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OpenTrials
Enrolling by Invitation

NCT Number: NCT06910228

Changes in Cerebral Oxygenation Related to Intraoperative Position Changes

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.

Enrolling by Invitation

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Key information

Conditions

Age range

10 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Near Infrared Spectroscopy (NIRS)

Device

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

Primary outcomes

  1. Change in cerebral oxygenation at 30 degrees

    Time frame: 5-10 minutes after start of study

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

  2. Change in cerebral oxygenation at 60 degrees

    Time frame: 10-15 minutes after start of study

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

Sponsors and collaborators

Lead sponsor

Joseph D. Tobias

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 4, 2025
Registry last updated
Oct 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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