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Enrolling by invitation NCT06910228

Changes in Cerebral Oxygenation Related to Intraoperative Position Changes

— Observational Scoliosis Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Near infrared spectroscopy (NIRS).
Who it may be relevant to
Registry conditions: Scoliosis Patients. Basic parameters: 10 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Near infrared spectroscopy (NIRS)
    A non-invasive technique that uses light to assess brain function and tissue oxygenation.

Primary outcome measures

  • Change in cerebral oxygenation at 30 degrees [Time frame: 5-10 minutes after start of study]
  • Change in cerebral oxygenation at 60 degrees [Time frame: 10-15 minutes after start of study]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Nationwide Children's Hospital — Columbus

Identifiers

NCT: NCT06910228 · STUDY00004900

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗