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The Box 2.0: using smart technology for early diagnosis of complications after cardiovascular surgery

The Box 2.0: using smart technology for early diagnosis of complications after cardiovascular surgery - The Box 2.0

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48739
Enrollment
365
Registered
2018-11-22
Start date
2018-11-22
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

afib Atrial fibrillation

Interventions

Introduction of eHealth: home monitoring in combination with a Webcam consult instead of regular follow-up on the outpatient clinic.

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patient undergoes cardiovascular surgery Patient is able to communicate in Dutch or English Patient has been referred by a cardiologist from the Leiden University Medical Center, Cardiological Center Voorschoten, Alrijne Hospital or Haaglanden Medical Center

Exclusion criteria

Exclusion criteria: Patient is under the age of 18 years Patient is pregnant Patient is considered an incapacitated adult Patient is unwilling to sign the informed consent form Patient undergoes emergency thoracic surgery (INTERMACS 1 or 2) Patient has active endocarditis at the time of operation Patient is on mechanical circulatory support before operation Patient has a ventricular septal rupture Patient undergoes extracorporeal membrane oxygenation or ventricular assist device insertion

Design outcomes

Secondary

MeasureTime frame
- Time to atrial fibrillation - Diagnosis and time to cardiac decompensation - Diagnosis and time to sternal wound infection - Number of cardiology or thoracic surgery related, unplanned hospital visits - Quality of life: EQ-5D questionnaires - Score of patient satisfaction considering (e)Visits and The Box - Anxiety (CAQ), illness perceptions (BIPQ) and engagement (TWEETS) - Major Adverse Cardiac Events: cardiac death, myocardial infarction, cardiac tamponade, ischaemic stroke; or TIA, defined as a transient episode of neurological dysfunction lasting for less than 1h, caused by focal brain or retinal ischaemia without recent infarction on cerebral imaging.15 - Mortality rate - Re-admission rate to the cardiology or thoracic surgery ward - Blood pressure control, which is having a systolic blood pressure of

Primary

MeasureTime frame
The primary endpoint of the study will be the diagnosis of atrial fibrillation.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)