Image-based remote monitoring in cardiac surgery patients: FORSEE 3 trial

Recruiting

Conditions: Postoperatieve complicaties na hartchirurgie
deterioration after surgery
Postoperative complications

Registration Number: NL-OMON53349

Lead Sponsor: Catharina-ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

- Age >= 18 years
- Willing and able to sign informed consent form
- Patients admitted to the cardio-thoracic ward after cardiac surgery
- Planned stay on the cardio-thoracic ward at least 48 hours

Exclusion Criteria

- Pregnancy
- Inability to provide written informed consent
- Mental disability
- Language barrier
- Inability to wear Healthdot: known severe allergy for the tissue adhesive
used in the Healthdot, any skin condition or use of topicals at the area of
application of the Healthdot

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) Percentage of data loss due to<br /><br>- Time out of scope of patients<br /><br>- Privacy window closed<br /><br>- Artifacts<br /><br>2) insight in optimal data storage and processing solutions<br /><br>3) insight in user- and patient acceptance of the image-based monitoring<br /><br>technology</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Performance of image-based heart- and respiration rate measurements in<br /><br>comparison with the reference devices<br /><br>2) Performance of image-based circadian rhythm measurements in comparison with<br /><br>the reference devices<br /><br>3) The ability of the image-based data to detect clinical deterioration,<br /><br>expressed as sensitivity and specificity<br /><br>4) The predictive value of each image-based parameter in the prediction of<br /><br>deterioration<br /><br>5) Potential time gain in the detection of clinical deterioration<br /><br>6) Optimal positioning, hardware and settings of cameras to gain high quality<br /><br>data in a regular cardiothoracic wardroom<br /><br>7) Insight in correlation of clinical deterioration detected with the<br /><br>image-based monitoring technology and long-term patient outcomes. </p><br>