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

Surgery--Complications Clinical Trial

— Biobeat-Postop  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04585178
• Other study ID #: 2020_0050
• Status: Completed
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: December 16, 2022

Study information

• Verified date: June 2024
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: December 16, 2022
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery--Complications

Intervention

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)

Locations

Country	Name	City	State
France	Groupe hospitalier Paris Saint-Joseph	Paris
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	72 hours
Secondary	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	72 hours
Secondary	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%	72 hours
Secondary	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%	72 hours
Secondary	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	72 hours
Secondary	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	72 hours
Secondary	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).	72 hours
Secondary	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).	72 hours
Secondary	Evaluation of patients' tolerance to wearing the Biobeat device	4- point Likert scale (from 0 = intolerable to 4 = no problem at all)	72 hours