Cimadevilla
Paris, France
NCT Number: NCT04236271
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.
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All sexes
Interventional
Not applicable
Paris, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
a combination of connected devices for measuring physiological parameters and for clinical self-assessment by the patient, for early postoperative coronary bypass surgeries.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: day 12 postoperatively or discharge from hospital
Incidence of occurrence of technical failures of connected objects.
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).
Time frame: day 8 postoperatively
Time between surgery and when the patient meets the clinical, ECG, biological, radiographic and echocardiographic inclusion criteria
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.
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.
Time frame: 1 month
Patient satisfaction measure
Time frame: day 12 postoperatively or discharge from hospital
Caregiver satisfaction measure
Time frame: 1 month
Incidence of occurrence of post-operative complications after discharge from hospital (phone contact on D30).
Assistance Publique - Hôpitaux de Paris
Other
TELEsurveillance of Patients in PostopErative Bridge surgeryAge CoronairE, Pilot Study
Acronym: TELE-PEACE
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.
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