Central Venous PressureNCT03160742
Pilot Study of a Non-Invasive Central Venous Pressure Monitoring System in Children
An observational study of Central Venous Pressure, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The goal of this research study is to determine the feasibility and accuracy of Mespere Life Science non-invasive central venous pressure monitoring system (Mespere VENUS 2000CVP system) in children with congenital heart disease (CHD). Read more about this study
- Who is it for?
- Ages 12 months to 10 years
- Conditions the study is for
- Central Venous Pressure
- What is being tested?
- Mespere VENUS 200CVP system
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2018to 14 Sep 2018
- 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 12 months to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: 30 children ages 12 months to 10.9 years scheduled to undergo a cardiac surgery with central venous pressure catheter monitoring at Boston Children's Hospital.
Who may be able to join
- 12 months of age to 10.9 years of age
- Scheduled to undergo a cardiac surgery with central venous pressure catheter monitoring at Boston Children's Hospital
Who cannot join
- undergo a procedure that does not require a central venous pressure catheter as part of routine monitoring
- Have a known venous occlusion or any other reason the central venous pressure may be unreliable
- Allergy to medical grade adhesives or have any pre-existing skin irritation/eczema at the sensor site
- Emergently scheduled procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
The goal of this research study is to determine the feasibility and accuracy of Mespere Life Science non-invasive central venous pressure monitoring system (Mespere VENUS 2000CVP system) in children with congenital heart disease (CHD).
Read the detailed description
Central venous pressure (CVP), also known as right atrial pressure (RAp), is a reflection of the right heart filling pressure i.e the preload of the right ventricle. Assessment of the CVP is essential in the management of different clinical situations in children. Invasive CVP monitoring by placement of a CVP catheter either in the internal jugular vein or the subclavian vein is the gold standard way of measuring the CVP both in children and adults. However, placing a CVP catheter in a child can be challenging, time consuming, often requires the child to be sedated and it is not without complications.
Being able to reliably measure the CVP noninvasively would be of great benefit for sick children as it may allow diagnoses to be made quickly and help guide treatment.
The goal of this proposal is to determine the feasibility and accuracy of Mespere Life Science non-invasive central venous pressure monitoring system (Mespere VENUS 2000CVP system) in children with congenital heart disease (CHD).
- Conditions
- Central Venous Pressure
- Being tested
- Mespere VENUS 200CVP system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mespere VENUS 200CVP systemDevice
Non-invasive sensor placed on the neck
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive monitoring | In addition to standard monitoring, the Mespere VENUS 200CVP system will be used to record central venous pressures. Receives: Device: Mespere VENUS 200CVP system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Mespere VENUS 2000CVP
The correlation between the non-invasive measurements from the Mespere VENUS 2000CVP system and the invasive central venous pressure measurements that are continuously collected as standard of care.
Measured: The data will be collected for the length of the cardiac surgery, up to 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start25 Apr 2018
- Primary completion25 Apr 2018
- Study completion14 Sep 2018
Why it stopped: Study device is incorrect size for pediatric patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous PressureStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mespere Lifesciences Inc.
- Responsible party
- Principal investigator, Kirsten Odegard, Boston Children's Hospital
- Investigators
- Kirsten Odegard, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160742
- Sponsor's protocol ID
- IRB-P00024295
- Status last verified
- Oct 2018
- First submitted
- 18 May 2017
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Non-Invasive Central Venous Pressure Monitoring System in Children
- ClinicalTrials.gov ID
- NCT03160742
- Acronym / sponsor ID
- IRB-P00024295
- Conditions
- Central Venous Pressure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study device is incorrect size for pediatric patients
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Mespere Lifesciences Inc.
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 25 Apr 2018 (actual)
- Study completion
- 14 Sep 2018 (actual)
- First posted
- 19 May 2017 (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.
The goal of this research study is to determine the feasibility and accuracy of Mespere Life Science non-invasive central venous pressure monitoring system (Mespere VENUS 2000CVP system) in children with congenital heart disease (CHD).
Detailed description
Central venous pressure (CVP), also known as right atrial pressure (RAp), is a reflection of the right heart filling pressure i.e the preload of the right ventricle. Assessment of the CVP is essential in the management of different clinical situations in children. Invasive CVP monitoring by placement of a CVP catheter either in the internal jugular vein or the subclavian vein is the gold standard way of measuring the CVP both in children and adults. However, placing a CVP catheter in a child can be challenging, time consuming, often requires the child to be sedated and it is not without complications.
Being able to reliably measure the CVP noninvasively would be of great benefit for sick children as it may allow diagnoses to be made quickly and help guide treatment.
The goal of this proposal is to determine the feasibility and accuracy of Mespere Life Science non-invasive central venous pressure monitoring system (Mespere VENUS 2000CVP system) in children with congenital heart disease (CHD).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-invasive monitoring | – | Device: Mespere VENUS 200CVP systemIn addition to standard monitoring, the Mespere VENUS 200CVP system will be used to record central venous pressures. |
Who may qualify
- Ages
- 12 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 30 children ages 12 months to 10.9 years scheduled to undergo a cardiac surgery with central venous pressure catheter monitoring at Boston Children's Hospital.
Key inclusion criteria (2 listed)
- 12 months of age to 10.9 years of age
- Scheduled to undergo a cardiac surgery with central venous pressure catheter monitoring at Boston Children's Hospital
Key exclusion criteria (4 listed)
- undergo a procedure that does not require a central venous pressure catheter as part of routine monitoring
- Have a known venous occlusion or any other reason the central venous pressure may be unreliable
- Allergy to medical grade adhesives or have any pre-existing skin irritation/eczema at the sensor site
- Emergently scheduled procedures
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 |
|---|---|---|
| Mespere VENUS 200CVP systemNon-invasive sensor placed on the neck | Device | Non-invasive monitoring |
Primary outcome
Accuracy of Mespere VENUS 2000CVP
Time frame: The data will be collected for the length of the cardiac surgery, up to 6 hours.
The correlation between the non-invasive measurements from the Mespere VENUS 2000CVP system and the invasive central venous pressure measurements that are continuously collected as standard of care.
Results and safety
The study was stopped early (reason given: Study device is incorrect size for pediatric patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- 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.
Kirsten Odegard, MD principal investigator
Boston Children's Hospital
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 Central Venous Pressure, run by Boston Children's Hospital 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 4 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: stopped early, as of the sponsor's last update on 9 Oct 2018. 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 was stopped early (reason given: Study device is incorrect size for pediatric patients). Results are not available in the source record.
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?
Accuracy of Mespere VENUS 2000CVP (time frame: The data will be collected for the length of the cardiac surgery, up to 6 hours.). 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 9 Oct 2018.