Postoperative Atrial Fibrillation, Thoracic Surgery, Smartwatches, Rhythm Monitoring, Cardiovascular Prognosis, Asymptomatic Atrial Fibrillation, Randomized Trial
Conditions
Keywords
Postoperative atrial fibrillation, thoracic surgery, smartwatches, rhythm monitoring, cardiovascular prognosis, asymptomatic atrial fibrillation, randomized trial
Brief summary
Postoperative atrial fibrillation (POAF) occurs in approximately 20% of patients following thoracic surgery. Early diagnosis is essential to prevent complications such as heart failure, stroke, myocardial infarction, and increased mortality. Smartwatches equipped with single-lead ECG capabilities and algorithms to detect asymptomatic atrial fibrillation (AF) offer a potential solution. This study aims to evaluate the effectiveness of smartwatches in detecting POAF compared to standard care.
Interventions
OTHERsmartwatch
Patients in the smartwatch group will undergo rhythm monitoring with a smartwatch
OTHERECG
Detected POAF episodes will be confirmed via a 12-lead ECG
Sponsors
Clinique Victor Pauchet
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (\>18 years old). * Patients undergoing major thoracic surgery with one-lung ventilation within the past 48 hours. * Scheduled pneumonectomy or lobectomy. * Admission to a conventional surgical unit postoperatively. * Ability to perform single-lead ECG using a smartwatch. * Coverage under a social security system. * Signed informed consent
Exclusion criteria
* History of atrial fibrillation. * Requirement for telemetry for AV block or tachyarrhythmias (\>140 bpm). * Dependency on a pacemaker. * Participation in another interventional clinical trial affecting POAF incidence. * Mediastinal, pleural, or chest wall surgery. * Reoperations or surgeries performed more than 48 hours prior. * Pregnant women. * Patients under guardians or similar legal protection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the incidence of POAF | at day 7 | the incidence of POAF within seven days after scheduled thoracic surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of asymptomatic POAF | at day 7 | Rate of asymptomatic POAF, evaluated using the EHRA symptom score |
| Cardiovascular prognosis | at day 3 | Cardiovascular prognosis assessed through a composite outcome (MACE) |
| Feasibility of rhythm monitoring with a smartwatch | at day 7 | Feasibility of rhythm monitoring with a smartwatch, measured by device usage time and the proportion of successful single-lead ECGs performed. |
| Recurrence of AF | at 3 months | Recurrence of AF |
| management of AF | at 3 months | management of AF |
Countries
France
Contacts
Primary ContactPierre Huette, MD
Outcome results
None listed