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

Not Applicable

Completed

• Conditions: Hypovolemia
• Interventions: Device: Probefix

• Registration Number: NCT03497754
• Lead Sponsor: Rijnstate Hospital

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 Timeline

• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2018-04-12
• Study First Posted: 2018-04-13
• Study Start: 2018-05-17
• Primary Completion: 2019-04-23
• Study Completion: 2019-04-23
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiac output measurements	Probefix	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

Primary Outcome Measures

Name	Time	Method
The correlation between the measurements done by FlotracR and TTE with and TTE without ProbeFixR	8 weeks	A Bland and Altman plot will be constructed and the limits of agreement will be calculated.

Secondary Outcome Measures

Name	Time	Method
Patients in which the ProbeFixR can be used	8 weeks	Percentages will be reported.
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	Percentages will be reported.
Is the Probefix unpleasant on a scale of 0-10	8 weeks	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.

Trial Locations

Locations (1)

Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands