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The proposed research aims to investigate how different ventilation strategies may affect cerebral tissue oxygenation in the pediatric population. It will contribute to the literature exploring the NIRS monitoring device which is becoming increasingly utilized in a variety of anesthetic and critical care settings. It may help to guide clinical practice regarding optimal ventilation strategies, and how ventilation may be altered to correct suboptimal cerebral tissue oxygenation.
This prospective study will include 50 patients undergoing posterior spinal fusion that requires placement of an arterial cannulation. There will be no change in the anesthetic or perioperative care of these patients. Tissue and cerebral oxygenation will be monitored using near infrared spectroscopy (NIRS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Posterior spinal fusion | Patients undergoing spinal fusion surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIRS | Device | Cerebral oxygenation monitor which is standard of care for this surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cerebral Oxygenation Values Throughout the Procedure | Measured on the NIRS cerebral oxygenation monitor attached to the patient | prior to induction of anesthesia in the awake patient and following four ventilation strategies (average time frame of 15 mins. to 5 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing posterior spinal fusion
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| Name | Affiliation | Role |
|---|---|---|
| Joseph D Tobias, MD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Posterior Spinal Fusion | Patients undergoing spinal fusion surgery NIRS: Cerebral oxygenation monitor which is standard of care for this surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Posterior Spinal Fusion | Patients undergoing spinal fusion surgery NIRS: Cerebral oxygenation monitor which is standard of care for this surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Cerebral Oxygenation Values Throughout the Procedure | Measured on the NIRS cerebral oxygenation monitor attached to the patient | Posted | Mean | Standard Deviation | rSO2 | prior to induction of anesthesia in the awake patient and following four ventilation strategies (average time frame of 15 mins. to 5 hours) |
|
|
through study completion, an average of 2 years
All-Cause Mortality, Serious, or Other (non-serious) Adverse Events were monitored/assessed, but none observed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Posterior Spinal Fusion | Patients undergoing spinal fusion surgery NIRS: Cerebral oxygenation monitor which is standard of care for this surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Coordinator | Nationwide Children's Hospital | 6147222997 | heather.dellinger@nationwidechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 15, 2017 | Dec 14, 2017 | Prot_SAP_000.pdf |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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