Health TrialsbyHealthPanel

Usability of Pericardial Flushing with the Haermonics Pure System After Cardiac Surgery

ConditionsSurgical Blood LossSurgical Complication
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHaermonics BV

About this trial

The goal of this clinical trial is to evaluate the usability of the Haermonics Pure system in patients undergoing a cardiac surgery procedure with the use of cardiopulmonary bypass.

All measurements and interventions are standard of care, except pericardial flushing with the Haermonics Pure system.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (≥18yrs and weight ≥40kg) undergoing cardiothoracic surgery (CABG and/or valve surgery, elective aortic surgery, Bentall procedure, ascending aorto/aortic arch replacement) with the use of cardiopulmonary bypass

Patient has been informed of the nature of the clinical investigation and is willing and able to give written informed consent for investigation participation

Disqualifiers

Euroscore II > 20%

Emergent procedures

Complication during surgery which is life threatening and/or requires another surgical intervention

Minimal invasive cardiac surgery procedures (e.g. minithoracotomy and hemisternotomy)

Trial design

Design model

Single group

Treatments tested in this trial

  • Haermonics Pure system

    Device

    pericardial flushing with Haermonics Pure system

Treatment groups

65 Participants
are divided into 1 treatment group
Group A: study subjectsOther 1 intervention

Trial outcomes

Primary outcomes

1

Usability to evaluate user satisfaction and functionality of all use aspects of the Haermonics Pure system within 65 patients by using a user questionnaire.

For each user, questions will be asked about the common use of the Hearmonics Pure system using a 0-10 Numeric Rating Scale.

Time frame
for all users at the end of the study, after enrollment of 65 patients, after approximately 5 months after the start of the study.
2

Usability to evaluate user satisfaction and functionality of all use aspects of the Haermonics Pure system within 65 patients by using a user questionnaire.

For each user, questions will be asked about the use of the Hearmonics Pure system in comparison with standard practice, with option 1 Hearmonics Pure system being better, with option 2 no difference, with option 3 standard of care being better.

Time frame
for all users at the end of the study, after enrollment of 65 patients, after approximately 5 months after the start of the study.
3

Usability to evaluate user satisfaction and functionality of all use aspects of the Haermonics Pure system within 65 patients by using a user questionnaire.

For each user, questions will be asked about the common use of the Hearmonics Pure system using the System Usability Scale (SUS). It is comprised of 10 questions that should be answered on a 5-point Likert scale.

Time frame
for all users at the end of the study, after enrollment of 65 patients, after approximately 5 months after the start of the study.

Secondary outcomes

1

Safety: Rate of device-related events up to discharge

Descriptive statistics

Time frame
From enrollment up to discharge or up to 2 weeks after surgery, whichever came first
2

Usability to evaluate user satisfaction and functionality of all use aspects of the Haermonics Pure system within 65 patients by using a user questionnaire.

Used by different user groups in different hospital settings when using the different components of the Haermonics Pure system for the different functionalities. User satisfaction is measured with a user questionaire, containing questions with a scale from 1-4, with 1: very unsatisfied, 2: unsatified; 3 satisfied; 4 very satisfied.

Time frame
For each user at each step for each patient trough study completion, which is expected to be around 3 times a week during approximately 5 months.
3

Safety: Rate of SAEs up to discharge

Relationship with the device will be determined for all SAEs. All events of reoperations, pericardiocetesis and pleurcentesis are considered to be SAEs.

Time frame
From enrollment up to discharge or up to 2 weeks after surgery, whichever came first
4

Efficacy: Drain fluid output 8 hours after start treatment (with sternum closed).

Total amount of fluid output, comparing this with the historical control established in the previous FLUID trial.

Time frame
start treatment (flushing) up to 8 hours after start treatment (flushing).

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Haermonics BV

Lead sponsor

Avania

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: