Boston Children's Hospital Post Anesthesia Care Unit Outcomes Study

Surgical Procedures, Operative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02189642
• Other study ID #: IRB-P00008050
• Status: Completed
• Phase: N/A
• First received: July 11, 2014
• Last updated: March 8, 2017
• Start date: July 13, 2013
• Est. completion date: March 8, 2017

Study information

• Verified date: March 2017
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 643
• Est. completion date: March 8, 2017
• Est. primary completion date: March 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Surgical Procedures, Operative

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.