for early risk of deterioration and complications</description>
    </other_outcome>
    <other_outcome>
      <measure>The percentages of RRT call-outs (Early warning score &gt;7) within 72 hours post-PACU discharge</measure>
      <time_frame>Up to 72 hours post PACU discharge</time_frame>
      <description>How many patients will experience an Early Warning Score &gt;7 (Early warning score is an aggregated score of physiological parameter). At a high score of equal to or above 7, the RRT should be contacted)</description>
    </other_outcome>
    <other_outcome>
      <measure>The percentages of extra medical, surgical, or ICU supervision within 72 hours post-PACU discharge</measure>
      <time_frame>Up to 72 hours post PACU discharge</time_frame>
      <description>How many patients will experience extra medical, surgical, or ICU supervision within 72 hours</description>
    </other_outcome>
    <other_outcome>
      <measure>The percentages of unexpected patient transfer to cardiology, the pulmonary department, or the ICU</measure>
      <time_frame>Up to four days from PACU admittance</time_frame>
      <description>How many patients will experience unexpected transfer to cardiology, the pulmonary department, or the ICU</description>
    </other_outcome>
    <other_outcome>
      <measure>PACU nurse prediction (triage categories) of the patient course within 72 hours post-PACU discharge</measure>
      <time_frame>At PACU discharge to surgical ward (up to 24 hours from PACU admittance)</time_frame>
      <description>The triage categories are; green) stable and uncomplicated postoperative course. Yellow) Potentially unstable with a risk of minor risk of a complicated postoperative course. Orange) Unstable, at high risk of a complicated postoperative course. Red) in a critical condition with the risk off life-threatening complications</description>
    </other_outcome>
    <other_outcome>
      <measure>Surgical ward nurse prediction (triage categories) of the patient course within 72 hours post-PACU discharge</measure>
      <time_frame>When the ward nurse receive the patient from the PACU (up to 24 hours of PACU admittance)</time_frame>
      <description>What are the receiving ward nurse's clinical predictions of the patient course within 72 hours post-PACU discharge. The triage categories are; green) stable and uncomplicated postoperative course. Yellow) Potentially unstable with a risk of minor risk of a complicated postoperative course. Orange) Unstable, at high risk of a complicated postoperative course. Red) in a critical condition with the risk of life-threatening complications</description>
    </other_outcome>
    <other_outcome>
      <measure>The association between the triage categories and deterioration and complications within 72 hours post-PACU discharge</measure>
      <time_frame>Up to 72 hours post PACU discharge or at hospital discharge (under 72 hours from PACU discharge)</time_frame>
      <description>Can PACU and ward nurses predict the outcome of the patient course within the first 72 hours post PACU discharge (within the defined triage categories describing the conditions)</description>
    </other_outcome>
    <other_outcome>
      <measure>Agreement between the PACU nurse' and ward nurses' triage</measure>
      <time_frame>Up to 72 hours post PACU discharge or at hospital discharge (under 72 hours from PACU discharge)</time_frame>
      <description>How aligned are the PACU and ward nurses' predictions within the first 72 hours post-PACU discharge or at hospital discharge? Alignment will be explored using kappa statistics</description>
    </other_outcome>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Postoperative Complications</condition>
    <condition>Deterioration, Clinical</condition>
    <condition>Postoperative Care</condition>
    <condition>Anesthesiology</condition>
    <eligibility>
      <study_pop>
        <textblock>
          We will include approximately 250 adults undergoing surgery for hip fracture, lower limb&#xD;
          amputation, open liver resection, open pancreatic and esophageal/gastric surgery, and open&#xD;
          or laparoscopic major abdominal surgery. The surgical patient categories are selected based&#xD;
          on types of surgery performed at the research sites, clinical experience, and well-known&#xD;
          high risks of postoperative morbidity and mortality.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Patients who wish to participate will sign a consent form. Baseline data will be obtained&#xD;
          on all eligible participants; however, the full registry will only be obtained for those&#xD;
          who permit us.&#xD;
  &#xD;
          To recruit participants, the surgical schedules will be screened on a daily basis by the&#xD;
          principal investigator and/or a member of the research team (VB).&#xD;
  &#xD;
          Data entry has been prepared in RedCap, a secure method of robust data collection. All data&#xD;
          entry will be reviewed and validated by LBH and VB. In case of discrepancies or&#xD;
          inconsistencies, senior members of the research team NBF or EKA will review data for&#xD;
          clarity and validation.&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
          -Adult patients undergoing surgery for a hip fracture, lower limb amputation, open liver&#xD;
          resection, open pancreatic, and esophageal/gastric surgery&#xD;
  &#xD;
          And&#xD;
  &#xD;
            -  Adult patients undergoing open or laparoscopic major abdominal surgery and orthopedic&#xD;
               surgery&#xD;
  &#xD;
            -  Surgery time over 2 hours&#xD;
  &#xD;
            -  American Society of Anesthesiologists (ASA) physical status classification system 3 -&#xD;
               4&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pre-planned fixed minimum PACU stay&#xD;
  &#xD;
            -  Planned intensive care unit (ICU) stay&#xD;
  &#xD;
            -  Terminally ill&#xD;
  &#xD;
            -  Incapable of giving informed consent&#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_official>
      <last_name>Lea B Hvidberg, RN, Ms.c.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dep. of Anesthesiology, Amager and Hvidovre University Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Eske K Aasvang, MD,Med.Sc.D.</last_name>
      <role>Study Chair</role>
      <affiliation>Centre for Cancer and Organ Diseases, Rigshospitalet, University Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Martin G Tolsgaard, MD,Med.Sc.D.</last_name>
      <role>Study Chair</role>
      <affiliation>CAMES Rigshospitalet and Department of Obstetrics, Rigshospitalet, University Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Nicolai B Foss, MD,Med.Sc.D.</last_name>
      <role>Study Chair</role>
      <affiliation>Department of Anesthesiology, Amager and Hvidovre University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lea B Hvidberg, RN, Ms.c.</last_name>
      <phone>004560100020</phone>
      <email>lea.baunegaard.hvidberg@regionh.dk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Nicolai B Foss, MD,Med.Sc.D</last_name>
      <phone>38622532</phone>
      <email>nicolai.bang.foss@regionh.dk</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Copenhagen University Hospital, Hvidovre</investigator_affiliation>
      <investigator_full_name>Lea Baunegaard Hvidberg</investigator_full_name>
      <investigator_title>Clinical Nurse Specialist, Ph.d-fellow</investigator_title>
    </responsible_party>
    <keyword>Postoperative Complications</keyword>
    <keyword>Deterioration, Clinical</keyword>
    <keyword>Postoperative Care</keyword>
    <keyword>Clinical assessment</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Postoperative Complications</mesh_term>
      <mesh_term>Clinical Deterioration</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All IPD that underlie results in a publication</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Data will be available starting 6 months after publication</ipd_time_frame>
      <ipd_access_criteria>Data can by shared by request to the principal researcher</ipd_access_criteria>
    </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/NCT06013891
  org study id: F-22045028
  nct id: NCT06013891
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This prospective observational research project aims to investigate how vital sign
        deterioration and complications within the (PACU) relate to early deterioration and
        complications in the surgical wards 72 hours post-PACU discharge.
  
        The participants studied will be high-risk surgical patients who will follow a normal
        postoperative course from the PACU to the surgical ward. The investigators seek to evaluate
        the association between deterioration and complications within the PACU with vital signs
        deterioration and complications in the surgical wards. Second, the investigators will explore
        how deterioration and complications affect PACU length of stay, morbidity, mortality, rapid
        response Teams call-outs (RRT) (Early warning score >7), extra medical patient supervision,
        and unplanned intensive care unit (ICU) admissions. The investigators will also examine the
        nurses' assessment of the patient's risk of deterioration and complications upon discharge
        from the PACU and admission to the surgical department.
  Postoperative complications are increasing and are an under-recognized cause of morbidity and
        mortality. While there has been significant attention to preoperative risk assessments for
        late postoperative complications and 30-day mortality, little attention has been paid to the
        PACU as a point of in-patient triage for early postoperative deterioration and complications.
        PACU to surgical ward discharge readiness is often based on a quantitative discharge score
        that does not account for the patient's physiological responses or distinguish between
        surgery type, age, and co-morbidities.
  
        The discharge score is a clinical decision-making tool that sets the frame for the patient's
        readiness for discharge and functions as a "one six fits all" system. However, this "one size
        fits all" approach may not be adequate as a discharge tool when discharging high-risk,
        fragile patients from the PACU. The current evidence on using criterion-based discharge
        scores and the connection with early postoperative deterioration and complications are absent
        and need further investigation.
  
        It is unclear whether early postoperative deterioration and complications can be predicted
        and assessed during PACU stay. Thus leaving a big potential for improvement in patient
        assessment and detection of early deterioration and complications, improving safe PACU
        discharge for high-risk fragile patients. Providing new knowledge on early postoperative
        deterioration and complications within high-risk, fragile patient groups could improve
        postoperative courses and patient safety.
  
        Statistical analysis plan Data is expected to be divided into two (or 3) consecutive studies.
  observational model: Cohort
  time perspective: Prospective
  measure: The incidence of deterioration and complications during PACU stay
  time frame: Up to four our days
  description: In accordance with ICH-GCP: any untoward medical occurrence that(...)
  Results in death
  Is life-threatening
  Requires inpatient hospitalization or causes prolongation of existing hospitalization
  Results in persistent or significant disability/incapacity
  Requires intervention to prevent permanent impairment or damage And/or severe deviating vital signs defined as outside normal thresholds.
  measure: The incidence of deterioration and complications during the first 72 hours post-PACU discharge and its association with deterioration and complication rates in the PACU
  time frame: Up to three days
  description: In accordance with ICH-GCP: any untoward medical occurrence that(...)
  Results in death
  Is life-threatening
  Requires inpatient hospitalization or causes prolongation of existing hospitalization
  Results in persistent or significant disability/incapacity
  Requires intervention to prevent permanent impairment or damage And/or severe deviating vital signs defined as outside normal thresholds.
  measure: The association between deterioration, complications, and PACU length of stay
  time frame: Up to 24 hours
  description: How are deterioration and/or complications associated with prolonged PACU stay PACU length of stay? (> 2 hours)
  measure: The association between individual PACU discharge score and early risk of deterioration and complications within 72 hours post-PACU discharge
  time frame: Up tp 72 hours
  description: Can the discharge score (modified Aldrete score/aggregated score of vital signs) be a predictive value (of high individual or high total score) for early risk of deterioration and complications
  measure: The percentages of RRT call-outs (Early warning score >7) within 72 hours post-PACU discharge
  time frame: Up to 72 hours post PACU discharge
  description: How many patients will experience an Early Warning Score >7 (Early warning score is an aggregated score of physiological parameter). At a high score of equal to or above 7, the RRT should be contacted)
  measure: The percentages of extra medical, surgical, or ICU supervision within 72 hours post-PACU discharge
  time frame: Up to 72 hours post PACU discharge
  description: How many patients will experience extra medical, surgical, or ICU supervision within 72 hours
  measure: The percentages of unexpected patient transfer to cardiology, the pulmonary department, or the ICU
  time frame: Up to four days from PACU admittance
  description: How many patients will experience unexpected transfer to cardiology, the pulmonary department, or the ICU
  measure: PACU nurse prediction (triage categories) of the patient course within 72 hours post-PACU discharge
  time frame: At PACU discharge to surgical ward (up to 24 hours from PACU admittance)
  description: The triage categories are; green) stable and uncomplicated postoperative course. Yellow) Potentially unstable with a risk of minor risk of a complicated postoperative course. Orange) Unstable, at high risk of a complicated postoperative course. Red) in a critical condition with the risk off life-threatening complications
  measure: Surgical ward nurse prediction (triage categories) of the patient course within 72 hours post-PACU discharge
  time frame: When the ward nurse receive the patient from the PACU (up to 24 hours of PACU admittance)
  description: What are the receiving ward nurse's clinical predictions of the patient course within 72 hours post-PACU discharge. The triage categories are; green) stable and uncomplicated postoperative course. Yellow) Potentially unstable with a risk of minor risk of a complicated postoperative course. Orange) Unstable, at high risk of a complicated postoperative course. Red) in a critical condition with the risk of life-threatening complications
  measure: The association between the triage categories and deterioration and complications within 72 hours post-PACU discharge
  time frame: Up to 72 hours post PACU discharge or at hospital discharge (under 72 hours from PACU discharge)
  description: Can PACU and ward nurses predict the outcome of the patient course within the first 72 hours post PACU discharge (within the defined triage categories describing the conditions)
  measure: Agreement between the PACU nurse' and ward nurses' triage
  time frame: Up to 72 hours post PACU discharge or at hospital discharge (under 72 hours from PACU discharge)
  description: How aligned are the PACU and ward nurses' predictions within the first 72 hours post-PACU discharge or at hospital discharge? Alignment will be explored using kappa statistics
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Lea B Hvidberg, RN, Ms.c.
  role: Principal Investigator
  affiliation: Dep. of Anesthesiology, Amager and Hvidovre University Hospital
  last name: Eske K Aasvang, MD,Med.Sc.D.
  role: Study Chair
  affiliation: Centre for Cancer and Organ Diseases, Rigshospitalet, University Hospital
  last name: Martin G Tolsgaard, MD,Med.Sc.D.
  role: Study Chair
  affiliation: CAMES Rigshospitalet and Department of Obstetrics, Rigshospitalet, University Hospital
  last name: Nicolai B Foss, MD,Med.Sc.D.
  role: Study Chair
  affiliation: Department of Anesthesiology, Amager and Hvidovre University Hospital
  last name: Lea B Hvidberg, RN, Ms.c.
  phone: 004560100020
  email: lea.baunegaard.hvidberg@regionh.dk
  last name: Nicolai B Foss, MD,Med.Sc.D
  phone: 38622532
  email: nicolai.bang.foss@regionh.dk
  responsible party type: Principal Investigator
  investigator affiliation: Copenhagen University Hospital, Hvidovre
  investigator full name: Lea Baunegaard Hvidberg
  investigator title: Clinical Nurse Specialist, Ph.d-fellow
  mesh term: Postoperative Complications
  mesh term: Clinical Deterioration
  sharing ipd: Yes
  ipd description: All IPD that underlie results in a publication
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Data will be available starting 6 months after publication
  ipd access criteria: Data can by shared by request to the principal researcher