Clinical trial NCT04236271: TELEsurveillance of Patients in PostopErative Bridge surgeryAge CoronairE
Official title: TELEsurveillance of Patients in PostopErative Bridge surgeryAge CoronairE, Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass
Keywords: connected objects
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: GFI
First posted: 2020-01-22
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: An open, monocentric prospective pilot study evaluating the reliability of post-operative coronary bypass surgery telemonitoring tools and their diagnostic performance for the detection of postoperative complications.
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Blood pressure measured by connected armband
timeFrame: day 12 postoperatively or discharge from hospital
measure: Temperature measured by connected thermometer
timeFrame: day 12 postoperatively or discharge from hospital
measure: Heartbeat measured by connected electrocardiogram
timeFrame: day 12 postoperatively or discharge from hospital
measure: scar appearance
timeFrame: day 12 postoperatively or discharge from hospital
measure: pain measured
timeFrame: day 12 postoperatively or discharge from hospital
Secondary outcomes:
measure: Connected armband measurements
timeFrame: day 12 postoperatively or discharge from hospital
measure: Connected thermometer measurements.
timeFrame: day 12 postoperatively or discharge from hospital
measure: Connected electrocardiogram
timeFrame: day 12 postoperatively or discharge from hospital
measure: photography of scar
timeFrame: day 12 postoperatively or discharge from hospital
measure: analog visual pain scale
timeFrame: day 12 postoperatively or discharge from hospital
measure: Technical failures of connected objects.
timeFrame: day 12 postoperatively or discharge from hospital
measure: alert algorithms for the diagnosis of postoperative complications
timeFrame: day 12 postoperatively or discharge from hospital
measure: Time between surgery and when the patient meets inclusion criteria
timeFrame: day 8 postoperatively
measure: self-measurements performed by the patient
timeFrame: day 12 postoperatively or discharge from hospital
measure: items completed by the patient in the application
timeFrame: day 12 postoperatively or discharge from hospital
measure: Patient satisfaction
timeFrame: 1 month
measure: Caregiver satisfaction
timeFrame: day 12 postoperatively or discharge from hospital
measure: post-operative complications after discharge from hospital
timeFrame: 1 month
Other outcomes:
Locations:
city: Paris
country: France
facility: Cimadevilla
Study officials:
affiliation: APHP
name: Claire Cimadevilla
role: PRINCIPAL_INVESTIGATOR
References: