TELEsurveillance of Patients in PostopErative Bridge surgeryAge CoronairE

Coronary Artery Bypass Clinical Trial

— TELE-PEACE  

Official title:

TELEsurveillance of Patients in PostopErative Bridge surgeryAge CoronairE, Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04236271
• Other study ID #: APHP180485
• Status: Completed
• Phase: N/A
• Start date: March 13, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Bypass

Intervention

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.

Locations

Country	Name	City	State
France	Cimadevilla	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	GFI

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Technical failures of connected objects.	Incidence of occurrence of technical failures of connected objects.	day 12 postoperatively or discharge from hospital
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient satisfaction	Patient satisfaction measure	1 month
Secondary	Caregiver satisfaction	Caregiver satisfaction measure	day 12 postoperatively or discharge from hospital
Secondary	post-operative complications after discharge from hospital	Incidence of occurrence of post-operative complications after discharge from hospital (phone contact on D30).	1 month