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Surgery--ComplicationsBiobeat-PostopNCT04585178

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

A study testing Biobeat patch in people with Surgery--Complications, run by Hopital Foch at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Surgery--Complications
What is being tested?
Biobeat patch
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
109 participants
Where
2 sitesFrance
Study dates
15 Dec 2020to 16 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Patient with a known allergy to metals, plastics and silicone
  • Patient deprived of liberty or under guardianship
  • Pregnancy or breastfeeding

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Groupe hospitalier Paris Saint-Joseph

    Paris, 75014

  • Hopital Foch

    Suresnes, 92150

Other trials in France

About this study

Official title: 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.

Being tested
Biobeat patch
Keywords
surgery, vital signs, continuous monitoring

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biobeat patchDevice

    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)

Study groups in NCT04585178
Study groupRoleWhat they receive
Biobeat patchExperimentalPatients will be asked to keep Biobeat patch during 72 hours after their surgery.
Receives: Device: Biobeat patch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 72 hours

Secondary outcomes (8)

  1. 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

    Measured: 72 hours

  2. 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%

    Measured: 72 hours

  3. 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%

    Measured: 72 hours

  4. 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

    Measured: 72 hours

  5. 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

    Measured: 72 hours

  6. 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).

    Measured: 72 hours

  7. 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).

    Measured: 72 hours

  8. Evaluation of patients' tolerance to wearing the Biobeat device

    4- point Likert scale (from 0 = intolerable to 4 = no problem at all)

    Measured: 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2020
  2. Study start15 Dec 2020
  3. Primary completion16 Dec 2022
  4. Study completion16 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Single group assignment
Masking
None (open label)
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04585178
Sponsor's protocol ID
2020_0050
Acronym
Biobeat-Postop
Status last verified
Jun 2024
First submitted
5 Oct 2020
Last updated
14 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Dryad Repository

Publications

  • 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.

    PubMed 32487822

  • 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.

    PubMed 15273542

  • 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.

    PubMed 30620066

  • 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.

    PubMed 30875354

  • 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.

    PubMed 42008422

  • 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.

    PubMed 34754421

Questions about this trial

What is this clinical trial studying?

A study testing Biobeat patch in people with Surgery--Complications, run by Hopital Foch at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with a hemodynamic abnormality using the data obtained using the Biobeat patch. (time frame: 72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04585178, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.

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