ShockNCT03701646
ClearSight Validation in Pediatrics
An observational study of Shock and Hypotension and Shock, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
Specific aim 1: The specific aim of this study is to compare cardiac output measurements as well as cardiac index, and stroke volume obtained via thermodilution during a cardiac catheterization with data obtained by the ClearSight cardiac output monitoring system. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Shock, Hypotension and Shock
- What is being tested?
- Measurement by Clearsight device
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2017to 1 Jun 2019
- 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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients admitted to the ICU requiring an arterial line, or patients undergoing cardiac output measurements by cardiac catheterization by thermodilution.
Arm 1) Cardiac output measurements Patients will be selected as potential study participants from the patients undergoing cardiac catheterization in the Nemours Cardiac Center for medically indicated reasons.
Patients selected should meet the following criteria:
- Age 17 years old or younger
- Receiving a cardiac catheterization, including cardiac output measurement, for clinical purposes, as determined by their cardiologist
- Hemodynamically stable with a scheduled non-emergent catheterization
Patients will be excluded from this study if:
- have digits too small to effectively fit into the smallest ClearSight finger probe
- Are hemodynamically unstable
Arm 2) Arterial blood pressure measurements
Patients will be selected as potential study participants from the patients admitted to the pediatric intensive care unit and now requiring an arterial line for medically indicated reasons.
Patients selected should meet the following criteria:
- Age 17 years old or younger
Patients will be excluded from this study if:
- Have digits too small to effectively fit into the smallest ClearSight finger probe
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours A.I. duPont Hospital for Children
Wilmington, Delaware, 19805
About this study
Official title: Comparing Non-invasive Cardiac Output Measurements by the ClearSight Hemodynamic Monitoring System to Thermodilution Measurements in Pediatric Patients Undergoing Cardiac Catheterization.
Specific aim 1: The specific aim of this study is to compare cardiac output measurements as well as cardiac index, and stroke volume obtained via thermodilution during a cardiac catheterization with data obtained by the ClearSight cardiac output monitoring system. Specific aim 2: To compare arterial blood pressure measurements obtained by arterial line with arterial waveform measurements obtained by the ClearSight System. The hypothesis is: Cardiac output measurements or arterial blood pressure measurements taken non-invasively with the ClearSight system in pediatric patients who are either undergoing cardiac catheterization or have an arterial line will correlate with cardiac output measurements taken by pulmonary artery catheter thermodilution or arterial pressures measured by an arterial line.
Read the detailed description
Specific aim number one: To compare cardiac output measurements obtained from the Clear Sight cardiac output monitor with measurements obtained with thermodilution in the cardiac catheterization laboratory. Significance: Currently, based on the Surviving Sepsis guidelines, fluid administration is supposed to be guided by measurements of fluid responsiveness. Currently, there are very few ways to obtain measurements of fluid responsiveness, such as cardiac output, stroke volume, and systemic vascular resistance non-invasively. The invasive methods are no longer used in pediatrics, as the risk of placing these invasive catheters is felt to outweigh the benefit of using the data provided by the invasive cardiac output monitoring systems. Although the Clear Sight cardiac output monitoring system has been validated in adults to measure cardiac output non-invasively, this technology has not been evaluated in pediatrics. If the Clear Sight monitoring system is shown to be accurate in pediatrics, it would safely provide data that could be lifesaving to a pediatric patient in shock.
Specific aim number two: To compare the accuracy of the Clear Sight cardiac output monitor in obtaining continuous blood pressure measurements non-invasively. Significance: Currently, the only reliable method to continuously monitor blood pressure in critically ill patients is with an invasive intra-arterial catheter. Placing this catheter carries risks with it, including risk of infection as well as risk of intra-arterial thrombus which can lead to limb ischemia. The Clear Sight cardiac output monitor has the technology to obtain continuous blood pressure measurements non-invasively, although this technology has never been validated in pediatric patients. Therefore, specific aim 1 is to determine if this technology can reliably be used in pediatric patients. If it can, this would provide a method to obtain continuous blood pressure measurements without the risk of an invasive catheter.
Hypothesis: Cardiac output and arterial blood pressure measurements taken non-invasively with the ClearSight system in will correlate with cardiac output measurements taken by pulmonary artery catheter thermodilution and arterial blood pressure measurements taken by arterial line. This hypothesis is based on personal communications with the developers of this device.
- Conditions
- Shock, Hypotension and Shock
- Being tested
- Measurement by Clearsight device
- Medical subject headings
- Shock, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement by Clearsight deviceDevice
Clearsight Device is used to obtain non-invasive measurements to be correlated to standard invasive measurements.
| Study group | Role | What they receive |
|---|---|---|
| arterial line | Pediatric patients admitted to the ICU with a medically indicated arterial line. Receives: Device: Measurement by Clearsight device | |
| cardiac output | Pediatric patients requiring cardiac output measurement by thermodilution through cardiac catheterization. Receives: Device: Measurement by Clearsight device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of non-invasive cardiac output or continuous blood pressure correlated to invasive measurements.
Comparison of measurements obtained by the ClearSight device compared to the invasive measurements will be used to evaluate whether the ClearSight device has any validity in pediatrics.
Measured: 11/2/2017 - 6/1/2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start2 Nov 2017
- Primary completion1 Mar 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701646
- Sponsor's protocol ID
- 1146179
- Status last verified
- Jun 2023
- First submitted
- 8 Oct 2018
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Non-invasive Cardiac Output Measurements by the ClearSight Hemodynamic Monitoring System to Thermodilution Measurements in Pediatric Patients Undergoing Cardiac Catheterization.
- ClinicalTrials.gov ID
- NCT03701646
- Acronym / sponsor ID
- 1146179
- Conditions
- Shock, Hypotension and Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 10 Oct 2018 (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.
Specific aim 1: The specific aim of this study is to compare cardiac output measurements as well as cardiac index, and stroke volume obtained via thermodilution during a cardiac catheterization with data obtained by the ClearSight cardiac output monitoring system. Specific aim 2: To compare arterial blood pressure measurements obtained by arterial line with arterial waveform measurements obtained by the ClearSight System. The hypothesis is: Cardiac output measurements or arterial blood pressure measurements taken non-invasively with the ClearSight system in pediatric patients who are either undergoing cardiac catheterization or have an arterial line will correlate with cardiac output measurements taken by pulmonary artery catheter thermodilution or arterial pressures measured by an arterial line.
Detailed description
Specific aim number one: To compare cardiac output measurements obtained from the Clear Sight cardiac output monitor with measurements obtained with thermodilution in the cardiac catheterization laboratory. Significance: Currently, based on the Surviving Sepsis guidelines, fluid administration is supposed to be guided by measurements of fluid responsiveness. Currently, there are very few ways to obtain measurements of fluid responsiveness, such as cardiac output, stroke volume, and systemic vascular resistance non-invasively. The invasive methods are no longer used in pediatrics, as the risk of placing these invasive catheters is felt to outweigh the benefit of using the data provided by the invasive cardiac output monitoring systems. Although the Clear Sight cardiac output monitoring system has been validated in adults to measure cardiac output non-invasively, this technology has not been evaluated in pediatrics. If the Clear Sight monitoring system is shown to be accurate in pediatrics, it would safely provide data that could be lifesaving to a pediatric patient in shock.
Specific aim number two: To compare the accuracy of the Clear Sight cardiac output monitor in obtaining continuous blood pressure measurements non-invasively. Significance: Currently, the only reliable method to continuously monitor blood pressure in critically ill patients is with an invasive intra-arterial catheter. Placing this catheter carries risks with it, including risk of infection as well as risk of intra-arterial thrombus which can lead to limb ischemia. The Clear Sight cardiac output monitor has the technology to obtain continuous blood pressure measurements non-invasively, although this technology has never been validated in pediatric patients. Therefore, specific aim 1 is to determine if this technology can reliably be used in pediatric patients. If it can, this would provide a method to obtain continuous blood pressure measurements without the risk of an invasive catheter.
Hypothesis: Cardiac output and arterial blood pressure measurements taken non-invasively with the ClearSight system in will correlate with cardiac output measurements taken by pulmonary artery catheter thermodilution and arterial blood pressure measurements taken by arterial line. This hypothesis is based on personal communications with the developers of this device.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arterial line | – | Device: Measurement by Clearsight devicePediatric patients admitted to the ICU with a medically indicated arterial line. |
| cardiac output | – | Device: Measurement by Clearsight devicePediatric patients requiring cardiac output measurement by thermodilution through cardiac catheterization. |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients admitted to the ICU requiring an arterial line, or patients undergoing cardiac output measurements by cardiac catheterization by thermodilution.
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 |
|---|---|---|
| Measurement by Clearsight deviceClearsight Device is used to obtain non-invasive measurements to be correlated to standard invasive measurements. | Device | arterial line, cardiac output |
Primary outcome
Measurement of non-invasive cardiac output or continuous blood pressure correlated to invasive measurements.
Time frame: 11/2/2017 - 6/1/2019
Comparison of measurements obtained by the ClearSight device compared to the invasive measurements will be used to evaluate whether the ClearSight device has any validity in pediatrics.
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 Jun 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Shock and Hypotension and Shock, run by Nemours Children's Clinic 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?
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 Jun 2023. 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?
Measurement of non-invasive cardiac output or continuous blood pressure correlated to invasive measurements. (time frame: 11/2/2017 - 6/1/2019). 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 Jun 2023.