NCT03497754

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Rijnstate Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hypovolemia

Interventions

Type	Name	Description
DEVICE	Probefix	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.

Timeline

• Start date: 2018-05-17
• Primary completion: 2019-04-23
• Completion: 2019-04-23
• First posted: 2018-04-13
• Last updated: 2019-09-25

Locations

1 site across 1 country: Netherlands