HypovolemiaSoundprobeNCT03497754
The Use of an External Ultrasound Fixator (ProbeFixR) on Intensive Care Patients
A study testing Probefix in people with Hypovolemia, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
Study to assess the feasibility of an external ultrasound fixator (ProbeFix) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypovolemia
- What is being tested?
- Probefix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 May 2018to 23 Apr 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Intensive Care patients ( > 18 years), with hypovolemia detected with Flotrac (SVV > 10%)
Who cannot join
- Pregnancy
- Atrial fibrillation or other irregular heart rhythm
- Pulmonary edema
- PLR not possible (eg neurological disease, spinal trauma, restricted limb movement, deep venous thrombosis, or any other reason as indicated by the attending intensivist).
- age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of an External Ultrasound Fixator (ProbeFixR) on Intensive Care Patients, a Feasibility Study. (the Soundprobe Study)
Study to assess the feasibility of an external ultrasound fixator (ProbeFix)
Read the detailed description
Rationale: Study to assess the feasibility of an external ultrasound fixator (ProbeFix) Objective: Cardiac output measurements using transthoracic ultrasound (TTE) with and without the use of the probeFixR will be evaluated in terms of accuracy. The TTE measurements will be combined with another form of cardiac output measurements (FlotracR) after a passive leg rasing (PLR) test.
Study design prospective, feasibility study Study population: Adult Intensive Care patients ( > 18 years)
Intervention (if applicable):
Consecutive adult patients on the ICU in which the FlotracR monitor is used will be evaluated after detection of hypovolemia.
Main study parameters/endpoints:
- Percentage of patients in which the ProbeFixR can be used
- The correlation between the measurements done by FlotracR and TTE with and TTE without ProbeFixR
Although no side effects are to be expected the investigators will monitor the patients after the ProbeFix is removed for any skin damage. The investigators will grade this damage into 3 categories:
- No skin marks
- Mild skin marks (no treatment necessary)
- Severe skin marks (surgical or medical treatment necessary)
- If the patients are awake the investigators will ask them whether they felt the ProbeFixR to be unpleasant on a scale of 0-10 (0 being: I did not feel anything and 10 being very unpleasant).
- Conditions
- Hypovolemia
- Being tested
- Probefix
- Keywords
- ultrasound, cardiac output, Probefix, passive leg raising test
- Medical subject headings
- Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbefixDevice
A passive leg raising test will be done twice to assess the fluid response. Changes in cardiac output are measured using TTE with and without the use of the Probefix.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac output measurements | Experimental | Cardiac output will be measured using TTE with and without the use of Probefix so not 2 arms but 2 consecutive measurements in the same patient Receives: Device: Probefix |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between the measurements done by FlotracR and TTE with and TTE without ProbeFixR
A Bland and Altman plot will be constructed and the limits of agreement will be calculated.
Measured: 8 weeks
Secondary outcomes (3)
Skin marks as possible side effect; scored as 'no skin marks', 'mild skin marks (no treatment necessary)' or 'severe skin marks (surgical or medical treatment necessary)'
Percentages will be reported.
Measured: 8 weeks
Is the Probefix unpleasant on a scale of 0-10
The VAS scale will be reported as mean with standard deviation if normally distributed or as median and inter-quartile range if not normally distributed.
Measured: 8 weeks
Patients in which the ProbeFixR can be used
Percentages will be reported.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start17 May 2018
- Primary completion23 Apr 2019
- Study completion23 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypovolemiaStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bianca Baten, PhD, Study director, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497754
- Sponsor's protocol ID
- NL62664.091.17
- Acronym
- Soundprobe
- Status last verified
- Sep 2019
- First submitted
- 18 Sep 2017
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of an External Ultrasound Fixator (ProbeFixR) on Intensive Care Patients, a Feasibility Study. (the Soundprobe Study)
- ClinicalTrials.gov ID
- NCT03497754
- Acronym / sponsor ID
- Soundprobe / NL62664.091.17
- Conditions
- Hypovolemia
- Keywords
- ultrasound, cardiac output, Probefix, passive leg raising test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 17 May 2018 (actual)
- Primary completion
- 23 Apr 2019 (actual)
- Study completion
- 23 Apr 2019 (actual)
- First posted
- 13 Apr 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.
Study to assess the feasibility of an external ultrasound fixator (ProbeFix)
Detailed description
Rationale: Study to assess the feasibility of an external ultrasound fixator (ProbeFix) Objective: Cardiac output measurements using transthoracic ultrasound (TTE) with and without the use of the probeFixR will be evaluated in terms of accuracy. The TTE measurements will be combined with another form of cardiac output measurements (FlotracR) after a passive leg rasing (PLR) test.
Study design prospective, feasibility study Study population: Adult Intensive Care patients ( > 18 years)
Intervention (if applicable):
Consecutive adult patients on the ICU in which the FlotracR monitor is used will be evaluated after detection of hypovolemia.
Main study parameters/endpoints:
- Percentage of patients in which the ProbeFixR can be used
- The correlation between the measurements done by FlotracR and TTE with and TTE without ProbeFixR
Although no side effects are to be expected the investigators will monitor the patients after the ProbeFix is removed for any skin damage. The investigators will grade this damage into 3 categories:
- No skin marks
- Mild skin marks (no treatment necessary)
- Severe skin marks (surgical or medical treatment necessary)
- If the patients are awake the investigators will ask them whether they felt the ProbeFixR to be unpleasant on a scale of 0-10 (0 being: I did not feel anything and 10 being very unpleasant).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac output measurements | Experimental | Device: ProbefixCardiac output will be measured using TTE with and without the use of Probefix so not 2 arms but 2 consecutive measurements in the same patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult Intensive Care patients ( > 18 years), with hypovolemia detected with Flotrac (SVV > 10%)
Key exclusion criteria (5 listed)
- Pregnancy
- Atrial fibrillation or other irregular heart rhythm
- Pulmonary edema
- PLR not possible (eg neurological disease, spinal trauma, restricted limb movement, deep venous thrombosis, or any other reason as indicated by the attending intensivist).
- age < 18 years
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 |
|---|---|---|
| ProbefixA passive leg raising test will be done twice to assess the fluid response. Changes in cardiac output are measured using TTE with and without the use of the Probefix. | Device | Cardiac output measurements |
Primary outcome
The correlation between the measurements done by FlotracR and TTE with and TTE without ProbeFixR
Time frame: 8 weeks
A Bland and Altman plot will be constructed and the limits of agreement will be calculated.
3 secondary outcomes
Skin marks as possible side effect; scored as 'no skin marks', 'mild skin marks (no treatment necessary)' or 'severe skin marks (surgical or medical treatment necessary)'
Time frame: 8 weeks
Is the Probefix unpleasant on a scale of 0-10
Time frame: 8 weeks
Patients in which the ProbeFixR can be used
Time frame: 8 weeks
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 25 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Hypovolemia
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Circulatory Failure, Critical Illness
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A Study to Assess the Safety and Efficacy of Centhaquine in Hypovolemic Shock Patients
Hypovolemic Shock
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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.
Bianca Baten, PhD study director
Rijnstate Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probefix in people with Hypovolemia, run by Rijnstate Hospital at 1 site in Netherlands.
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 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 25 Sep 2019. 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 Netherlands. 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 correlation between the measurements done by FlotracR and TTE with and TTE without ProbeFixR (time frame: 8 weeks). 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 25 Sep 2019.