Boston Children's Hospital Post Anesthesia Care Unit Outcomes Study

NCT ID: NCT02189642

Last Updated: 2017-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

643 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-13

Study Completion Date

2017-03-08

Brief Summary

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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.

Detailed Description

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Conditions

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Surgical Procedures, Operative

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Genito-Urinary/Urology Surgical Procedure Types

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

No interventions assigned to this group

Otolaryngology Surgical Procedure Types

Pediatric patients undergoing tonsil and/or adenoid removal, tympanostomy, tympanoplasty, and mastoidectomy.

No interventions assigned to this group

Orthopaedics Surgical Procedure Types

Patients undergoing hip and knee arthroscopies, hardware removal, and tendon lengthening.

No interventions assigned to this group

Plastic Surgery Surgical Procedure Type

Pediatric patients undergoing alveolar cleft repair.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joseph P. Cravero

Department of Anesthesiology, Senior Associate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-P00008050

Identifier Type: -

Identifier Source: org_study_id

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