Skip to main content
OpenTrials
Completed

NCT Number: NCT04236271

TELEsurveillance of Patients in PostopErative Bridge surgeryAge CoronairE

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cimadevilla

Paris, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 18 years of age or older at baseline
  • Patient for whom isolated coronary bypass was performed
  • 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
  • From the 4th day after surgery, ECG of the day in sinus rhythm
  • From the 4th day after surgery, hemoglobin> 8g / dl, creatinine clearance> 30ml / min, during a blood sample of less than 24 hours
  • From the 4th day after the operation, no significant abnormalities during a chest X-ray less than 24 hours
  • 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)

Treatment and study plan

connected objects

Device

a combination of connected devices for measuring physiological parameters and for clinical self-assessment by the patient, for early postoperative coronary bypass surgeries.

Primary outcomes

  1. Blood pressure measured by connected armband

    Time frame: day 12 postoperatively or discharge from hospital

    The Evolution of blood pressure will be measured daily by connected armband, from day 4 postoperatively to discharge from hospital.

  2. Temperature measured by connected thermometer

    Time frame: day 12 postoperatively or discharge from hospital

    The Evolution of Temperature will be measured daily by connected thermometer, from day 4 postoperatively to discharge from hospital.

  3. Heartbeat measured by connected electrocardiogram

    Time frame: day 12 postoperatively or discharge from hospital

    The heartbeat will be measured daily by connected electrocardiogram, from day 4 postoperatively to discharge from hospital.

  4. scar appearance

    Time frame: day 12 postoperatively or discharge from hospital

    The Evolution of scar appearance will be measured daily by photography, from day 4 postoperatively to discharge from hospital.

  5. pain measured

    Time frame: day 12 postoperatively or discharge from hospital

    The Evolution of pain will be measured daily by an electronic analog visual pain scale, from day 4 postoperatively to discharge from hospital.

Secondary outcomes

  1. Connected armband measurements

    Time frame: day 12 postoperatively or discharge from hospital

    Concordance between connected armband blood pressure measurements, and reference measurements performed by the health care team during hospitalization.

  2. Connected thermometer measurements.

    Time frame: day 12 postoperatively or discharge from hospital

    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.

  3. Connected electrocardiogram

    Time frame: day 12 postoperatively or discharge from hospital

    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.

  4. photography of scar

    Time frame: day 12 postoperatively or discharge from hospital

    Concordance between photography of scar appearance (flow, inflammation), and reference measurements performed by the health care team during hospitalization.

  5. analog visual pain scale

    Time frame: day 12 postoperatively or discharge from hospital

    Concordance between connected an electronic analog visual pain scale and reference measurements performed by the health care team during hospitalization.

  6. Technical failures of connected objects.

    Time frame: day 12 postoperatively or discharge from hospital

    Incidence of occurrence of technical failures of connected objects.

  7. alert algorithms for the diagnosis of postoperative complications

    Time frame: day 12 postoperatively or discharge from hospital

    Sensitivity and specificity of alert algorithms for the diagnosis of postoperative complications (pericardial effusion, heart failure, infection, atrial fibrillation).

  8. Time between surgery and when the patient meets inclusion criteria

    Time frame: day 8 postoperatively

    Time between surgery and when the patient meets the clinical, ECG, biological, radiographic and echocardiographic inclusion criteria

  9. self-measurements performed by the patient

    Time frame: day 12 postoperatively or discharge from hospital

    Proportion of self-measurements performed by the patient using the connected objects among all self-measurements requested.

  10. items completed by the patient in the application

    Time frame: day 12 postoperatively or discharge from hospital

    Proportion of items completed by the patient in the application among the total of items to be completed.

  11. Patient satisfaction

    Time frame: 1 month

    Patient satisfaction measure

  12. Caregiver satisfaction

    Time frame: day 12 postoperatively or discharge from hospital

    Caregiver satisfaction measure

  13. post-operative complications after discharge from hospital

    Time frame: 1 month

    Incidence of occurrence of post-operative complications after discharge from hospital (phone contact on D30).

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • GFI

Registry information

Official study title

TELEsurveillance of Patients in PostopErative Bridge surgeryAge CoronairE, Pilot Study

Acronym: TELE-PEACE

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 22, 2020
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.