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

June 13, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
109

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hopital Foch

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alexis Paternot, Dr, Hopital 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 16, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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