The Use of an External Ultrasound Fixator (ProbeFixR) on Intensive Care Patients, a Feasibility Study. (the Soundprobe Study)
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rijnstate Hospital
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- The correlation between the measurements done by FlotracR and TTE with and TTE without ProbeFixR
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
The correlation between the measurements done by FlotracR and TTE with and TTE without ProbeFixR
Time Frame: 8 weeks
A Bland and Altman plot will be constructed and the limits of agreement will be calculated.
Secondary Outcomes
- Patients in which the ProbeFixR can be used(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)'(8 weeks)
- Is the Probefix unpleasant on a scale of 0-10(8 weeks)