TELEsurveillance of Patients in PostopErative Bridge surgeryAge CoronairE

NCT04236271 | Completed

• 1 other identifier: APHP180485
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Bypass

Keywords

connected objects

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (13)

• Connected armband measurements

  day 12 postoperatively or discharge from hospital

• Connected thermometer measurements.

  day 12 postoperatively or discharge from hospital

• Connected electrocardiogram

  day 12 postoperatively or discharge from hospital

• photography of scar

  day 12 postoperatively or discharge from hospital

• analog visual pain scale

  day 12 postoperatively or discharge from hospital

Study Arms (1)

patient

EXPERIMENTAL

interventional group

Device: connected objects

Interventions

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.

patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age or older at baseline
• Patient for whom isolated coronary bypass was performed
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• GFI: collaborator

Study Sites (1)

Cimadevilla

Paris, France

Location

Study Officials

• Claire Cimadevilla

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 22, 2020
• Study Start: March 13, 2020
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: May 15, 2023

Record last verified: 2023-05

Locations

FR (1)