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Completed

NCT Number: NCT04585178

Screening for Postoperative Vital Signs Abnormalities, and Particularly Hemodynamic Ones, by 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.

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Key information

Conditions

Surgery--Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe hospitalier Paris Saint-Joseph, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biobeat patch

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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%

  3. 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%

  4. 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

  5. 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

  6. 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).

  7. 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).

  8. 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)

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

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

Acronym: Biobeat-Postop

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 14, 2020
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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