Screening for Postoperative Vital Signs Abnormalities, and Particularly Hemodynamic Ones, by Continuous Monitoring Using the Biobeat Patch

Study Overview
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Brief Summary
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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.

Official Title
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Detection of Postoperative Complications and Particularly Hemodynamic Ones Through Continuous Monitoring Using the Biobeat Patch

Conditions
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Surgery--Complications

Intervention / Treatment
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* Device: Biobeat patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient 18 years of age or older Patient undergoing major digestive, gynecological, orthopedic or urological surgery (expected duration of surgery greater than 2 hours). Predictable postoperative hospitalization duration ≥ 2 nights Patient with a Health Insurance plan Not having opposed participation in the research Exclusion Criteria: Patient with significant deformity, swelling, irritation or with localized infection, ulceration or skin lesions on the torso Patient with a subcutaneous electronic pacemaker implant. Patient with a CT or MRI scan already scheduled for the first three days postoperatively Patient suffering from tremors or convulsions Patient with a torso tattoo Patient with significant chest hairiness Patient with a known allergy to metals, plastics and silicone Patient deprived of liberty or under guardianship Pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Single group assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biobeat patch<br>Patients will be asked to keep Biobeat patch during 72 hours after their surgery. | Device: Biobeat patch<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with hypotension detected by the routine nursing follow-up. | A hemodynamic abnormality is defined as: An MBP < 70 mmHg or an MBP < 65 mmHg or an MBP < 80% of the value measured during the preanesthetic consultation or an MBP < 70% of the value measured during the preanesthetic consultation or an MBP < 80% of the value measured in the OR before the induction of anesthesia or an MBP < 70% of the MBP measured in the OR before the induction of anesthesia or an MBP > 100 mmHg or an MBP > 110 mmHg or an MBP > 120 mmHg or an MBP > 130 mmHg or an MBP > 120% of the MBP measured during the preanesthetic consultation or an MBP > 130% of the MBP measured during the preanesthetic consultation or an MBP > 120% of the MBP measured in the OR before induction of anesthesia or an MBP > 130% of the MBP measured in the OR before induction of anesthesia or a heart rate < 40/min or a heart rate > 100/min or a rhythm disorder | 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: a breathing rate < 8/min or a breathing rate > 20/min or arterial oxygen saturation < 95% or arterial oxygen saturation ≤ 92% or arterial oxygen saturation ≤ 90% or arterial oxygen saturation ≤ 85% | 72 hours | 
| Proportion of patients with a postoperative respiratory abnormality detected by the routine nursing follow-up. | A postoperative respiratory abnormality is defined as: a breathing rate < 8/min or a breathing rate > 20/min or arterial oxygen saturation < 95% or arterial oxygen saturation ≤ 92% or arterial oxygen saturation ≤ 90% or arterial oxygen saturation ≤ 85% | 72 hours | 
| Proportion of patients with a temperature abnormality using the data obtained using the Biobeat patch. | A temperature abnormality is defined as: a temperature ≤ 36.8 °C or a temperature ≥ 38°C or a temperature ≥ 39°C | 72 hours | 
| Quantify and compare the frequency of temperature abnormality detected by the routine nursing follow-up. | temperature abnormality is defined as: a temperature ≤ 36.8 °C or a temperature ≥ 38°C or a temperature ≥ 39°C | 72 hours | 
| Concerning the Biobeat patch, frequency of artifacts or of absence of data | An artefact is defined as a value that is > 50% different from the previous value, unless it is followed by a value equal to ± 25%; or a value that is outside the physiologically plausible range (heart rate < 5 or > 250 bpm, systolic blood pressure < 20 mm Hg or > 300 mm Hg or lower than diastolic pressure plus 5 mm Hg, diastolic blood pressure < 5 mm Hg or > 225 mm Hg, change in SpO2 ≥ 8% between two consecutive measurements, breathing rate < 3 or > 125 breaths per minute, change in skin temperature ≥ 1° between two consecutive measurements). | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, vital signs, continuous monitoring