NCT03497754

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 13, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

May 17, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

11 months

First QC Date

September 18, 2017

Last Update Submit

September 24, 2019

Conditions

Hypovolemia

Keywords

ultrasoundcardiac outputProbefixpassive leg raising test

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

  • Is the Probefix unpleasant on a scale of 0-10

    8 weeks

  • Patients in which the ProbeFixR can be used

    8 weeks

Study Arms (1)

Cardiac output measurements

EXPERIMENTAL

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

Device: Probefix

Interventions

ProbefixDEVICE

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.

Cardiac output measurements

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult Intensive Care patients ( \> 18 years), with hypovolemia detected with Flotrac (SVV \> 10%)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rijnstate Hospital

Arnhem, Netherlands

Location

MeSH Terms

Conditions

Hypovolemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bianca Baten, PhD

    Rijnstate Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2017

First Posted

April 13, 2018

Study Start

May 17, 2018

Primary Completion

April 23, 2019

Study Completion

April 23, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)