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Brief Summary: Post-operative morbidity remains a reality as shown by the International Surgical Outcomes Study published in 2016 and 2019 and by several recent publications which focus mainly on hypotension and cardio-vascular complications. Other complications, such as respiratory depression, are less often studied. The hypothesis is that this connected patch could be used in surgical departments to detect a postoperative complication.
Biobeat Technologies Ltd has developed a sensor which continuously records the photoplethysmographic waveform and allows the calculation of several physiological parameters: heart rate (HR), oxygen saturation (SpO2), systolic blood pressure (SBP), diastolic blood pressure (DBP), stroke volume (SV), cardiac output (CO), cardiac index (CI), systemic vascular resistance (SVR), respiratory rate (RR), and temperature.
The objective of this study is the quantification of hemodynamic, respiratory and temperature abnormalities detected by routine monitoring (routine nursing follow-up) and continuous monitoring by the Biobeat patch during the first 72 postoperative hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biobeat patch | Experimental | Patients will be asked to keep Biobeat patch during 72 hours after their surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biobeat patch | Device | The Biobeat device (BB-613WP) is a class IIa medical device and is a non-invasive patch used for monitoring vital signs in clinical and non-clinical settings. The sensor continuously records the photoplethysmographic waveform that allows the calculation of several physiological parameters: heart rate (HR), SPO2, systolic blood pressure (SBP) and change in SBP, diastolic blood pressure (DBP) and change in DBP, stroke volume (SV), cardiac output (CO), cardiac index (CI), systemic vascular resistance (SVR), and respiration rate (RR). Translated with www.DeepL.com/Translator (free version) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with a hemodynamic abnormality using the data obtained using the Biobeat patch. | A hemodynamic abnormality is defined as an mean Blood Pressure (MBP) < 60 mmHg | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with hypotension detected by the routine nursing follow-up. | A hemodynamic abnormality is defined as:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexis Paternot, Dr | Hopital Foch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe hospitalier Paris Saint-Joseph | Paris | 75014 | France | |||
| Hopital Foch |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32487822 | Background | Liem VGB, Hoeks SE, Mol KHJM, Potters JW, Grune F, Stolker RJ, van Lier F. Postoperative Hypotension after Noncardiac Surgery and the Association with Myocardial Injury. Anesthesiology. 2020 Sep;133(3):510-522. doi: 10.1097/ALN.0000000000003368. | |
| 15273542 | Background | Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. |
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Dryad Repository
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Single group assignment
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|
| 72 hours |
| Proportion of patients with a postoperative respiratory abnormality using the data obtained using the Biobeat patch. | A postoperative respiratory abnormality is defined as:
| 72 hours |
| Proportion of patients with a postoperative respiratory abnormality detected by the routine nursing follow-up. | A postoperative respiratory abnormality is defined as:
| 72 hours |
| Proportion of patients with a temperature abnormality using the data obtained using the Biobeat patch. | A temperature abnormality is defined as:
| 72 hours |
| Quantify and compare the frequency of temperature abnormality detected by the routine nursing follow-up. | temperature abnormality is defined as:
| 72 hours |
| Concerning the Biobeat patch, frequency of artifacts or of absence of data | An artefact is defined as
| 72 hours |
| Collection of postoperative complications that occurred during the monitoring period | A postoperative complication will be classified according to the classification of Dindo and Clavien (Dindo, Demartines et al. 2004). | 72 hours |
| Evaluation of patients' tolerance to wearing the Biobeat device | 4- point Likert scale (from 0 = intolerable to 4 = no problem at all) | 72 hours |
| Suresnes |
| 92150 |
| France |
| 30620066 | Background | International Surgical Outcomes Study (ISOS) group. Prospective observational cohort study on grading the severity of postoperative complications in global surgery research. Br J Surg. 2019 Jan;106(2):e73-e80. doi: 10.1002/bjs.11025. |
| 30875354 | Background | Turan A, Chang C, Cohen B, Saasouh W, Essber H, Yang D, Ma C, Hovsepyan K, Khanna AK, Vitale J, Shah A, Ruetzler K, Maheshwari K, Sessler DI. Incidence, Severity, and Detection of Blood Pressure Perturbations after Abdominal Surgery: A Prospective Blinded Observational Study. Anesthesiology. 2019 Apr;130(4):550-559. doi: 10.1097/ALN.0000000000002626. |
| 42008422 | Derived | Kouidri I, Landais C, Solis A, Petit D, Blondeau-Martin A, Merlin K, Trillat B, Le Guen M, Fischler M. Continuous remote monitoring of postoperative vital signs with the Biobeat patch: A multicenter prospective observational study. PLoS One. 2026 Apr 20;21(4):e0344662. doi: 10.1371/journal.pone.0344662. eCollection 2026. |
| 34754421 | Derived | Paternot A, Aegerter P, Martin A, Ouattara J, Ma S, Adjavon S, Trillat B, Alfonsi P, Fischler M, Le Guen M. Screening for postoperative vital signs abnormalities, and particularly hemodynamic ones, by continuous monitoring: protocol for the Biobeat-Postop cohort study. F1000Res. 2021 Jul 21;10:622. doi: 10.12688/f1000research.54781.2. eCollection 2021. |