An interventional study of Probefix in Hypovolemia, sponsored by Rijnstate Hospital. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-25.
Sponsored by Rijnstate Hospital · Not applicable, Interventional, and Diagnostic
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:
122 studies on the registry are indexed under Hypovolemia; 14 are open to participants now.
This study's enrollment of 10 is below the median of 40 across 61 interventional studies indexed under Hypovolemia.
Browse Hypovolemia studies →Rijnstate Hospital is the lead sponsor of 130 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
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
Device: Probefix
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.
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.
Time frame: 8 weeks
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.
Time frame: 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.
Time frame: 8 weeks
Patients in which the ProbeFixR can be used
Percentages will be reported.
Time frame: 8 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2018 to primary completion in Apr 2019, 11 months.
Of 19 interventional studies with no phase under Hypovolemia, half reached primary completion within 12 months of starting (the median); a quarter within 8 and three quarters within 20. This study's 11 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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