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Boston Children's Hospital Post Anesthesia Care Unit Outcomes Study

Sponsor
Boston Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02189642
Collaborator
(none)
643
Enrollment
1
Location
43.8
Duration (Months)
14.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    643 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Perioperative Outcomes in Children: Creation of the Boston Children's Hospital Perioperative Outcomes Registry
    Study Start Date :
    Jul 13, 2013
    Actual Primary Completion Date :
    Mar 8, 2017
    Actual Study Completion Date :
    Mar 8, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Genito-Urinary/Urology Surgical Procedure Types

    Pediatric patients undergoing circumcision, orchidopexy, hypospadias repair, hernia repair, cystoscopy, pyeloplasty, and ureteral reimplants or ureteral stents.
    Otolaryngology Surgical Procedure Types

    Pediatric patients undergoing tonsil and/or adenoid removal, tympanostomy, tympanoplasty, and mastoidectomy.
    Orthopaedics Surgical Procedure Types

    Patients undergoing hip and knee arthroscopies, hardware removal, and tendon lengthening.
    Plastic Surgery Surgical Procedure Type

    Pediatric patients undergoing alveolar cleft repair.

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Significant Pain in PACU [On day of surgery.]

      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.

    2. Incidence of Agitation in PACU [On day of surgery.]

      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.

    3. Incidence of Post-Operative Nausea or Vomiting [On day of surgery.]

      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.

    Secondary Outcome Measures

    1. Satisfaction of Patients and Families with Post-Operative Care [At two days and two weeks after surgery.]

      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.

    2. Post-Hospitalization Behavior Changes [At two days and two weeks after surgery.]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients scheduled for surgery at Boston Children's Hospital ages 6 months to 30 years undergoing the following qualifying surgeries:
    Genito-Urinary/Urology Department:
    • Circumcision, Orchidopexy, Hypospadias Repair, Hernia Repair, Cystoscopy, Pyeloplasty, and Ureteral Reimplants or Ureteral Stents.
    Otolaryngology Department:
    • Tonsil and/or Adenoid Removal, Tympanostomy, Tympanoplasty, and Mastoidectomy.
    Orthopaedics Department:

    • Hip and Knee Arthroscopies, Hardware Removal, and Tendon Lengthening.

    • Plastic Surgery Department: Alveolar Cleft Repair.

    Exclusion Criteria:

    • English as a second language.

    • < 6 months, > 21 or 30 (hip patients only).

    • Resident of a residential facility or ward of state.

    • Guardianship status unclear.

    • Not headed to the PACU post-operatively.

    • Day of: Projected to arrive in PACU after 3 PM.

    • Duration of surgery well beyond ordinary for procedure type.

    • Exceptionally complex medical history.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Boston Children's Hospital Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Boston Children's Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Joseph P. Cravero, Department of Anesthesiology, Senior Associate, Boston Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT02189642
    Other Study ID Numbers:
    • IRB-P00008050
    First Posted:
    Jul 14, 2014
    Last Update Posted:
    Mar 10, 2017
    Last Verified:
    Mar 1, 2017

    Study Results

    No Results Posted as of Mar 10, 2017