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

H

Hopital Foch

Status

Completed

Conditions

Surgery--Complications

Treatments

Device: Biobeat patch

Study type

Interventional

Funder types

Other

Identifiers

NCT04585178
2020_0050

Details and patient eligibility

About

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.

Enrollment

109 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

109 participants in 1 patient group

Biobeat patch
Experimental group
Description:
Patients will be asked to keep Biobeat patch during 72 hours after their surgery.
Treatment:
Device: Biobeat patch

Trial contacts and locations

0

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Central trial contact

Alexis Paternot, Dr; Elisabeth Huilier-Ammar, Dr

Data sourced from clinicaltrials.gov

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