Surgical Procedures, OperativeNCT02189642
Boston Children's Hospital Post Anesthesia Care Unit Outcomes Study
An observational study of Surgical Procedures, Operative, run by Boston Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 months to 30 years
- Conditions the study is for
- Surgical Procedures, Operative
- How many people
- 643 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2013to 8 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: 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.
- Conditions
- Surgical Procedures, Operative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: On day of surgery.
Secondary outcomes (2)
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.
Measured: 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).
Measured: At two days and two weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study start13 Jul 2013
- Primary completion8 Mar 2017
- Study completion8 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedures, OperativeStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 643 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph P. Cravero, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189642
- Sponsor's protocol ID
- IRB-P00008050
- Status last verified
- Mar 2017
- First submitted
- 11 Jul 2014
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Perioperative Outcomes in Children: Creation of the Boston Children's Hospital Perioperative Outcomes Registry
- ClinicalTrials.gov ID
- NCT02189642
- Acronym / sponsor ID
- IRB-P00008050
- Conditions
- Surgical Procedures, Operative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 643 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 13 Jul 2013
- Primary completion
- 8 Mar 2017 (actual)
- Study completion
- 8 Mar 2017 (actual)
- First posted
- 14 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 months to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (8 listed)
- All patients scheduled for surgery at Boston Children's Hospital ages 6 months to 30 years undergoing the following qualifying surgeries:
- Circumcision, Orchidopexy, Hypospadias Repair, Hernia Repair, Cystoscopy, Pyeloplasty, and Ureteral Reimplants or Ureteral Stents.
- Tonsil and/or Adenoid Removal, Tympanostomy, Tympanoplasty, and Mastoidectomy.
- Hip and Knee Arthroscopies, Hardware Removal, and Tendon Lengthening.
- Plastic Surgery Department: Alveolar Cleft Repair.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
2 secondary outcomes
Satisfaction of Patients and Families with Post-Operative Care
Time frame: At two days and two weeks after surgery.
Post-Hospitalization Behavior Changes
Time frame: At two days and two weeks after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Procedures, Operative, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Significant Pain in PACU (time frame: On day of surgery.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2017.