Rijnstate Hospital
Arnhem, Netherlands
NCT Number: NCT03497754
Study to assess the feasibility of an external ultrasound fixator (ProbeFix)
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Arnhem, Netherlands
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 8 weeks
A Bland and Altman plot will be constructed and the limits of agreement will be calculated.
Time frame: 8 weeks
Percentages will be reported.
Time frame: 8 weeks
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
Percentages will be reported.
Rijnstate Hospital
Other
The Use of an External Ultrasound Fixator (ProbeFixR) on Intensive Care Patients, a Feasibility Study. (the Soundprobe Study)
Acronym: Soundprobe
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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