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Boston Children's Hospital Post Anesthesia Care Unit Outcomes Study

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ClinicalTrials.gov Identifier: NCT02189642
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Joseph P. Cravero, Boston Children’s Hospital

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
Surgical Procedures, Operative

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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 : July 13, 2013
Actual Primary Completion Date : March 8, 2017
Actual Study Completion Date : March 8, 2017

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Incidence of Significant Pain in PACU [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).



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Ages Eligible for Study:   6 Months to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189642


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital

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Responsible Party: Joseph P. Cravero, Department of Anesthesiology, Senior Associate, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02189642     History of Changes
Other Study ID Numbers: IRB-P00008050
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017