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

Hypovolemia Clinical Trial

— Soundprobe  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03497754
• Other study ID #: NL62664.091.17
• Status: Completed
• Phase: N/A
• Start date: May 17, 2018
• Est. completion date: April 23, 2019

Study information

• Verified date: September 2019
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study to assess the feasibility of an external ultrasound fixator (ProbeFix)

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 23, 2019
• Est. primary completion date: April 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypovolemia

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Patients in which the ProbeFixR can be used	Percentages will be reported.	8 weeks