Cardiopediatric Home Monitoring Tool
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Nantes University Hospital
- Enrollment
- 186
- Locations
- 1
- Primary Endpoint
- Reducing postoperative morbidity and mortality
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 0 Minutes to 36 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- Not provided
Arms & Interventions
home monitoring group
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.
Intervention: usual medical monitoring (Other)
standard group
The usual medical monitoring for the first six months postoperatively is standardized between the 4 university hospital centres concerned and consists of :
- 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.
Intervention: usual medical monitoring (Other)
home monitoring group
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.
Intervention: Home monitoring (Other)
Outcomes
Primary Outcomes
Reducing postoperative morbidity and mortality
Time Frame: 6th month post-op
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.
Secondary Outcomes
- Children's quality of life(0,1 month, 3 months and 6 months post op)
- Parents' quality of life(0,1 month, 3 months and 6 months post op)
- Parental stress(0,1 month, 3 months and 6 months post op)
- Children's weight growth(1 month, 3 months and 6 months post op)
- Post-traumatic stress syndromes(6 months post op)
- Serious non-cardiovascular events(6 months post op)
- Factors other than management(6 months post op)
- Therapeutic education program(6 months post op)
- Acceptability of monitoring for the parents(6 months post op)
- Acceptability of the monitoring for the medical teams(6 months post op)
- Efficiency(6 months post op)