<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/NCT02189642</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00008050</org_study_id>
    <nct_id>NCT02189642</nct_id>
  </id_info>
  <brief_title>Boston Children's Hospital Post Anesthesia Care Unit Outcomes Study</brief_title>
  <official_title>Evaluation of Perioperative Outcomes in Children: Creation of the Boston Children's Hospital Perioperative Outcomes Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the quality of outcomes in the Post Anesthesia Care&#xD;
      Unit (PACU) at BCH and to identify preoperative demographic and behavioral data as well as&#xD;
      intraoperative and anesthetic predictors of adverse PACU outcomes. The investigators&#xD;
      hypothesize quality of PACU outcomes will correlate with preoperative demographic and&#xD;
      behavioral characteristics as well as intraoperative and anesthetic procedures/techniques.&#xD;
      This study will help the investigators improve post anesthetic care quality and create a&#xD;
      higher level of satisfaction for patients, family, and health care providers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 13, 2013</start_date>
  <completion_date type="Actual">March 8, 2017</completion_date>
  <primary_completion_date type="Actual">March 8, 2017</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>Incidence of Significant Pain in PACU</measure>
    <time_frame>On day of surgery.</time_frame>
    <description>Incidence of significant pain defined by pain behavior information from the Faces-Legs-Activity-Cry-Consolability (FLACC) scale, Wong-Baker Faces scale, visual analog scale/numerical scale or adapted numerical rating scale - equal to or more than 5 on a scale from 0 to 10 at any time during the PACU stay.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Agitation in PACU</measure>
    <time_frame>On day of surgery.</time_frame>
    <description>Incidence of agitation using emergence agitation categorization with Pediatric Agitation Emergence Delirium (PAED) scale equal to or more than 10 on this scale for more than 30 seconds during the recovery period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Post-Operative Nausea or Vomiting</measure>
    <time_frame>On day of surgery.</time_frame>
    <description>Post-operative vomiting (POV) will be measured by episodes of vomiting or retching in PACU. This will be a binary outcome - either vomiting/retching occurred or it did not.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of Patients and Families with Post-Operative Care</measure>
    <time_frame>At two days and two weeks after surgery.</time_frame>
    <description>Satisfaction of patients and families with perioperative care, as determined from a three-question satisfaction survey allowing participating families to rate their recovery experience, global surgical experience, and need for further care at another healthcare facility.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-Hospitalization Behavior Changes</measure>
    <time_frame>At two days and two weeks after surgery.</time_frame>
    <description>Post-hospitalization behaviors changes defined by development of 4 or more behavior changes on the Post Hospitalization Behavior Questionnaire (PHBQ) or development of increased stress levels on the Child PTSD Symptom Scale (CPSS).</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">643</enrollment>
  <condition>Surgical Procedures, Operative</condition>
  <arm_group>
    <arm_group_label>Genito-Urinary/Urology Surgical Procedure Types</arm_group_label>
    <description>Pediatric patients undergoing circumcision, orchidopexy, hypospadias repair, hernia repair, cystoscopy, pyeloplasty, and ureteral reimplants or ureteral stents.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Otolaryngology Surgical Procedure Types</arm_group_label>
    <description>Pediatric patients undergoing tonsil and/or adenoid removal, tympanostomy, tympanoplasty, and mastoidectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Orthopaedics Surgical Procedure Types</arm_group_label>
    <description>Patients undergoing hip and knee arthroscopies, hardware removal, and tendon lengthening.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Plastic Surgery Surgical Procedure Type</arm_group_label>
    <description>Pediatric patients undergoing alveolar cleft repair.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The investigators will enroll all patients ages 6 months to 30 years undergoing the&#xD;
        following qualifying surgeries:&#xD;
&#xD;
        • Genito-Urinary/Urology Department&#xD;
&#xD;
        Circumcision, Orchidopexy, Hypospadias Repair, Hernia Repair, Cystoscopy, Pyeloplasty, and&#xD;
        Ureteral Reimplants or Ureteral Stents&#xD;
&#xD;
        • Otolaryngology Department&#xD;
&#xD;
        Tonsil and/or Adenoid Removal, Tympanostomy, Tympanoplasty, and Mastoidectomy&#xD;
&#xD;
        • Orthopaedics Department&#xD;
&#xD;
        Hip and Knee Arthroscopies, Hardware Removal, and Tendon Lengthening&#xD;
&#xD;
        • Plastic Surgery Department&#xD;
&#xD;
        Alveolar Cleft Repair&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients scheduled for surgery at Boston Children's Hospital ages 6 months to 30&#xD;
             years undergoing the following qualifying surgeries:&#xD;
&#xD;
        Genito-Urinary/Urology Department:&#xD;
&#xD;
          -  Circumcision, Orchidopexy, Hypospadias Repair, Hernia Repair, Cystoscopy, Pyeloplasty,&#xD;
             and Ureteral Reimplants or Ureteral Stents.&#xD;
&#xD;
        Otolaryngology Department:&#xD;
&#xD;
          -  Tonsil and/or Adenoid Removal, Tympanostomy, Tympanoplasty, and Mastoidectomy.&#xD;
&#xD;
        Orthopaedics Department:&#xD;
&#xD;
          -  Hip and Knee Arthroscopies, Hardware Removal, and Tendon Lengthening.&#xD;
&#xD;
          -  Plastic Surgery Department: Alveolar Cleft Repair.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  English as a second language.&#xD;
&#xD;
          -  &lt; 6 months, &gt; 21 or 30 (hip patients only).&#xD;
&#xD;
          -  Resident of a residential facility or ward of state.&#xD;
&#xD;
          -  Guardianship status unclear.&#xD;
&#xD;
          -  Not headed to the PACU post-operatively.&#xD;
&#xD;
          -  Day of: Projected to arrive in PACU after 3 PM.&#xD;
&#xD;
          -  Duration of surgery well beyond ordinary for procedure type.&#xD;
&#xD;
          -  Exceptionally complex medical history.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>March 8, 2017</last_update_submitted>
  <last_update_submitted_qc>March 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Joseph P. Cravero</investigator_full_name>
    <investigator_title>Department of Anesthesiology, Senior Associate</investigator_title>
  </responsible_party>
  <!-- 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/NCT02189642
org study id: IRB-P00008050
nct id: NCT02189642
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the quality of outcomes in the Post Anesthesia Care
      Unit (PACU) at BCH and to identify preoperative demographic and behavioral data as well as
      intraoperative and anesthetic predictors of adverse PACU outcomes. The investigators
      hypothesize quality of PACU outcomes will correlate with preoperative demographic and
      behavioral characteristics as well as intraoperative and anesthetic procedures/techniques.
      This study will help the investigators improve post anesthetic care quality and create a
      higher level of satisfaction for patients, family, and health care providers.
observational model: Cohort
time perspective: Prospective
measure: Incidence of Significant Pain in PACU
time frame: On day of surgery.
description: Incidence of significant pain defined by pain behavior information from the Faces-Legs-Activity-Cry-Consolability (FLACC) scale, Wong-Baker Faces scale, visual analog scale/numerical scale or adapted numerical rating scale - equal to or more than 5 on a scale from 0 to 10 at any time during the PACU stay.
measure: Incidence of Agitation in PACU
time frame: On day of surgery.
description: Incidence of agitation using emergence agitation categorization with Pediatric Agitation Emergence Delirium (PAED) scale equal to or more than 10 on this scale for more than 30 seconds during the recovery period.
measure: Incidence of Post-Operative Nausea or Vomiting
time frame: On day of surgery.
description: Post-operative vomiting (POV) will be measured by episodes of vomiting or retching in PACU. This will be a binary outcome - either vomiting/retching occurred or it did not.
measure: Satisfaction of Patients and Families with Post-Operative Care
time frame: At two days and two weeks after surgery.
description: Satisfaction of patients and families with perioperative care, as determined from a three-question satisfaction survey allowing participating families to rate their recovery experience, global surgical experience, and need for further care at another healthcare facility.
measure: Post-Hospitalization Behavior Changes
time frame: At two days and two weeks after surgery.
description: Post-hospitalization behaviors changes defined by development of 4 or more behavior changes on the Post Hospitalization Behavior Questionnaire (PHBQ) or development of increased stress levels on the Child PTSD Symptom Scale (CPSS).
arm group label: Genito-Urinary/Urology Surgical Procedure Types
description: Pediatric patients undergoing circumcision, orchidopexy, hypospadias repair, hernia repair, cystoscopy, pyeloplasty, and ureteral reimplants or ureteral stents.
arm group label: Otolaryngology Surgical Procedure Types
description: Pediatric patients undergoing tonsil and/or adenoid removal, tympanostomy, tympanoplasty, and mastoidectomy.
arm group label: Orthopaedics Surgical Procedure Types
description: Patients undergoing hip and knee arthroscopies, hardware removal, and tendon lengthening.
arm group label: Plastic Surgery Surgical Procedure Type
description: Pediatric patients undergoing alveolar cleft repair.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Months
maximum age: 30 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Joseph P. Cravero
investigator title: Department of Anesthesiology, Senior Associate