Scoliosis PatientsNCT06910228
Changes in Cerebral Oxygenation Related to Intraoperative Position Changes
An observational study of Scoliosis Patients, run by Joseph D. Tobias at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Scoliosis Patients
- What is being tested?
- Near infrared spectroscopy (NIRS)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients having surgery at Nationwide Children's Hospital.
Who may be able to join
- Patients 10-21 years of age undergoing posterior spinal fusion, requiring neurophysiologic monitoring and an arterial cannula
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
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
- Being tested
- Near infrared spectroscopy (NIRS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near infrared spectroscopy (NIRS)Device
A non-invasive technique that uses light to assess brain function and tissue oxygenation.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10-15 minutes after start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start8 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joseph D. Tobias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joseph D. Tobias, Nationwide Children's Hospital
- Investigators
- Joseph Tobias, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910228
- Sponsor's protocol ID
- STUDY00004900
- Status last verified
- Oct 2025
- First submitted
- 2 Apr 2025
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Cerebral Oxygenation Related to Intraoperative Position Changes
- ClinicalTrials.gov ID
- NCT06910228
- Acronym / sponsor ID
- STUDY00004900
- Conditions
- Scoliosis Patients
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Joseph D. TobiasUniversity, hospital or other
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients having surgery at Nationwide Children's Hospital.
Key inclusion criteria (1 listed)
- Patients 10-21 years of age undergoing posterior spinal fusion, requiring neurophysiologic monitoring and an arterial cannula
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near infrared spectroscopy (NIRS)A non-invasive technique that uses light to assess brain function and tissue oxygenation. | Device | – |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph Tobias, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis Patients, run by Joseph D. Tobias at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cerebral oxygenation at 30 degrees (time frame: 5-10 minutes after start of study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.