SepsisNCT01760044
Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients
A study testing Tissue oxygenation monitoring in people with Sepsis and Shock, run by University of Michigan at 1 site in United States.
Trial summary
Investigators are conducting research about oxygen levels in the body and whether it is possible to use a device to measure oxygen in the body's tissues noninvasively, without blood draws or a catheter (a plastic tube placed in a vein). Read more about this study
- Who is it for?
- Ages 30 days to 18 years
- What is being tested?
- Tissue oxygenation monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Nov 2014
- Phase
- Interventional
- 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 30 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients admitted to the Pediatric Intensive Care Unit (PICU) or Pediatric Cardiothoracic Unit (PCTU)
- Age >30 days and <18 years -patients with a "high" central venous line (ie internal jugular, subclavian, peripherally inserted central catheter, broviac, port) capable of blood draw and with central venous catheter tip in the superior vena cava
Who cannot join
- Age <30 days or >18 years
- Known pregnancy or subsequently discovered pregnancy after admission
- Uncorrected cyanotic congenital heart disease
- Relative Exclusion Criteria:
- Oral trauma preventing placement of Raman StO2 oximeter probe or microcirculation video device
- Upper extremity trauma preventing placement of BEAM device
Trial locations and contacts
1 site in 1 country.
United States1 site
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109
About this study
Investigators are conducting research about oxygen levels in the body and whether it is possible to use a device to measure oxygen in the body's tissues noninvasively, without blood draws or a catheter (a plastic tube placed in a vein). Investigators would like to know how this device compares to standard measurements using blood from a catheter. This may help treat patients who may not be getting enough oxygen to their body.
Read the detailed description
Investigators will enroll patients in the pediatric intensive care unit who have an indwelling catheter that allows measurement of central venous oxygen saturation. Measurements of central venous oxygen saturation using blood oximetry will be compared with measures of tissue oxygenation at the buccal mucosa using a Raman spectroscopy tissue oximeter. Investigators will also measure the status of the sublingual microcirculation utilizing sidestream dark field microscopy. Basic demographic and clinical variables such as ongoing vasoactive infusions, mechanical ventilation, and laboratory data will also be collected.
- Being tested
- Tissue oxygenation monitoring
- Keywords
- tissue oxygenation, perfusion status
- Medical subject headings
- Sepsis, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue oxygenation monitoringDevice
Also called R-StO2 (Raman Tissue Oxygenation)
The device provides continuous measures with updates based on the previous 10 seconds worth of data. Data is continuously stored.
| Study group | Role | What they receive |
|---|---|---|
| Tissue oxygenation monitoring | Experimental | Tissue oxygenation monitoring Receives: Device: Tissue oxygenation monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
tissue oxygenation level as measured by raman spectroscopy device
Measurement of tissue oxygenation level as based upon raman spectroscopy device will be compared with standard measures from central venous oxygen saturation from central venous catheters.
Measured: The measures will occur twice within the first 24 hours of admission to the pediatric ICU and then whenever a central venous oxygen saturation is measured by the clinical care team until the patient is discharged from the pediatric ICU.
Secondary outcomes (2)
Microcirculation as recorded by sublingual video microcirculation recorder.
Two video clips will be recorded of the sublingual microcirculation in each patient within the first 24 hours of admission to the PICU.
Measured: Twice in the first 24 hours after PICU admission
Vital signs as recorded by Bioinformatically enabled armband monitor (BEAM)
Bioinformatically enabled armband monitor (BEAM) will be placed on the patient's upper extremity for the first 24 hours of their admission and will be subsequently removed. The data will be stored in the device and investigators and clinicians caring for subjects will be blinded to the device output as data is collected. The device continually captures physiologic data such as heart rate, ECG results, and temperature.
Measured: Continuous from PICU admission through 24 hours of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Kuo, University of Michigan
- Investigators
- Kevin Ward, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760044
- Sponsor's protocol ID
- NATP001
- Status last verified
- May 2017
- First submitted
- 28 Dec 2012
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Assessment of Tissue Perfusion Status in Critically Ill Pediatric Patients
- ClinicalTrials.gov ID
- NCT01760044
- Acronym / sponsor ID
- NATP001
- Keywords
- tissue oxygenation, perfusion status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 3 Jan 2013 (estimated)
- 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.
Investigators are conducting research about oxygen levels in the body and whether it is possible to use a device to measure oxygen in the body's tissues noninvasively, without blood draws or a catheter (a plastic tube placed in a vein). Investigators would like to know how this device compares to standard measurements using blood from a catheter. This may help treat patients who may not be getting enough oxygen to their body.
Detailed description
Investigators will enroll patients in the pediatric intensive care unit who have an indwelling catheter that allows measurement of central venous oxygen saturation. Measurements of central venous oxygen saturation using blood oximetry will be compared with measures of tissue oxygenation at the buccal mucosa using a Raman spectroscopy tissue oximeter. Investigators will also measure the status of the sublingual microcirculation utilizing sidestream dark field microscopy. Basic demographic and clinical variables such as ongoing vasoactive infusions, mechanical ventilation, and laboratory data will also be collected.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tissue oxygenation monitoring | Experimental | Device: Tissue oxygenation monitoringTissue oxygenation monitoring |
Who may qualify
- Ages
- 30 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients admitted to the Pediatric Intensive Care Unit (PICU) or Pediatric Cardiothoracic Unit (PCTU)
- Age >30 days and <18 years -patients with a "high" central venous line (ie internal jugular, subclavian, peripherally inserted central catheter, broviac, port) capable of blood draw and with central venous catheter tip in the superior vena cava
Key exclusion criteria (6 listed)
- Age <30 days or >18 years
- Known pregnancy or subsequently discovered pregnancy after admission
- Uncorrected cyanotic congenital heart disease
- Oral trauma preventing placement of Raman StO2 oximeter probe or microcirculation video device
- Upper extremity trauma preventing placement of BEAM device
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 |
|---|---|---|
| Tissue oxygenation monitoringAlso: R-StO2 (Raman Tissue Oxygenation)The device provides continuous measures with updates based on the previous 10 seconds worth of data. Data is continuously stored. | Device | Tissue oxygenation monitoring |
Primary outcome
tissue oxygenation level as measured by raman spectroscopy device
Time frame: The measures will occur twice within the first 24 hours of admission to the pediatric ICU and then whenever a central venous oxygen saturation is measured by the clinical care team until the patient is discharged from the pediatric ICU.
Measurement of tissue oxygenation level as based upon raman spectroscopy device will be compared with standard measures from central venous oxygen saturation from central venous catheters.
2 secondary outcomes
Microcirculation as recorded by sublingual video microcirculation recorder.
Time frame: Twice in the first 24 hours after PICU admission
Vital signs as recorded by Bioinformatically enabled armband monitor (BEAM)
Time frame: Continuous from PICU admission through 24 hours of admission
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 23 May 2017.
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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.
Kevin Ward, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue oxygenation monitoring in people with Sepsis and Shock, run by University of Michigan 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 2 inclusion and 6 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 23 May 2017. 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?
tissue oxygenation level as measured by raman spectroscopy device (time frame: The measures will occur twice within the first 24 hours of admission to the pediatric ICU and then whenever a central venous oxygen saturation is measured by the clinical care team until the patient is discharged from the pediatric ICU.). 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 23 May 2017.