Changes in Tissue and Cerebral Oxygenation Following Spinal Anesthesia in Neonates, Infants, and Children
1 other identifier
interventional
23
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedFirst Posted
Study publicly available on registry
July 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 12, 2017
CompletedResults Posted
Study results publicly available
August 16, 2018
CompletedAugust 16, 2018
August 1, 2018
11 months
June 23, 2016
June 5, 2018
August 15, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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).
Intraoperative measure
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).
Intraoperative measure
Study Arms (1)
NIRS
EXPERIMENTALNon-invasive near infrared spectroscopy to assess changes in tissue and cerebral oxygenation.
Interventions
Eligibility Criteria
You may qualify if:
- All patients that are candidates for and have agreed to spinal anesthesia.
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Joseph D. Tobiaslead
Related Publications (1)
Froyshteter AB, Tumin D, Whitaker EE, Martin DP, Hakim M, Walia H, Bhalla T, Tobias JD. Changes in tissue and cerebral oxygenation following spinal anesthesia in infants: a prospective study. J Anesth. 2018 Apr;32(2):288-292. doi: 10.1007/s00540-017-2446-8. Epub 2018 Jan 12.
PMID: 29330639DERIVED
Results Point of Contact
- Title
- Joseph D. Tobias, MD
- Organization
- Nationwide Children's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Tobias, MD
Nationwide Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chairman, Dept. of Anesthesiology & Pain Medicine
Study Record Dates
First Submitted
June 23, 2016
First Posted
July 21, 2016
Study Start
July 1, 2016
Primary Completion
May 12, 2017
Study Completion
May 12, 2017
Last Updated
August 16, 2018
Results First Posted
August 16, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share