Boston Children's Hospital Post Anesthesia Care Unit Outcomes Study

Evaluation of Perioperative Outcomes in Children: Creation of the Boston Children's Hospital Perioperative Outcomes Registry

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.

Study Overview

• Status: Completed
• Conditions: Surgical Procedures, Operative

• Study Type: Observational
• Enrollment (Actual): 643

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 30 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The investigators will enroll all patients 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Significant Pain in PACU	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.	On day of surgery.
Incidence of Agitation in PACU	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.	On day of surgery.
Incidence of Post-Operative Nausea or Vomiting	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.	On day of surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction of Patients and Families with Post-Operative Care	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.	At two days and two weeks after surgery.
Post-Hospitalization Behavior Changes	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).	At two days and two weeks after surgery.

Collaborators and Investigators

• Sponsor: Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start: July 13, 2013
• Primary Completion (ACTUAL): March 8, 2017
• Study Completion (ACTUAL): March 8, 2017

Study Registration Dates

• First Submitted: July 11, 2014
• First Submitted That Met QC Criteria: July 11, 2014
• First Posted (ESTIMATE): July 14, 2014

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: IRB-P00008050