Cardiopediatric Home Monitoring Tool

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Home monitoring
  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, musc
• Другое usual medical monitoring
  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.

Первичные конечные точки

• Reducing postoperative morbidity and mortality [Срок оценки: 6th month post-op]

Вторичные конечные точки (11)

• Children's quality of life [Срок оценки: 0,1 month, 3 months and 6 months post op]
• Parents' quality of life [Срок оценки: 0,1 month, 3 months and 6 months post op]
• Parental stress [Срок оценки: 0,1 month, 3 months and 6 months post op]
• Children's weight growth [Срок оценки: 1 month, 3 months and 6 months post op]
• Post-traumatic stress syndromes [Срок оценки: 6 months post op]
• Serious non-cardiovascular events [Срок оценки: 6 months post op]
• Factors other than management [Срок оценки: 6 months post op]
• Therapeutic education program [Срок оценки: 6 months post op]
• Acceptability of monitoring for the parents [Срок оценки: 6 months post op]
• Acceptability of the monitoring for the medical teams [Срок оценки: 6 months post op]
• Efficiency [Срок оценки: 6 months post op]

Критерии участия

Критерии включения

• Patients aged between 0 and 36 months inclusive
• With a congenital heart defect
• Underwent cardiac surgery at Nantes University Hospital
• Affiliated to a social security scheme
• Free, informed and written consent of the 2 holders of parental authority

Non Inclusion Criteria:

• Clinical or family situation contraindicating a return home
• Physical inability to connect to the Exolis platform at home
• Insufficient understanding on the part of those with parental authority
• Extracardiac co-morbidities responsible for organ failure requiring repeated
• Hospitalisation for non-cardiovascular reasons (e.g. severe renal failure, neurological neurological deficit, complex immune deficiency, etc).
• Patient and/or parents under legal protection

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• CHU de Nantes — Nantes

Идентификаторы

NCT: NCT06741189 · RC24_0146

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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