Lessons Learned from Telemonitoring in an Outpatient Bariatric Surgery Pathway-Secondary Outcomes of a Patient Preference Clinical Trial

Background: Remote monitoring is increasingly used to support postoperative care. This study aimed to describe the lessons learned from the use of telemonitoring in an outpatient bariatric surgery pathway. Materials and Methods: Patients were assigned based on their preference to an intervention cohort of same-day discharge after bariatric surgery. In total, 102 patients were monitored continuously for 7 days using a wearable monitoring device with a Continuous and Remote Early Warning Score–based notification protocol (CREWS). Outcome measures included missing data, course of postoperative heart and respiration rate, false positive notification and specificity analysis, and vital sign assessment during teleconsultation. Results: In 14.7% of the patients, data for heart rate was missing for &gt; 8 h. A day-night-rhythm of heart rate and respiration rate reappeared on average on postoperative day 2 with heart rate amplitude increasing after day 3. CREWS notification had a specificity of 98%. Of the 17 notifications, 70% was false positive. Half of them occurred between day 4 and 7 and were accompanied with surrounding reassuring values. Comparable postoperative complaints were encountered between patients with normal and deviated data. Conclusion: Telemonitoring after outpatient bariatric surgery is feasible. It supports clinical decisions, however does not replace nurse or physician care. Although infrequent, the false notification rate was high. We suggested additional contact may not be necessary when notifications occur after restoration of circadian rhythm or when surrounding reassuring vital signs are present. CREWS supports ruling out serious complications, what may reduce in-hospital re-evaluations. Following these lessons learned, increased patients’ comfort and decreased clinical workload could be expected. Trial Registration: ClinicalTrials.gov. Identifier: NCT04754893. Graphical Abstract: [Figure not available: see fulltext.]</p

Reliability of heart rate and respiration rate measurements with a wireless accelerometer in postbariatric recovery

Recognition of early signs of deterioration in postoperative course could be improved by continuous monitoring of vital parameters. Wearable sensors could enable this by wireless transmission of vital signs. A novel accelerometer-based device, called Healthdot, has been designed to be worn on the skin to measure the two key vital parameters respiration rate (RespR) and heart rate (HeartR). The goal of this study is to assess the reliability of heart rate and respiration rate measured by the Healthdot in comparison to the gold standard, the bedside patient monitor, during the postoperative period in bariatric patients. Data were collected in a consecutive group of 30 patients who agreed to wear the device after their primary bariatric procedure. Directly after surgery, a Healthdot was attached on the patients' left lower rib. Vital signs measured by the accelerometer based Healthdot were compared to vital signs collected with the gold standard patient monitor for the period that the patient stayed at the post-anesthesia care unit. Over all patients, a total of 22 hours of vital signs obtained by the Healthdot were recorded simultaneously with the bedside patient monitor data. 87.5% of the data met the pre-defined bias of 5 beats per minute for HeartR and 92.3% of the data met the pre-defined bias of 5 respirations per minute for RespR. The Healthdot can be used to accurately derive heart rate and respiration rate in postbariatric patients. Wireless continuous monitoring of key vital signs has the potential to contribute to earlier recognition of complications in postoperative patients. Future studies should focus on the ability to detect patient deterioration in low-care environments and at home after discharge from the hospital

Postbariatric EArly discharge Controlled by Healthdot (PEACH) trial: study protocol for a preference-based randomized trial

Introduction: Performing bariatric surgery in a daycare setting has a potential reduction in hospital costs and increase in patients’ satisfaction. Although the feasibility and safety of such care pathway has already been proven, its implementation is hampered by concerns about timely detection of short-term complications. This study is designed to evaluate a combined outcome measurement in outpatient bariatric surgery supplemented by a novel wireless remote monitoring system versus current standard of care. Methods and analysis: A total of 200 patients with multidisciplinary team approval for primary bariatric surgery will be assigned based on their preference to one of two postoperative trajectories: (1) standard of in-hospital care with discharge on the first postoperative day or (2) same day discharge with ongoing telemonitoring up to 7 days after surgery. The device (Healthdot R Philips) transfers heart rate, respiration rate, activity, and body posture of the patient continuously by LoRaWan network to our hospital’s dashboard (Philips Guardian). The primary outcome is a composite outcome measure within 30 days postoperative based on mortality, mild and severe complications, readmission, and prolonged length-of-stay. Secondary outcomes include patients’ satisfaction and data handling dimensions. Trial registration: ClinicalTrials.govNCT04754893, Registered on 12 February 2021

Continuous remote monitoring in post-bariatric surgery patients: development of an early warning protocol

Achtergrond: Continue monitoring van vitale parameters na bariatrische chirurgie kan postoperatieve bloedingen of naadlekkage detecteren. Doelstellingen: Dit rapport beschrijft de ontwikkeling van een continue remote early warning score (CREWS). Dit is een op EWS gebaseerd meldingsprotocol voor detectie van verslechtering bij bariatrische patiënten. Omgeving: Catharina Ziekenhuis, Nederland. Methoden: Verschillende CREWS-protocollen werden ontwikkeld door verschillende thresholds te combineren die indicatief zijn voor tachycardie en tachypneu met behulp van literatuurinzichten en expertsessies. Deze protocollen werden retrospectief getest met continu gemeten vitale functies in een cohort van 185 patiënten die primaire bariatrische chirurgie ondergingen. Een draagbaar bewakingsapparaat op afstand (Healthdot, Philips) werd gebruikt in het ziekenhuis en thuis tot 14 dagen na de operatie. De opgenomen uitkomsten waren demografie, gebruik van bètablokkers en complicaties die her-interventie noodzakelijk maakten. Resultaten: Thresholds van 110 slagen per minuut (bpm) en 20 ademhalingen per minuut (rpm) voor respectievelijk hartslag en ademhalingsfrequentie detecteerden postoperatieve bloedingen en anastomoselekkage met een gevoeligheid van 75% (3/4 patiënten). Het protocol was stil (geen alarmen/dag) bij 69,5% van de patiënten en produceerde meer dan 1 alarm/dag bij 1,6% van de patiënten. De gemiddelde postoperatieve hartslag werd niet beïnvloed door het gebruik van bètablokkers. Conclusies: Een beschrijving van de stappen in de ontwikkeling van een EWS-protocol bij bariatrische patiënten op basis van continue monitoring van de vitale functies is nuttig. Het meest gevoelige en stille protocol meet de hartslag en ademhalingsfrequentie met drempels van 110 bpm en 20 rpm en leek haalbaar voor klinisch gebruik. Er leek geen klinisch relevant effect van bètablokkers te zijn. Dit CREWS-protocol kan een startpunt zijn voor toekomstige studies

The Accuracy of Wrist-Worn Photoplethysmogram-Measured Heart and Respiratory Rates in Abdominal Surgery Patients: Observational Prospective Clinical Validation Study

BACKGROUND: Postoperative deterioration is often preceded by abnormal vital parameters. Therefore, vital parameters of postoperative patients are routinely measured by nursing staff. Wrist-worn sensors could potentially provide an alternative tool for the measurement of vital parameters in low-acuity settings. These devices would allow more frequent or even continuous measurements of vital parameters without relying on time-consuming manual measurements, provided their accuracy in this clinical population is established. OBJECTIVE: This study aimed to assess the accuracy of heart rate (HR) and respiratory rate (RR) measures obtained via a wearable photoplethysmography (PPG) wristband in a cohort of postoperative patients. METHODS: The accuracy of the wrist-worn PPG sensor was assessed in 62 post-abdominal surgery patients (mean age 55, SD 15 years; median BMI 34, IQR 25-40 kg/m 2). The wearable obtained HR and RR measurements were compared to those of the reference monitor in the postanesthesia or intensive care unit. Bland-Altman and Clarke error grid analyses were performed to determine agreement and clinical accuracy. RESULTS: Data were collected for a median of 1.2 hours per patient. With a coverage of 94% for HR and 34% for RR, the device was able to provide accurate measurements for the large majority of the measurements as 98% and 93% of the measurements were within 5 bpm or 3 rpm of the reference signal. Additionally, 100% of the HR and 98% of the RR measurements were clinically acceptable on Clarke error grid analysis. CONCLUSIONS: The wrist-worn PPG device is able to provide measurements of HR and RR that can be seen as sufficiently accurate for clinical applications. Considering the coverage, the device was able to continuously monitor HR and report RR when measurements of sufficient quality were obtained. TRIAL REGISTRATION: ClinicalTrials.gov NCT03923127; https://www.clinicaltrials.gov/ct2/show/NCT03923127

Accuracy of vital parameters measured by a wearable patch following major abdominal cancer surgery

Introduction: Recent advances in wearable technology allow for the development of wirelessly connected sensors to continuously measure vital parameters in the general ward or even at home. The present study assesses the accuracy of a wearable patch (Healthdot) for continuous monitoring of heartrate (HR) and respiration rate (RR). Materials and methods: The Healthdot measures HR and RR by means of chest accelerometry. The study population consisted of patients following major abdominal oncological surgery. The analysis focused on the agreement between HR and RR measured by the Healthdot and the gold standard patient monitor in the intensive and post-anesthesia care unit. Results: For HR, a total of 112 h of measurements was collected in 26 patients. For RR, a total of 102 h of measurements was collected in 21 patients. On second to second analysis, 97% of the HR and 87% of the RR measurements were within 5 bpm and 3 rpm of the reference monitor. Assessment of 5-min averaged data resulted in 96% of the HR and 95% of the RR measurements within 5 bpm and 3 rpm of the reference monitor. A Clarke error grid analysis showed that 100% of the HR and 99.4% of the 5-min averaged data was clinically acceptable. Conclusion: The Healthdot accurately measured HR and RR in a cohort of patients recovering from major abdominal surgery, provided that good quality data was obtained. These results push the Healthdot forward as a clinically acceptable tool in low acuity settings for unobtrusive, automatic, wireless and continuous monitoring