SurgeryNCT03436667
Perioperative Factors Impacting Surgical Risk and Outcomes in Children
An observational study of Surgery and Orthopedic Disorder, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
This prospective study will measure various factors in children coming in for ambulatory surgery and attempt to create a scoring system that would be able to predict post-operative outcomes. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Surgery, Orthopedic Disorder
- What is being tested?
- Spirometry and Reaction Time
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2018to 1 Jun 2022
- 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 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients undergoing ambulatory orthopedic surgery at Nationwide Children's Hospital.
Who may be able to join
- Pediatric patients aged 6-18 years old having ambulatory orthopedic surgery with or without planned postoperative admission.
- Patients need to be cooperative to under spirometry testing and reaction time measurement. If unable to perform, we will assess why they were not able (non-cooperative, inability, etc)
Who cannot join
- Spinal fusion
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
This prospective study will measure various factors in children coming in for ambulatory surgery and attempt to create a scoring system that would be able to predict post-operative outcomes.
- Conditions
- Surgery, Orthopedic Disorder
- Being tested
- Spirometry, Reaction Time
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirometryDiagnostic test
Lung volumes will be measured using spirometry.
Reaction TimeDiagnostic test
PVT-192 Psychomotor Vigilance Task Monitor is a hand-held, self-contained system used for repetitive reaction time measurement.
| Study group | Role | What they receive |
|---|---|---|
| Orthopedic surgery | Pediatric patients presenting for ambulatory orthopedic procedures Receives: Diagnostic Test: Spirometry; Diagnostic Test: Reaction Time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-anesthesia care unit (PACU) length of stay
The investigators hypothesize that spirometry performance will be associated with reduced PACU length of stay
Measured: Immediately post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start19 Sep 2018
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Why it stopped: PI left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vidya Raman, Nationwide Children's Hospital
- Investigators
- Vidya Raman, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436667
- Sponsor's protocol ID
- IRB18-00068
- Status last verified
- Sep 2022
- First submitted
- 12 Feb 2018
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Factors Impacting Surgical Risk and Outcomes in Children
- ClinicalTrials.gov ID
- NCT03436667
- Acronym / sponsor ID
- IRB18-00068
- Conditions
- Surgery, Orthopedic Disorder
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 19 Feb 2018 (actual)
- 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.
This prospective study will measure various factors in children coming in for ambulatory surgery and attempt to create a scoring system that would be able to predict post-operative outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthopedic surgery | – | Diagnostic Test: Spirometry, Diagnostic Test: Reaction TimePediatric patients presenting for ambulatory orthopedic procedures |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients undergoing ambulatory orthopedic surgery at Nationwide Children's Hospital.
Key inclusion criteria (2 listed)
- Pediatric patients aged 6-18 years old having ambulatory orthopedic surgery with or without planned postoperative admission.
- Patients need to be cooperative to under spirometry testing and reaction time measurement. If unable to perform, we will assess why they were not able (non-cooperative, inability, etc)
Key exclusion criteria (1 listed)
- Spinal fusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpirometryLung volumes will be measured using spirometry. | Diagnostic test | Orthopedic surgery |
| Reaction TimePVT-192 Psychomotor Vigilance Task Monitor is a hand-held, self-contained system used for repetitive reaction time measurement. | Diagnostic test | Orthopedic surgery |
Primary outcome
Post-anesthesia care unit (PACU) length of stay
Time frame: Immediately post-op
The investigators hypothesize that spirometry performance will be associated with reduced PACU length of stay
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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.
Vidya Raman, MD 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 Surgery and Orthopedic Disorder, 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 2 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: withdrawn, as of the sponsor's last update on 14 Sep 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Post-anesthesia care unit (PACU) length of stay (time frame: Immediately post-op). 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 14 Sep 2022.