PainNCT04362423
Functional Near Infrared Spectroscopy to Detect Pain in Young Children Under General Anesthesia
An observational study of Pain, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
This is a three-phase pilot prospective study to develop a devise capable of detecting changes in cortical blood volume and oxygenation due to noxious stimuli. The hypothesis of the study is that optical signal changes corresponding to blood volume and oxygenation will be detected with functional near infrared… Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Pain
- What is being tested?
- fNIRS
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 month to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: The patients who are presenting to CCHMC for tethered spinal cord release , posterior fossa decompression, or spine surgery; the anesthetic plan includes endotracheal intubation and neuromonitoring.
Who may be able to join
- They are presenting for tethered spinal cord release , posterior fossa decompression, or spine surgery;
- They are between 1 month to 16 years of age;
- Their anesthetic plan includes endotracheal intubation and neuromonitoring;
Who cannot join
- Patients with a known history of chronic pain;
- Patients with abnormal frontal lobe brain structure or abnormality of forehead precluding the fNIRS probe securement;
- Patients with a known allergy to fentanyl;
- Patients with unstable hemodynamics.
- Patients with a contraindication to the use of propofol
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: A Pilot Study to Evaluate Functional Near Infrared Spectroscopy to Detect Pain in Infants and Young Children Under General Anesthesia
This is a three-phase pilot prospective study to develop a devise capable of detecting changes in cortical blood volume and oxygenation due to noxious stimuli. The hypothesis of the study is that optical signal changes corresponding to blood volume and oxygenation will be detected with functional near infrared spectroscopy in the prefrontal cortex of children under general anesthesia in response to peripheral noxious stimuli produced from the neurophysiological monitoring (SSEP).
Read the detailed description
Pain is a subjective feeling, and an objective measure of pain is needed to obtain improved clinical management and safe outcomes of pain treatment. At present, there is a lack of specific physiological markers of acute pain that can guide analgesic treatment both during and after surgery. The anesthesiologist typically relies on hemodynamic variables to guide administration of opioids for surgical pain, but those parameters are not always either specific or sensitive. On the other hand, uncontrolled pain during surgery can lead to emotional distress and enhancement of the systemic inflammatory response (1).
Current evidence (2-4) shows that the prefrontal cortex plays an important role in pain perception and emotional elaboration. Functional neuroimaging (functional magnetic resonance imaging functional magnetic resonance imaging (fMRI) functional near infrared spectroscopy fNIRS) has been recently utilized to investigate cerebral pain-related activity (5, 6).
The investigators propose to detect the optical signal changes over the prefrontal cortex using fNIRS and diffuse optical imaging (DOI) in response to noxious electrical stimulation. This electrical stimulation will be applied over the ulnar nerve at the wrist in children undergoing neurosurgery with SSEP monitoring. This noxious electrical stimulation is the standard stimulus used to establish baseline somatosensory evoked potentials in this patient population for this surgery. DOI is a mathematical methodology used to generate an image from the optical signals analogous to the mathematical methodology of generating a MRI from nuclear magnetic spectroscopy signals.
The investigators will evaluate the magnitude of change of fNIRS-DOI signals after two different intensities of noxious electrical stimulation and following intravenous administration of fentanyl (2 mcg/kg). The investigators will also analyze the temporal correlation of the prefrontal cortex fNIRS-DOI changes with the SSEPs. The results will lead to the identification of an objective specific biomarker for acute pain in children. Our long-term goal is to develop a portable and readily accessible device to improve management of intraoperative nociception and to evaluate acute pain in awake non-verbal children.
- Conditions
- Pain
- Being tested
- fNIRS
- Keywords
- Acute pain measurement in children
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fNIRSDevice
Also called Functional Near Infrared Spectroscopy
Near infrared spectroscopy (NIRS) is a non-invasive, portable, relatively inexpensive optical technology similar to pulse oximetry except that it measures total hemoglobin, oxy-hemoglobin, and deoxyhemoglobin in brain tissue (capillaries) rather than arteries.
| Study group | Role | What they receive |
|---|---|---|
| propofol+fNIRS | During data collection, only propofol is used to maintain the anesthesia. Peripheral noxious stimuli produced from the neurophysiological monitoring (SSEP) Receives: Device: fNIRS | |
| sevoflurane+fNIRS | During data collection, only sevoflurane is used to maintain the anesthesia. Peripheral noxious stimuli produced from the neurophysiological monitoring (SSEP) Receives: Device: fNIRS | |
| neuro-stimulator+fNIRS | During data collection, we use neuro-stimulator to give the stimulation. Receives: Device: fNIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
the changes of oxy-, deoxy-, total-hemoglobin
Measured: during stimulation (16 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study startAug 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yifei Jiang, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362423
- Sponsor's protocol ID
- 2014-3578
- Status last verified
- Aug 2020
- First submitted
- 12 Aug 2015
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Functional Near Infrared Spectroscopy to Detect Pain in Infants and Young Children Under General Anesthesia
- ClinicalTrials.gov ID
- NCT04362423
- Acronym / sponsor ID
- 2014-3578
- Conditions
- Pain
- Keywords
- Acute pain measurement in children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a three-phase pilot prospective study to develop a devise capable of detecting changes in cortical blood volume and oxygenation due to noxious stimuli. The hypothesis of the study is that optical signal changes corresponding to blood volume and oxygenation will be detected with functional near infrared spectroscopy in the prefrontal cortex of children under general anesthesia in response to peripheral noxious stimuli produced from the neurophysiological monitoring (SSEP).
Detailed description
Pain is a subjective feeling, and an objective measure of pain is needed to obtain improved clinical management and safe outcomes of pain treatment. At present, there is a lack of specific physiological markers of acute pain that can guide analgesic treatment both during and after surgery. The anesthesiologist typically relies on hemodynamic variables to guide administration of opioids for surgical pain, but those parameters are not always either specific or sensitive. On the other hand, uncontrolled pain during surgery can lead to emotional distress and enhancement of the systemic inflammatory response (1).
Current evidence (2-4) shows that the prefrontal cortex plays an important role in pain perception and emotional elaboration. Functional neuroimaging (functional magnetic resonance imaging functional magnetic resonance imaging (fMRI) functional near infrared spectroscopy fNIRS) has been recently utilized to investigate cerebral pain-related activity (5, 6).
The investigators propose to detect the optical signal changes over the prefrontal cortex using fNIRS and diffuse optical imaging (DOI) in response to noxious electrical stimulation. This electrical stimulation will be applied over the ulnar nerve at the wrist in children undergoing neurosurgery with SSEP monitoring. This noxious electrical stimulation is the standard stimulus used to establish baseline somatosensory evoked potentials in this patient population for this surgery. DOI is a mathematical methodology used to generate an image from the optical signals analogous to the mathematical methodology of generating a MRI from nuclear magnetic spectroscopy signals.
The investigators will evaluate the magnitude of change of fNIRS-DOI signals after two different intensities of noxious electrical stimulation and following intravenous administration of fentanyl (2 mcg/kg). The investigators will also analyze the temporal correlation of the prefrontal cortex fNIRS-DOI changes with the SSEPs. The results will lead to the identification of an objective specific biomarker for acute pain in children. Our long-term goal is to develop a portable and readily accessible device to improve management of intraoperative nociception and to evaluate acute pain in awake non-verbal children.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| propofol+fNIRS | – | Device: fNIRSDuring data collection, only propofol is used to maintain the anesthesia. Peripheral noxious stimuli produced from the neurophysiological monitoring (SSEP) |
| sevoflurane+fNIRS | – | Device: fNIRSDuring data collection, only sevoflurane is used to maintain the anesthesia. Peripheral noxious stimuli produced from the neurophysiological monitoring (SSEP) |
| neuro-stimulator+fNIRS | – | Device: fNIRSDuring data collection, we use neuro-stimulator to give the stimulation. |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The patients who are presenting to CCHMC for tethered spinal cord release , posterior fossa decompression, or spine surgery; the anesthetic plan includes endotracheal intubation and neuromonitoring.
Key inclusion criteria (3 listed)
- They are presenting for tethered spinal cord release , posterior fossa decompression, or spine surgery;
- They are between 1 month to 16 years of age;
- Their anesthetic plan includes endotracheal intubation and neuromonitoring;
Key exclusion criteria (5 listed)
- Patients with a known history of chronic pain;
- Patients with abnormal frontal lobe brain structure or abnormality of forehead precluding the fNIRS probe securement;
- Patients with a known allergy to fentanyl;
- Patients with unstable hemodynamics.
- Patients with a contraindication to the use of propofol
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 |
|---|---|---|
| fNIRSAlso: Functional Near Infrared SpectroscopyNear infrared spectroscopy (NIRS) is a non-invasive, portable, relatively inexpensive optical technology similar to pulse oximetry except that it measures total hemoglobin, oxy-hemoglobin, and deoxyhemoglobin in brain tissue (capillaries) rather than arteries. | Device | neuro-stimulator+fNIRS, propofol+fNIRS, sevoflurane+fNIRS |
Primary outcome
the changes of oxy-, deoxy-, total-hemoglobin
Time frame: during stimulation (16 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
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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.
Yifei Jiang principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 3 inclusion and 5 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 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the changes of oxy-, deoxy-, total-hemoglobin (time frame: during stimulation (16 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2020.