Cardiovascular DiseasesNCT02754947
Need for the Assessment and Consultation Team (ACT) Following Anesthetic Care
An observational study of Cardiovascular Diseases and Respiratory Diseases, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
The goal of this study was to identify the etiology of events and demographics of patients that experience complications requiring activation of the Rapid Response Team (RRT) during the first 24 h following anesthetic care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Respiratory Diseases, Neurologic Diseases
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Mar 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any study subject that experienced an ACT following anesthetic administration during care at any Nationwide Children's Hospital facility reviewed from an existing Department of Anesthesiology \& Pain Medicine database.
Who may be able to join
- Any study subject that experienced an ACT following anesthetic administration during care at any Nationwide Children's Hospital facility.
Who cannot join
- Any study subject that has not experienced an ACT following anesthetic administration during care at any Nationwide Children's Hospital facility.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Etiology of Post-anesthetic and Post-sedation Events on the Inpatient Ward: Data From a Rapid Response Team at a Tertiary Care Children's Hospital
The goal of this study was to identify the etiology of events and demographics of patients that experience complications requiring activation of the Rapid Response Team (RRT) during the first 24 h following anesthetic care.
- Keywords
- Assessment and Consultation Team (ACT), Rapid Response Team (RRT), Perioperative complications, Respiratory insufficiency, ASA status
- Medical subject headings
- Cardiovascular Diseases, Respiratory Tract Diseases, Nervous System Diseases, Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying post-operative criteria for activation of Rapid Response Teams (RRTs) in caring for the pediatric population using Pediatric Early Warning Scores (PEWS)
To retrospectively identify the etiologies associated with a need to engage Rapid Response Teams (RRTs) to promote frequent assessments and early interventions among clinically deteriorating hospitalized pediatric patients.
Measured: 24 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Nationwide 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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- N'Diris Barry, BS, RN, MSN, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754947
- Sponsor's protocol ID
- IRB14-00946
- Status last verified
- Dec 2023
- First submitted
- 25 Apr 2016
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiology of Post-anesthetic and Post-sedation Events on the Inpatient Ward: Data From a Rapid Response Team at a Tertiary Care Children's Hospital
- ClinicalTrials.gov ID
- NCT02754947
- Acronym / sponsor ID
- IRB14-00946
- Keywords
- Assessment and Consultation Team (ACT), Rapid Response Team (RRT), Perioperative complications, Respiratory insufficiency, ASA status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 28 Apr 2016 (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 goal of this study was to identify the etiology of events and demographics of patients that experience complications requiring activation of the Rapid Response Team (RRT) during the first 24 h following anesthetic care.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any study subject that experienced an ACT following anesthetic administration during care at any Nationwide Children's Hospital facility reviewed from an existing Department of Anesthesiology \& Pain Medicine database.
Key inclusion criteria (1 listed)
- Any study subject that experienced an ACT following anesthetic administration during care at any Nationwide Children's Hospital facility.
Key exclusion criteria (1 listed)
- Any study subject that has not experienced an ACT following anesthetic administration during care at any Nationwide Children's Hospital facility.
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
Identifying post-operative criteria for activation of Rapid Response Teams (RRTs) in caring for the pediatric population using Pediatric Early Warning Scores (PEWS)
Time frame: 24 hours post-operatively
To retrospectively identify the etiologies associated with a need to engage Rapid Response Teams (RRTs) to promote frequent assessments and early interventions among clinically deteriorating hospitalized pediatric patients.
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 13 Dec 2023.
- Individual participant dataSharing planned: No
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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.
N'Diris Barry, BS, RN, MSN principal investigator
Nationwide Children's Hospital
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 Cardiovascular Diseases and Respiratory Diseases, run by Nationwide 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 1 inclusion and 1 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 13 Dec 2023. 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?
Identifying post-operative criteria for activation of Rapid Response Teams (RRTs) in caring for the pediatric population using Pediatric Early Warning Scores (PEWS) (time frame: 24 hours post-operatively). 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 13 Dec 2023.