Pediatric Surgical PatientsNCT01934062
Induction Hypotension in Pediatric Population
An observational study of Pediatric Surgical Patients, run by Tariq Wani at 1 site in United States.
Trial summary
This is a retrospective chart review to assess the incidence and the degree of blood pressure changes after induction of anesthesia and to study the effect of different induction agents on blood pressure. Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Pediatric Surgical Patients
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Aug 2014
- 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 1 year to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: Surgical patients from Nationwide Children's Hosp.
Who may be able to join
- Patients between ages of 1 year to 8 years will be included in the study.
- Patients with ASA physical classification 1 and 2 will be studied.
Who cannot join
- Patients with any cardiovascular or kidney diseases will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
This is a retrospective chart review to assess the incidence and the degree of blood pressure changes after induction of anesthesia and to study the effect of different induction agents on blood pressure.
- Conditions
- Pediatric Surgical Patients
- Being tested
- Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
All surgeries performed at Nationwide Children's Hosp. between 1/1/2013 \& 7/31/2013.
--------------------------------------------------------------------------------
| Study group | Role | What they receive |
|---|---|---|
| Surgical patients | Pediatric patients having surgery at Nationwide Children's Hosp. between 1/1/2013 \& 7/31/2013. Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotension
Measure the degree of change from pre-induction levels.
Measured: Baseline, 5, 10, & 15 mins. post induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Surgical PatientsStudies of the same condition, open and under way.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tariq Wani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tariq Wani, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934062
- Sponsor's protocol ID
- IRB13-00508
- Status last verified
- May 2015
- First submitted
- 29 Aug 2013
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction Hypotension in Pediatric Population
- ClinicalTrials.gov ID
- NCT01934062
- Acronym / sponsor ID
- IRB13-00508
- Conditions
- Pediatric Surgical Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Tariq WaniUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 4 Sep 2013 (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.
This is a retrospective chart review to assess the incidence and the degree of blood pressure changes after induction of anesthesia and to study the effect of different induction agents on blood pressure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical patients | – | Procedure: SurgeryPediatric patients having surgery at Nationwide Children's Hosp. between 1/1/2013 \& 7/31/2013. |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Surgical patients from Nationwide Children's Hosp.
Key inclusion criteria (2 listed)
- Patients between ages of 1 year to 8 years will be included in the study.
- Patients with ASA physical classification 1 and 2 will be studied.
Key exclusion criteria (1 listed)
- Patients with any cardiovascular or kidney diseases will be excluded from the study.
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 |
|---|---|---|
| SurgeryAll surgeries performed at Nationwide Children's Hosp. between 1/1/2013 \& 7/31/2013. -------------------------------------------------------------------------------- | Procedure or surgery | Surgical patients |
Primary outcome
Hypotension
Time frame: Baseline, 5, 10, & 15 mins. post induction
Measure the degree of change from pre-induction levels.
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 15 May 2015.
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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 Pediatric Surgical Patients, run by Tariq Wani 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: finished, as of the sponsor's last update on 15 May 2015. 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?
Hypotension (time frame: Baseline, 5, 10, & 15 mins. post induction). 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 15 May 2015; AzTrials last refreshed its copy on 4 Nov 2026.