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

Primary Purpose

Hypovolemia

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Probefix
Sponsored by
Rijnstate Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypovolemia focused on measuring ultrasound, cardiac output, Probefix, passive leg raising test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rijnstate Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cardiac output measurements

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Patients in which the ProbeFixR can be used
Percentages will be reported.

Full Information

First Posted
September 18, 2017
Last Updated
September 24, 2019
Sponsor
Rijnstate Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03497754
Brief Title
The Use of an External Ultrasound Fixator (ProbeFixR) on Intensive Care Patients
Acronym
Soundprobe
Official Title
The Use of an External Ultrasound Fixator (ProbeFixR) on Intensive Care Patients, a Feasibility Study. (the Soundprobe Study)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 17, 2018 (Actual)
Primary Completion Date
April 23, 2019 (Actual)
Study Completion Date
April 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rijnstate Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovolemia
Keywords
ultrasound, cardiac output, Probefix, passive leg raising test

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiac output measurements
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Probefix
Intervention Description
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.
Primary Outcome Measure Information:
Title
The correlation between the measurements done by FlotracR and TTE with and TTE without ProbeFixR
Description
A Bland and Altman plot will be constructed and the limits of agreement will be calculated.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
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)'
Description
Percentages will be reported.
Time Frame
8 weeks
Title
Is the Probefix unpleasant on a scale of 0-10
Description
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.
Time Frame
8 weeks
Title
Patients in which the ProbeFixR can be used
Description
Percentages will be reported.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bianca Baten, PhD
Organizational Affiliation
Rijnstate Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Rijnstate Hospital
City
Arnhem
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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