Clinical trial NCT03497754: The Use of an External Ultrasound Fixator (ProbeFixR) on Intensive Care Patients
Official title: The Use of an External Ultrasound Fixator (ProbeFixR) on Intensive Care Patients, a Feasibility Study. (the Soundprobe Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypovolemia
Keywords: ultrasound
cardiac output
Probefix
passive leg raising test
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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).

Eligibility criteria: 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

Primary outcomes:
measure: The correlation between the measurements done by FlotracR and TTE with and TTE without ProbeFixR
timeFrame: 8 weeks
Secondary outcomes:
measure: 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)'
timeFrame: 8 weeks
measure: Is the Probefix unpleasant on a scale of 0-10
timeFrame: 8 weeks
measure: Patients in which the ProbeFixR can be used
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
Study officials:
affiliation: Rijnstate Hospital
name: Bianca Baten, PhD
role: STUDY_DIRECTOR
References: