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Study to assess the feasibility of an external ultrasound fixator (ProbeFix)
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probefix | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Is the Probefix unpleasant on a scale of 0-10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bianca Baten, PhD | Rijnstate Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital | Arnhem | Netherlands |
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| ID | Term |
|---|---|
| D020896 | Hypovolemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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. |
| 8 weeks |
| Patients in which the ProbeFixR can be used | Percentages will be reported. | 8 weeks |