Posterior Spinal Fusion
Conditions
Brief summary
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).
Interventions
DEVICENIRS
Cerebral oxygenation monitor which is standard of care for this surgery.
Sponsors
Joseph D. Tobias
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Any patient undergoing spinal surgery
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cerebral Oxygenation Values Throughout the Procedure | prior to induction of anesthesia in the awake patient and following four ventilation strategies (average time frame of 15 mins. to 5 hours) | Measured on the NIRS cerebral oxygenation monitor attached to the patient |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Posterior Spinal Fusion Patients undergoing spinal fusion surgery
NIRS: Cerebral oxygenation monitor which is standard of care for this surgery. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Posterior Spinal Fusion | — |
|---|---|---|
| Age, Categorical <=18 years | 30 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 30 participants | — |
| Sex: Female, Male Female | 17 Participants | — |
| Sex: Female, Male Male | 13 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Change in Cerebral Oxygenation Values Throughout the Procedure
Measured on the NIRS cerebral oxygenation monitor attached to the patient
Time frame: prior to induction of anesthesia in the awake patient and following four ventilation strategies (average time frame of 15 mins. to 5 hours)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Posterior Spinal Fusion | Change in Cerebral Oxygenation Values Throughout the Procedure | Phase 1 | 83 rSO2 | Standard Deviation 8 |
| Posterior Spinal Fusion | Change in Cerebral Oxygenation Values Throughout the Procedure | Phase 2 | 79 rSO2 | Standard Deviation 8 |
| Posterior Spinal Fusion | Change in Cerebral Oxygenation Values Throughout the Procedure | Phase 3 | 81 rSO2 | Standard Deviation 9 |
| Posterior Spinal Fusion | Change in Cerebral Oxygenation Values Throughout the Procedure | Phase 4 | 83 rSO2 | Standard Deviation 8 |