TELEsurveillance of Patients in PostopErative Bridge surgeryAge CoronairE (TELE-PEACE)

TELEsurveillance of Patients in PostopErative Bridge surgeryAge CoronairE, Pilot Study

More than 20,000 patients benefit from coronary bypass surgery in France each year. Median discharge without complication is eight days postoperatively, whereas by day four after surgery, hospitalization is only necessary for medical supervision of the occurrence of complications (scar infection, atrial fibrillation, pericardial effusion), waiting for a downstream bed in cardiac rehabilitation.

Some studies have shown the feasibility of a return home from day 4 after CABG in the United States and England under some conditions of selection and monitoring of patients.

However, there is currently no validated telemonitoring tool for patients in early postoperative coronary bypass surgery.

In this pilot study, during hospitalization for early postoperative coronary bypass surgery, a combination of connected devices for the measurement of physiological parameters and for clinical self-evaluation by the patient will be evaluated. The results of this project will be used as a basis for a future larger study in which an early home discharge can be proposed to patients.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Bypass
• Intervention / Treatment: Device: connected objects

Detailed Description

More than 20,000 patients benefit from coronary bypass surgery in France every year. In the case of simple follow-up, the median discharge is eight days postoperatively, whereas by day 4 after surgery, hospitalization is only necessary for medical supervision of the occurrence of complications (scar infection, atrial fibrillation, pericardial effusion), waiting for a downstream bed in cardiac rehabilitation.

Some studies have shown the feasibility of a return home from day 4 after CABG in the United States and England under some conditions of selection and monitoring of patients.

However, there is currently no validated telemonitoring tool for patients in early postoperative coronary bypass surgery.

This is a prospective pilot study, monocentric, open. The intervention consists of the use of connected devices for the monitoring of physiological parameters and functional signs.The use of the connected objects by the patient will take place during hospitalization, in parallel of a standard medical and paramedical follow-up (usual care), from day 4 after coronary bypass a to discharge (or until day 12 maximum, ie 8 days of follow-up).

A combination of connected objects for the measurement of physiological parameters and for clinical self-evaluation by the patient, during early postoperative coronary bypass surgery will be evaluated.

The results of this project will be used as a basis for a future larger study in which an early home discharge can be proposed to patients.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Cimadevilla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients 18 years of age or older at baseline
2. Patient for whom isolated coronary bypass was performed
3. From the 4th day after the operation, epicardial electrodes removed since at least the day before inclusion day, normal blood pressure and heart rate, O2 saturation greater than 94% in ambient air, apyrexia, clean scar, not sign of congestive heart failure
4. From the 4th day after surgery, ECG of the day in sinus rhythm
5. From the 4th day after surgery, hemoglobin> 8g / dl, creatinine clearance> 30ml / min, during a blood sample of less than 24 hours
6. From the 4th day after the operation, no significant abnormalities during a chest X-ray less than 24 hours
7. From the 4th day after surgery, FEVG> 30%, dry pericardium or pericardial effusion ≤ 1cm without compression during transthoracic echocardiography less than 24 hours

Exclusion Criteria:

• Patients at high risk of complications:

  • Insulinorequising diabetics,
  • Non-autonomous,
  • With a context unfavorable to the implementation of the intervention: patient speaking little or no French, patient without social coverage, patient unable to manage complex actions on connected tools.
• Refusal to sign the consent. Protected persons (tutorship, safeguard of justice)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patient; interventional group	Device: connected objects; a combination of connected devices for measuring physiological parameters and for clinical self-assessment by the patient, for early postoperative coronary bypass surgeries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure measured by connected armband	The Evolution of blood pressure will be measured daily by connected armband, from day 4 postoperatively to discharge from hospital.	day 12 postoperatively or discharge from hospital
Temperature measured by connected thermometer	The Evolution of Temperature will be measured daily by connected thermometer, from day 4 postoperatively to discharge from hospital.	day 12 postoperatively or discharge from hospital
Heartbeat measured by connected electrocardiogram	The heartbeat will be measured daily by connected electrocardiogram, from day 4 postoperatively to discharge from hospital.	day 12 postoperatively or discharge from hospital
scar appearance	The Evolution of scar appearance will be measured daily by photography, from day 4 postoperatively to discharge from hospital.	day 12 postoperatively or discharge from hospital
pain measured	The Evolution of pain will be measured daily by an electronic analog visual pain scale, from day 4 postoperatively to discharge from hospital.	day 12 postoperatively or discharge from hospital

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Connected armband measurements	Concordance between connected armband blood pressure measurements, and reference measurements performed by the health care team during hospitalization.	day 12 postoperatively or discharge from hospital
Connected thermometer measurements.	Concordance between Temperature measured by connected thermometer and reference measurements performed by the health care team during hospitalization disorders, the investigators will evaluate (i) the concordance between the automatic interpretation of the connected ECG and the reading of the classical ECG on the one hand, (ii) the concordance between the automatic interpretation of the ECG connected and re-reading of this same route by a cardiologist.	day 12 postoperatively or discharge from hospital
Connected electrocardiogram	Concordance between connected electrocardiogram heart rate and reference measurements performed by the health care team during hospitalization. Concerning rhythm disorders, the investigators will evaluate (i) the concordance between the automatic interpretation of the connected ECG and the reading of the classical ECG on the one hand, (ii) the concordance between the automatic interpretation of the ECG connected and re-reading of this same route by a cardiologist.	day 12 postoperatively or discharge from hospital
photography of scar	Concordance between photography of scar appearance (flow, inflammation), and reference measurements performed by the health care team during hospitalization.	day 12 postoperatively or discharge from hospital
analog visual pain scale	Concordance between connected an electronic analog visual pain scale and reference measurements performed by the health care team during hospitalization.	day 12 postoperatively or discharge from hospital
Technical failures of connected objects.	Incidence of occurrence of technical failures of connected objects.	day 12 postoperatively or discharge from hospital
alert algorithms for the diagnosis of postoperative complications	Sensitivity and specificity of alert algorithms for the diagnosis of postoperative complications (pericardial effusion, heart failure, infection, atrial fibrillation).	day 12 postoperatively or discharge from hospital
Time between surgery and when the patient meets inclusion criteria	Time between surgery and when the patient meets the clinical, ECG, biological, radiographic and echocardiographic inclusion criteria	day 8 postoperatively
self-measurements performed by the patient	Proportion of self-measurements performed by the patient using the connected objects among all self-measurements requested.	day 12 postoperatively or discharge from hospital
items completed by the patient in the application	Proportion of items completed by the patient in the application among the total of items to be completed.	day 12 postoperatively or discharge from hospital
Patient satisfaction	Patient satisfaction measure	1 month
Caregiver satisfaction	Caregiver satisfaction measure	day 12 postoperatively or discharge from hospital
post-operative complications after discharge from hospital	Incidence of occurrence of post-operative complications after discharge from hospital (phone contact on D30).	1 month

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: GFI
• Investigators: Principal Investigator: Claire Cimadevilla, APHP

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2020
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 10, 2020
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (Actual): January 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: connected objects
• Other Study ID Numbers: APHP180485

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No