Coronary Artery BypassTELE-PEACENCT04236271
TELEsurveillance of Patients in PostopErative Bridge surgeryAge CoronairE
A study testing connected objects in people with Coronary Artery Bypass, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass
- What is being tested?
- connected objects
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 13 Mar 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TELEsurveillance of Patients in PostopErative Bridge surgeryAge CoronairE, Pilot Study
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.
Read more
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.
Read the 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
- Coronary Artery Bypass
- Being tested
- connected objects
- Keywords
- connected objects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
connected objectsDevice
a combination of connected devices for measuring physiological parameters and for clinical self-assessment by the patient, for early postoperative coronary bypass surgeries.
| Study group | Role | What they receive |
|---|---|---|
| patient | Experimental | interventional group Receives: Device: connected objects |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: day 12 postoperatively or discharge from hospital
Secondary outcomes (13)
Connected armband measurements
Concordance between connected armband blood pressure measurements, and reference measurements performed by the health care team during hospitalization.
Measured: day 12 postoperatively or discharge from hospital
Connected thermometer measurements.
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.
Measured: day 12 postoperatively or discharge from hospital
Connected electrocardiogram
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.
Measured: day 12 postoperatively or discharge from hospital
photography of scar
Concordance between photography of scar appearance (flow, inflammation), and reference measurements performed by the health care team during hospitalization.
Measured: day 12 postoperatively or discharge from hospital
analog visual pain scale
Concordance between connected an electronic analog visual pain scale and reference measurements performed by the health care team during hospitalization.
Measured: day 12 postoperatively or discharge from hospital
Technical failures of connected objects.
Incidence of occurrence of technical failures of connected objects.
Measured: day 12 postoperatively or discharge from hospital
alert algorithms for the diagnosis of postoperative complications
Sensitivity and specificity of alert algorithms for the diagnosis of postoperative complications (pericardial effusion, heart failure, infection, atrial fibrillation).
Measured: day 12 postoperatively or discharge from hospital
Time between surgery and when the patient meets inclusion criteria
Time between surgery and when the patient meets the clinical, ECG, biological, radiographic and echocardiographic inclusion criteria
Measured: day 8 postoperatively
self-measurements performed by the patient
Proportion of self-measurements performed by the patient using the connected objects among all self-measurements requested.
Measured: day 12 postoperatively or discharge from hospital
items completed by the patient in the application
Proportion of items completed by the patient in the application among the total of items to be completed.
Measured: day 12 postoperatively or discharge from hospital
Patient satisfaction
Patient satisfaction measure
Measured: 1 month
Caregiver satisfaction
Caregiver satisfaction measure
Measured: day 12 postoperatively or discharge from hospital
post-operative complications after discharge from hospital
Incidence of occurrence of post-operative complications after discharge from hospital (phone contact on D30).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start13 Mar 2020
- Primary completion30 Jun 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery BypassStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- GFI
- Responsible party
- Sponsor
- Investigators
- Claire Cimadevilla, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236271
- Sponsor's protocol ID
- APHP180485
- Acronym
- TELE-PEACE
- Status last verified
- May 2023
- First submitted
- 10 Jan 2020
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TELEsurveillance of Patients in PostopErative Bridge surgeryAge CoronairE, Pilot Study
- ClinicalTrials.gov ID
- NCT04236271
- Acronym / sponsor ID
- TELE-PEACE / APHP180485
- Conditions
- Coronary Artery Bypass
- Keywords
- connected objects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- GFI
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| patient | Experimental | Device: connected objectsinterventional group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- Patients at high risk of complications:
- Refusal to sign the consent. Protected persons (tutorship, safeguard of justice)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| connected objectsa combination of connected devices for measuring physiological parameters and for clinical self-assessment by the patient, for early postoperative coronary bypass surgeries. | Device | patient |
Primary outcome
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.
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.
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.
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.
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.
13 secondary outcomes
Connected armband measurements
Time frame: day 12 postoperatively or discharge from hospital
Connected thermometer measurements.
Time frame: day 12 postoperatively or discharge from hospital
Connected electrocardiogram
Time frame: day 12 postoperatively or discharge from hospital
photography of scar
Time frame: day 12 postoperatively or discharge from hospital
analog visual pain scale
Time frame: day 12 postoperatively or discharge from hospital
Technical failures of connected objects.
Time frame: day 12 postoperatively or discharge from hospital
alert algorithms for the diagnosis of postoperative complications
Time frame: day 12 postoperatively or discharge from hospital
Time between surgery and when the patient meets inclusion criteria
Time frame: day 8 postoperatively
self-measurements performed by the patient
Time frame: day 12 postoperatively or discharge from hospital
items completed by the patient in the application
Time frame: day 12 postoperatively or discharge from hospital
Patient satisfaction
Time frame: 1 month
Caregiver satisfaction
Time frame: day 12 postoperatively or discharge from hospital
post-operative complications after discharge from hospital
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Cimadevilla principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing connected objects in people with Coronary Artery Bypass, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure measured by connected armband (time frame: day 12 postoperatively or discharge from hospital). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.