Clinical Trials Logo

Clinical Trial Summary

This study aims to develop a digitally assisted telemonitoring platform using the Samsung TM Galaxy Watch5 smartwatch, validating the applicability of the solution in patients with POAF (Postoperative Atrial Fibrillation), along with the accuracy of the smartwatch in detecting vital signs through optical sensors and possibly identifying irregularities in heart rhythm. The validation of its applicability will be carried out through a clinical trial. This is a randomized observational pilot study resulting from the partnership established in the base year of 2022 between InCor and Samsung. The sample consisted of 108 outpatient patients with cardiac diseases who underwent cardiac surgery and were selected during the preoperative consultation. Subsequently, the patients were randomized (1:1) into the intervention group (teleassisted group) or the control group (standard institution follow-up). The sample size was proposed by the contracting party as this is a pilot study to assess whether the implementation of a technological solution assists in monitoring and predicting the risk of surgical patients in the postoperative phase, as well as the accuracy of the Samsung TM Galaxy Watch5 smartwatch in a sample with POAF.


Clinical Trial Description

This interventional study was conducted exclusively at the Heart Institute of the Clinics Hospital of the Medical School of the University of São Paulo (InCor - HCFMUSP). It was a single-center study divided into six phases. The first phase involved outpatient preoperative care, where patients underwent a comprehensive anamnesis during the preoperative consultation and were informed about the study. In the second phase, patients were hospitalized and provided with the Informed Consent Form (ICF) if they met the inclusion criteria. Demographic data were collected during this phase. During the surgical phase (third phase), intraoperative data were collected after cardiac surgery. The fourth phase focused on postoperative care, where patients were evaluated, and health measures such as blood pressure (BP), heart rate (HR), electrocardiogram (ECG), and peripheral oxygen saturation (SpO2) were collected using the SAMSUNGTM Galaxy Watch5 smartwatch and reference devices. After discharge, the fifth phase involved a 30-day telemonitoring period, where patients were remotely monitored using the smartwatch. Health data, including BP, HR, ECG, and SpO2, were collected three times a day during this phase. The medical team provided clinical interventions when alerts were received via the "FAPO SI³" platform. In the final phase, patients returned for an outpatient visit at InCor, where health measures were collected again using the smartwatch and reference devices. Additionally, a World Health Organization Quality of Life (WHOQOL) questionnaire was administered to assess patients' quality of life. ECG reports issued by the smartwatch were also reviewed. The control group consisted of patients with heart disease who underwent surgical procedures and received standard outpatient and post-surgical follow-up according to institutional routines and protocols. Overall, the study aimed to develop and validate an assisted digital telemonitoring platform for patients with postoperative atrial fibrillation (POAF). The telemonitored group used the SAMSUNGTM Galaxy Watch5 smartwatch for remote monitoring, while the control group followed standard care protocols. ;


Study Design


Related Conditions & MeSH terms

  • Heart; Surgery, Heart, Functional Disturbance as Result

NCT number NCT05966857
Study type Interventional
Source University of Sao Paulo
Contact
Status Completed
Phase N/A
Start date February 17, 2023
Completion date May 23, 2023

See also
  Status Clinical Trial Phase
Withdrawn NCT03282292 - Central Venous Catheter Insertion Site and Colonization in Pediatric Cardiac Surgery N/A
Completed NCT05264766 - The Use of Cooling Helmet for Neuroprotection Management in Open Heart Surgery N/A
Completed NCT05032469 - Foot Reflexology to Reduce Pain and Anxiety Before Chest Tube Removal N/A
Completed NCT03309137 - Device for Bacteremia Prevention in Post Cardiac Surgical Intensive Care Unit Patients N/A
Recruiting NCT05740397 - Trial to Compare Different Strategies of Mean Arterial Pressure Management During Cardiopulmonary By-pass N/A
Completed NCT05824598 - Multifunctional Approach in Cardiac Surgery N/A
Recruiting NCT05178680 - Combination of Music and Relaxing Light on the Patient's Anxiety After Cardiac Surgery in the Intensive Care Unit N/A
Recruiting NCT03491163 - Evaluation of Damaging Factors to Endothelial Glycocalyx During Heart Surgery Pilot Study
Completed NCT05763238 - Exercise Training in Children With Corrective Cardiac Surgeries N/A
Completed NCT01926067 - Monitoring of Cardiac Function With 3-axis Accelerometers N/A
Recruiting NCT04094168 - Clinical Impact of Del Nido Cardioplegia in Adult Cardiac Surgery Phase 4
Completed NCT04562207 - Pre-operative Carriage of Respiratory VIRUSes, and Acute Respiratory Distress Syndrome After Heart Surgery N/A
Completed NCT04197570 - Opioid-free Anesthesia for Open Cardiac Surgery: A Prospective Randomized Controlled Trial Phase 3
Completed NCT05656937 - Oblique Versus Transverse Orientation Approach for Internal Jugular Venous Cannulation in Pediatrics N/A
Completed NCT01141556 - Effects of High-dose Intravenous Selenium (Selenase®) in Adult Patients Subjected to Elective All-cause Heart Surgery Phase 3
Completed NCT05902052 - Development of Open Heart Surgery Patient Care Protocol and Its Effect on Post-sternotomy Pain N/A
Completed NCT06085066 - The Role of Modified Ultrafiltration Following Open Heart Surgery N/A
Completed NCT06435715 - The Effect of 10 Repetitions of Deep Breathing Exercises N/A
Not yet recruiting NCT06286111 - Red Cell Distribution Width as a Predictor for Post Operative Atrial Fibrillation After Open Heart Surgries
Completed NCT03429335 - Just TRAC It! Transitioning Responsibly to Adult Care Using Smart Phone Technology N/A