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Trials / Completed

CompletedNCT04236271

TELEsurveillance of Patients in PostopErative Bridge surgeryAge CoronairE

TELEsurveillance of Patients in PostopErative Bridge surgeryAge CoronairE, Pilot Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
33 (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

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

Timeline

Start date
2020-03-13
Primary completion
2022-06-30
Completion
2022-12-31
First posted
2020-01-22
Last updated
2023-05-15

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04236271. Inclusion in this directory is not an endorsement.