Infants Undergoing Surgery
Conditions
Brief summary
Investigators have started an awake spinal anesthesia program in conjunction with pediatric surgical colleagues. Patients are offered the option of awake spinal anesthesia instead of general anesthesia for appropriate surgical procedures. Previous studies have demonstrated a lack of significant hemodynamic changes in neonates and infants following spinal anesthesia; however, there are limited data regarding its impact on tissue oxygenation. The goal of the current study is to assess changes in tissue and cerebral oxygenation using non-invasive near infrared spectroscopy following spinal anesthesia.
Interventions
DEVICENIRS
Sponsors
Joseph D. Tobias
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
No
Inclusion criteria
* All patients that are candidates for and have agreed to spinal anesthesia.
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral Non-invasive Near Infrared Spectroscopy (NIRS) | Intraoperative measure | Change in cerebral oxygen saturation from immediately after spinal anesthesia placement to conclusion of monitoring (30 mins post block). |
| Tissue Non-invasive Near Infrared Spectroscopy (NIRS) | Intraoperative measure | Change in tissue oxygen saturation from immediately after spinal anesthesia placement to conclusion of monitoring (30 mins post block). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NIRS Non-invasive near infrared spectroscopy to assess changes in tissue and cerebral oxygenation.
NIRS | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Unsuccessful block | 4 |
Baseline characteristics
| Characteristic | NIRS |
|---|---|
| Age, Continuous | 7 months STANDARD_DEVIATION 3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
Cerebral Non-invasive Near Infrared Spectroscopy (NIRS)
Change in cerebral oxygen saturation from immediately after spinal anesthesia placement to conclusion of monitoring (30 mins post block).
Time frame: Intraoperative measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NIRS | Cerebral Non-invasive Near Infrared Spectroscopy (NIRS) | 0.05 percentage change per minute |
Primary
Tissue Non-invasive Near Infrared Spectroscopy (NIRS)
Change in tissue oxygen saturation from immediately after spinal anesthesia placement to conclusion of monitoring (30 mins post block).
Time frame: Intraoperative measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NIRS | Tissue Non-invasive Near Infrared Spectroscopy (NIRS) | 0.04 percentage change per minute |