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

June 13, 2023 updated by: Hopital Foch

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Elisabeth Huilier-Ammar, Dr

Study Contact Backup

  • Name: Alexis Paternot, Dr

Study Locations

  • France
      • Paris, France, 75014
        • Groupe Hospitalier Paris Saint-Joseph
      • Suresnes, France, 92150
        • Hôpital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with a hemodynamic abnormality using the data obtained using the Biobeat patch.
Time Frame: 72 hours
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.
Time Frame: 72 hours

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.
Time Frame: 72 hours

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.
Time Frame: 72 hours

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.
Time Frame: 72 hours

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.
Time Frame: 72 hours

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
Time Frame: 72 hours

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
Time Frame: 72 hours
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
Time Frame: 72 hours
4- point Likert scale (from 0 = intolerable to 4 = no problem at all)
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

  • Principal Investigator: Alexis Paternot, Dr, Hôpital Foch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2020

Primary Completion (Actual)

December 16, 2022

Study Completion (Actual)

December 16, 2022

Study Registration Dates

First Submitted

October 5, 2020

First Submitted That Met QC Criteria

October 12, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020_0050

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Dryad Repository

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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