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

NCT04585178 | Completed

• 1 other identifier: 2020_0050
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 2

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.

Conditions

Surgery--Complications

Keywords

surgery; vital signs; continuous monitoring

Outcome Measures

Primary Outcomes (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

  72 hours

Secondary Outcomes (8)

• Proportion of patients with hypotension detected by the routine nursing follow-up.

  72 hours

• Proportion of patients with a postoperative respiratory abnormality using the data obtained using the Biobeat patch.

  72 hours

• Proportion of patients with a postoperative respiratory abnormality detected by the routine nursing follow-up.

  72 hours

• Proportion of patients with a temperature abnormality using the data obtained using the Biobeat patch.

  72 hours

• Quantify and compare the frequency of temperature abnormality detected by the routine nursing follow-up.

  72 hours

Study Arms (1)

Biobeat patch

EXPERIMENTAL

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

Device: Biobeat patch

Interventions

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)

Biobeat patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (2)

Groupe hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Hopital Foch

Suresnes, 92150, France

Location

Related Publications (5)

• 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.

  PMID: 32487822 BACKGROUND

• 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.

  PMID: 15273542 BACKGROUND

• 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.

  PMID: 30620066 BACKGROUND

• 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.

  PMID: 30875354 BACKGROUND

• 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.

  PMID: 34754421 DERIVED

Study Officials

• Alexis Paternot, Dr

  Hopital Foch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group assignment

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 14, 2020
• Study Start: December 15, 2020
• Primary Completion: December 16, 2022
• Study Completion: December 16, 2022
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

FR (2)