Infants Undergoing SurgeryNCT02840253
Changes in Tissue and Cerebral Oxygenation Following Spinal Anesthesia in Neonates, Infants, and Children
A study testing NIRS in people with Infants Undergoing Surgery, run by Joseph D. Tobias.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Infants Undergoing Surgery
- What is being tested?
- NIRS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to 12 May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All patients that are candidates for and have agreed to spinal anesthesia.
Who cannot join
- none
About this study
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.
- Conditions
- Infants Undergoing Surgery
- Being tested
- NIRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRSDevice
| Study group | Role | What they receive |
|---|---|---|
| NIRS | Experimental | Non-invasive near infrared spectroscopy to assess changes in tissue and cerebral oxygenation. Receives: Device: NIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Intraoperative measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion12 May 2017
- Study completion12 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infants Undergoing SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph D. Tobias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joseph D. Tobias, Nationwide Children's Hospital
- Investigators
- Joseph Tobias, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840253
- Sponsor's protocol ID
- IRB16-00465
- Status last verified
- Aug 2018
- First submitted
- 23 Jun 2016
- Last updated
- 16 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29330639
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Tissue and Cerebral Oxygenation Following Spinal Anesthesia in Neonates, Infants, and Children
- ClinicalTrials.gov ID
- NCT02840253
- Acronym / sponsor ID
- IRB16-00465
- Conditions
- Infants Undergoing Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Joseph D. TobiasUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 12 May 2017 (actual)
- Study completion
- 12 May 2017 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Posted 16 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIRS | Experimental | Device: NIRSNon-invasive near infrared spectroscopy to assess changes in tissue and cerebral oxygenation. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All patients that are candidates for and have agreed to spinal anesthesia.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIRS | Device | NIRS |
Primary outcome
Cerebral Non-invasive Near Infrared Spectroscopy (NIRS)
Time frame: 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)
Time frame: Intraoperative measure
Change in tissue oxygen saturation from immediately after spinal anesthesia placement to conclusion of monitoring (30 mins post block).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29330639Froyshteter 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Tobias, MD principal investigator
Nationwide Children's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing NIRS in people with Infants Undergoing Surgery, run by Joseph D. Tobias.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral Non-invasive Near Infrared Spectroscopy (NIRS) (time frame: Intraoperative measure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02840253, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.