Clinical trial NCT04585178: Screening for Postoperative Vital Signs Abnormalities, and Particularly Hemodynamic Ones, by Continuous Monitoring Using the Biobeat Patch
Official title: Detection of Postoperative Complications and Particularly Hemodynamic Ones Through Continuous Monitoring Using the Biobeat Patch
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery--Complications
Keywords: surgery
vital signs
continuous monitoring
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group assignment
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with a hemodynamic abnormality using the data obtained using the Biobeat patch.
timeFrame: 72 hours
Secondary outcomes:
measure: Proportion of patients with hypotension detected by the routine nursing follow-up.
timeFrame: 72 hours
measure: Proportion of patients with a postoperative respiratory abnormality using the data obtained using the Biobeat patch.
timeFrame: 72 hours
measure: Proportion of patients with a postoperative respiratory abnormality detected by the routine nursing follow-up.
timeFrame: 72 hours
measure: Proportion of patients with a temperature abnormality using the data obtained using the Biobeat patch.
timeFrame: 72 hours
measure: Quantify and compare the frequency of temperature abnormality detected by the routine nursing follow-up.
timeFrame: 72 hours
measure: Concerning the Biobeat patch, frequency of artifacts or of absence of data
timeFrame: 72 hours
measure: Collection of postoperative complications that occurred during the monitoring period
timeFrame: 72 hours
measure: Evaluation of patients' tolerance to wearing the Biobeat device
timeFrame: 72 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe hospitalier Paris Saint-Joseph
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Alexis Paternot, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
citation: 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.