The Use of an External Ultrasound Fixator (ProbeFixR) on Intensive Care Patients

Study Overview
=================
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).

Official Title
-----------------
The Use of an External Ultrasound Fixator (ProbeFixR) on Intensive Care Patients, a Feasibility Study. (the Soundprobe Study)

Conditions
-----------------
Hypovolemia

Intervention / Treatment
-----------------
* Device: Probefix


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac output measurements<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ultrasound, cardiac output, Probefix, passive leg raising test