- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01934062
Induction Hypotension in Pediatric Population
May 14, 2015 updated by: Tariq Wani
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 Overview
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
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Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 8 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Surgical patients from Nationwide Children's Hosp.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with any cardiovascular or kidney diseases will be excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Surgical patients
Pediatric patients having surgery at Nationwide Children's Hosp. between 1/1/2013 & 7/31/2013.
|
All surgeries performed at Nationwide Children's Hosp. between 1/1/2013 & 7/31/2013. -------------------------------------------------------------------------------- |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hypotension
Time Frame: Baseline, 5, 10, & 15 mins. post induction
|
Measure the degree of change from pre-induction levels.
|
Baseline, 5, 10, & 15 mins. post induction
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
August 29, 2013
First Submitted That Met QC Criteria
August 29, 2013
First Posted (Estimate)
September 4, 2013
Study Record Updates
Last Update Posted (Estimate)
May 15, 2015
Last Update Submitted That Met QC Criteria
May 14, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- IRB13-00508
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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