Trial Outcomes & Findings for Changes in Tissue and Cerebral Oxygenation Following Spinal Anesthesia in Neonates, Infants, and Children (NCT NCT02840253)

Last Updated: 2018-08-16

Results Overview

Change in cerebral oxygen saturation from immediately after spinal anesthesia placement to conclusion of monitoring (30 mins post block).

Recruitment status

COMPLETED

Study phase

Target enrollment

23 participants

Primary outcome timeframe

Intraoperative measure

Results posted on

2018-08-16

Participant milestones
Measure	NIRS Non-invasive near infrared spectroscopy to assess changes in tissue and cerebral oxygenation. NIRS
Overall Study STARTED	23
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	4

Reasons for withdrawal
Measure	NIRS Non-invasive near infrared spectroscopy to assess changes in tissue and cerebral oxygenation. NIRS
Overall Study Unsuccessful block	4

Changes in Tissue and Cerebral Oxygenation Following Spinal Anesthesia in Neonates, Infants, and Children

Baseline characteristics by cohort
Measure	NIRS n=19 Participants Non-invasive near infrared spectroscopy to assess changes in tissue and cerebral oxygenation. NIRS
Age, Continuous	7 months STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

Timeframe: Intraoperative measure

Change in cerebral oxygen saturation from immediately after spinal anesthesia placement to conclusion of monitoring (30 mins post block).

Outcome measures
Measure	NIRS n=19 Participants Non-invasive near infrared spectroscopy to assess changes in tissue and cerebral oxygenation. NIRS
Cerebral Non-invasive Near Infrared Spectroscopy (NIRS)	0.05 percentage change per minute Interval -0.1 to 0.19

Timeframe: Intraoperative measure

Change in tissue oxygen saturation from immediately after spinal anesthesia placement to conclusion of monitoring (30 mins post block).

Outcome measures
Measure	NIRS n=19 Participants Non-invasive near infrared spectroscopy to assess changes in tissue and cerebral oxygenation. NIRS
Tissue Non-invasive Near Infrared Spectroscopy (NIRS)	0.04 percentage change per minute Interval 0.01 to 0.08

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Nationwide Children's Hospital

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