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

Not Applicable

Completed

• Conditions: Surgery--Complications
• Interventions: Device: Biobeat patch

• Registration Number: NCT04585178
• Lead Sponsor: Hopital Foch

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-10-12
• Study First Posted: 2020-10-14
• Study Start: 2020-12-15
• Primary Completion: 2022-12-16
• Study Completion: 2022-12-16
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Proportion of patients with a hemodynamic abnormality using the data obtained using the Biobeat patch.	72 hours	A hemodynamic abnormality is defined as an mean Blood Pressure (MBP) \< 60 mmHg

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with a postoperative respiratory abnormality using the data obtained using the Biobeat patch.	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%
Proportion of patients with hypotension detected by the routine nursing follow-up.	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
Proportion of patients with a temperature abnormality using the data obtained using the Biobeat patch.	72 hours	A temperature abnormality is defined as: * a temperature ≤ 36.8 °C; * or a temperature ≥ 38°C; * or a temperature ≥ 39°C
Collection of postoperative complications that occurred during the monitoring period	72 hours	A postoperative complication will be classified according to the classification of Dindo and Clavien (Dindo, Demartines et al. 2004).
Evaluation of patients' tolerance to wearing the Biobeat device	72 hours	4- point Likert scale (from 0 = intolerable to 4 = no problem at all)
Proportion of patients with a postoperative respiratory abnormality detected by the routine nursing follow-up.	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%
Quantify and compare the frequency of temperature abnormality detected by the routine nursing follow-up.	72 hours	temperature abnormality is defined as: * a temperature ≤ 36.8 °C; * or a temperature ≥ 38°C; * or a temperature ≥ 39°C
Concerning the Biobeat patch, frequency of artifacts or of absence of data	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).

Trial Locations

Locations (2)

Groupe hospitalier Paris Saint-Joseph; 🇫🇷 Paris, France

Hopital Foch; 🇫🇷 Suresnes, France