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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-15

Study Completion Date

2022-12-16

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.

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Detailed Description

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Conditions

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Surgery--Complications

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group assignment

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Biobeat patch

Patients will be asked to keep Biobeat patch during 72 hours after their surgery.

Group Type EXPERIMENTAL

Biobeat patch

Intervention Type 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)

Interventions

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Biobeat patch

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)

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No