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We hypothesize that a home monitoring program combined with routine postoperative care significantly reduces morbidity and mortality after neonatal and pediatric cardiac surgery. This project differs from the previously published experiences by (a) providing an innovative telemedicine solution via the use of validated measurement sensors, (b) an alert system based on individualized standards, established for each care pathway, and (c) a protocolized response from medical teams in the management of alerts generated by the home monitoring tool.
Affecting 12-million people worldwide and 7,400 newborns/year in France, congenital heart defects (CHD) are the leading cause of birth defects and a major cause of morbidity and mortality in childhood.
It is (a) a growing patient population, due to an increase in birth prevalence and survival, and (b) a major public health issue, due to a substantial use of healthcare resources and a dramatic impact on quality of life. CHDs concerned by the OSCAR project are rare diseases (prevalence <1/2000 births) operated on at birth or in infancy. These CHDs expose affected newborns/infants to the risk of major cardiovascular events (fainting, cyanosis, arrhythmias) and/or rapid cardiac decompensation occurring at home in the postoperative period, justifying close ambulatory monitoring to detect early warning signs of complication or decompensation (such as oxygen desaturation, accelerated heart rate, poor weight gain, altered tone, etc.)
This risk is particularly high in certain critical postoperative situations, such as when the physiology of a single ventricle is palliated by a shunt (modified Blalock-Taussig systemic-pulmonary anatomy), or in the intermediate period (interstage) between two palliative surgeries in a Norwood program. In view of the high ambulatory mortality (12-20% in current series) during the interstage of a Norwood program, some expert centers around the world have opted not to discharge operated neonates home, preferring to keep in-hospital monitoring during 4 to 5 months, until stage 2, thus reducing mortality during this critical period. In Anglo-Saxon countries, an outpatient monitoring program has been developed as an alternative for these vulnerable patients, sometimes accompanied by a telemedicine solution, greatly reducing postoperative mortality. This type of outpatient follow-up program does not exist in France.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard group | Active Comparator | The usual medical monitoring for the first six months postoperatively is standardized between the 4 university hospital centres concerned and consists of :
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| home monitoring group | Experimental | In addition to the usual post-operative monitoring, OSCAR home monitoring will enable key parameters to be transmitted to the medical team at a discontinuous rate (once a day for 4 weeks, then once a week for 20 weeks) via a brief questionnaire (smartphone application) and measurement sensors (weight, oxygen saturation, heart rate) linked to an interface, from the first day the patient returns home until the 6th month post-operatively. The values entered will be automatically compared with individualized standards established for each child at a multidisciplinary meeting, and any deviation from the standard will generate an alert. and the response of the medical teams will be protocolized. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home monitoring | Other | The key parameters (heart rate, arterial oxygen saturation, weight) will be measured at home using the measurement tools used by the parents, and tele-transmitted at a discontinuous rate, i.e. once a day for 4 weeks, then once a week for 20 weeks. The measurement tools will be given to the family before discharge from the hospital ward. These parameters will be entered into the Exolis platform, in addition to a very brief questionnaire designed to provide information about the child's diet, muscle tone and any medication he or she is taking. taken by the child. An alert will be automatically generated for the pediatric cardiology team if the data transmitted by the measurement sensors deviates from an individualized standard, defined for each child and/or each care pathway at the multidisciplinary consultation meeting before the child returns home. The response will be standardized on the basis of a protocol shared by the 4 investigating centers. |
| Measure | Description | Time Frame |
|---|---|---|
| Reducing postoperative morbidity and mortality | The main objective is to evaluate the impact of home monitoring in reducing postoperative morbidity and mortality in patients aged 0 to 36 months who have undergone MCC. | 6th month post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Children's quality of life | Assess the impact of OSCAR surveillance by comparing the 2 groups: Children's quality of life during the postoperative period. | 0,1 month, 3 months and 6 months post op |
| Parents' quality of life |
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Inclusion Criteria:
Non Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alban-Elouen Baruteau, Pr | Contact | +33 | +33240087742 | albanelouen.baruteau@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Recruiting | Nantes | France |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D015190 | Blood Glucose Self-Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| usual medical monitoring | Other | During the first 4 weeks: a weekly consultation including a record of intercurrent events (malaise, cyanosis, hyperthermia, eating difficulties), a record of weight and vital constants (oxygen saturation, heart rate), an examination of the sternotomy or thoracotomy scar, a clinical cardiovascular examination, a 12-lead electrocardiogram and a transthoracic echocardiogram. During the following 20 weeks: a consultation at 1, 3 and 6 months including the same assessment procedures. |
|
Assess the impact of OSCAR surveillance by comparing the 2 groups:
Parents' quality of life during the postoperative period
| 0,1 month, 3 months and 6 months post op |
| Parental stress | Assess the impact of OSCAR surveillance by comparing the 2 groups: Parental stress and family impact during the postoperative period | 0,1 month, 3 months and 6 months post op |
| Children's weight growth | Assess the impact of OSCAR surveillance by comparing the 2 groups: Children's weight growth during the postoperative period | 1 month, 3 months and 6 months post op |
| Post-traumatic stress syndromes | Assess the impact of OSCAR surveillance by comparing the 2 groups: The prevalence of post-traumatic stress syndromes in parents at the postoperative month. | 6 months post op |
| Serious non-cardiovascular events | Assess the impact of OSCAR surveillance by comparing the 2 groups: The rate of serious non-cardiovascular events (in order to study a potential delay in the management of these events in the group with OSCAR monitoring group due to increased follow-up). | 6 months post op |
| Factors other than management | To study the impact of factors other than management (OSCAR monitoring versus management) on the parents' quality of life, parental stress and family impact family impact, children's weight gain, and the presence of post-traumatic stress post-traumatic stress disorder in the parents 6 months after the operation. | 6 months post op |
| Therapeutic education program | Evaluate the conditions for implementing OSCAR surveillance by assessing : The relevance of the OSCAR therapeutic education program (ETP) for the parents in the group concerned. | 6 months post op |
| Acceptability of monitoring for the parents | Evaluate the conditions for implementing OSCAR surveillance by assessing : The acceptability of monitoring for the parents in the group concerned. | 6 months post op |
| Acceptability of the monitoring for the medical teams | Evaluate the conditions for implementing OSCAR surveillance by assessing : The acceptability of the monitoring for the medical teams (investigating hospital investigating hospital medical teams and the child's routine care medical teams). | 6 months post op |
| Efficiency | Evaluate the conditions for implementing OSCAR surveillance by assessing : its efficiency. | 6 months post op |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D000085263 | Self-Testing |
| D012648 | Self Care |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |