Changes in Cerebral Oxygenation Related to Intraoperative Position Changes

NCT06910228 | Enrolling By Invitation

• 1 other identifier: STUDY00004900
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Scoliosis Patients

Outcome Measures

Primary Outcomes (2)

• Change in cerebral oxygenation at 30 degrees

  Moving the head of the bed to 30 degrees and comparing cerebral oxygen levels to levels when patient was lying flat.

  5-10 minutes after start of study

• Change in cerebral oxygenation at 60 degrees

  Moving the head of the bed to 60 degrees and comparing cerebral oxygen levels to levels when patient was lying flat.

  10-15 minutes after start of study

Interventions

Near infrared spectroscopy (NIRS) DEVICE

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

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients having surgery at Nationwide Children's Hospital.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joseph D. Tobias: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

Spectroscopy, Near-Infrared

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Joseph Tobias, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief - Department of Anesthesiology and Pain Medicine

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 4, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)