Changes in Cerebral Oxygenation Related to Intraoperative Position Changes

NCT ID: NCT06910228

Last Updated: 2025-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-08

Study Completion Date

2026-12-31

Brief Summary

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This is a prospective, observational study. This study will assess the effect of temporary changes in body position (supine, head of bed elevated 30 degrees, head of bed elevated 60 degrees) in anesthetized patients. Tissue oxygenation will be assessed non-invasively using near infrared spectroscopy (NIRS) by a device that is used in our operating rooms and the ICU setting to assess cerebral and tissue oxygenation.

Detailed Description

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Conditions

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Scoliosis Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Near infrared spectroscopy (NIRS)

A non-invasive technique that uses light to assess brain function and tissue oxygenation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients 10-21 years of age undergoing posterior spinal fusion, requiring neurophysiologic monitoring and an arterial cannula

Exclusion Criteria

* Patients in whom an arterial cannula is not indicated for the surgical procedure
* Patients with comorbid conditions that may impact cerebral blood flow, cerebral perfusion or place them at risk for cerebral hypoperfusion
* Patients in whom an invasive arterial cannula cannot be placed
Minimum Eligible Age

10 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Joseph D. Tobias

OTHER

Sponsor Role lead

Responsible Party

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Joseph D. Tobias

Chief - Department of Anesthesiology and Pain Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Joseph Tobias, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00004900

Identifier Type: -

Identifier Source: org_study_id

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