- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02651103
Changes in Cerebral Oxygenation Based on Intraoperative Ventilation Strategy
The proposed research aims to investigate how different ventilation strategies may affect cerebral tissue oxygenation in the pediatric population. It will contribute to the literature exploring the NIRS monitoring device which is becoming increasingly utilized in a variety of anesthetic and critical care settings. It may help to guide clinical practice regarding optimal ventilation strategies, and how ventilation may be altered to correct suboptimal cerebral tissue oxygenation.
This prospective study will include 50 patients undergoing posterior spinal fusion that requires placement of an arterial cannulation. There will be no change in the anesthetic or perioperative care of these patients. Tissue and cerebral oxygenation will be monitored using near infrared spectroscopy (NIRS).
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Any patient undergoing spinal surgery
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Posterior spinal fusion
Patients undergoing spinal fusion surgery
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Cerebral oxygenation monitor which is standard of care for this surgery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Cerebral Oxygenation Values Throughout the Procedure
Time Frame: prior to induction of anesthesia in the awake patient and following four ventilation strategies (average time frame of 15 mins. to 5 hours)
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Measured on the NIRS cerebral oxygenation monitor attached to the patient
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prior to induction of anesthesia in the awake patient and following four ventilation strategies (average time frame of 15 mins. to 5 hours)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB15-01073
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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