Measuring cardiac output using TTE with and without the use of ProbeFix in adult Intensive Care patients in which a PLR test is used as a fluid challenge. The possible changes in cardiac output measured with TTE are compared with the measurements…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Correlation between cardiac output measurements with and without ProbeFix
with Flotrac measurements
2. percentage of patients in which the ProbeFix can be used
Secondary outcome
1. Signs of side effects of ProbeFix
2. If possible patients will be asked to rate the (un)comfort of the ProbeFix
Background summary
Vital parameters like cardiac output are monitored in Intensive Care patients.
Most standard monitoring devices are (minimal) invasive and requires access to
an arterial vessel (eg Flotrac).
Trans thoracic echocardiography (TTE) can also be used to measure cardiac
output. Strong point of TTE is the fact that TTE is non-invasive. When TTE is
used to measure cardiac output, the uktrasound probe is put on the body
manually, therefore the position of the probe may vary during consecutive
measurements thereby influencing the results.
The ProbeFix is an external ultrasound fixator designed to be attached to the
body using soft straps. By using the ProbeFix it could be possible to measure
consecutive cardiac output measurements in a more reliable way because the
measurements are done at exact the same position.
ProbeFix could attribute to the possibility of measuring cardiac output in the
least invasive way.
Study objective
Measuring cardiac output using TTE with and without the use of ProbeFix in
adult Intensive Care patients in which a PLR test is used as a fluid challenge.
The possible changes in cardiac output measured with TTE are compared with the
measurements done with Flotrac (golden standard)
Study design
Prospective feasibility study
Study burden and risks
There is a minimum of risk for the patients in this study.
1. Adult patients in which the standard monitoring through Flotrac is used can
be included in this study (no extra intervention needed)
2. in this study a PLR test is done twice. A PLR test is done by tilting the
bed (see drawing in protocol). If patients are suspected of not being able to
endure a PLR test, they are excluded. A PLR test is an international and safe
method to provide a reversible volume bolus to the patient (in contrast to a
real fluid bolus delivered by infusion of fluids).
3. TTE is ultimately safe, since the 1960*s ultrasound is used without any
known negative effects on humans.
4. The ProbeFix will be attached to the patients with straps made of soft,
non-traumatic material. The points where the probeFix is attached to the skin
are made of soft non-traumatic material. The ProbeFix is CE certified and will
be attached to te patient not longer than 30 minutes.
Wagnerlaan 55
Arnhem 6815AD
NL
Wagnerlaan 55
Arnhem 6815AD
NL
Listed location countries
Age
Inclusion criteria
Adult Intensive Care patients ( > 18 years), with hypovolemia detected with Flotrac (SVV > 10%)
Exclusion criteria
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 (in the Netherlands children are admitted to a special pediatric intensive care, therefore only adult patients can be included)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62664.091.17 |