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Completed

NCT Number: NCT03497754

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rijnstate Hospital

Arnhem, Netherlands

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probefix

Device

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 outcomes

  1. 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

  1. 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)'

    Time frame: 8 weeks

    Percentages will be reported.

  2. Is the Probefix unpleasant on a scale of 0-10

    Time frame: 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.

  3. Patients in which the ProbeFixR can be used

    Time frame: 8 weeks

    Percentages will be reported.

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Official study title

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

Acronym: Soundprobe

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 13, 2018
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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