No registrations found.
ID
Source
Brief title
Health condition
rhinovirus rhinovirus
cardiac surgery hart operatie
respiratory infection respiratoire infectie
post operative complications post operatieve complicaties
Sponsors and support
Leiden University Medical Center (LUMC)
Department of paediatric Intensive Care
Dr. J.J.C. de Vries
Leiden University Medical Center (LUMC)
Department of Medical Microbiology
Leiden University Medical Center (LUMC)
Department of paediatric Intensive Care
Dr. J.J.C. de Vries
Leiden University Medical Center (LUMC)
Department of Medical Microbiology
Intervention
Outcome measures
Primary outcome
The primary study parameter is post-operative PICU length of stay in rhinovirus positive compared to rhinovirus negative patients.
Secondary outcome
Secondary outcome parameters are:
• Duration of ventilatory support
• Mechanical ventilation conditions (mean airway pressure, FiO2)
• Antibiotic free days (alive at PICU discharge)
• Need of inotropes (inotrope score)
• Infection parameters
• Hospital length of stay
• Secondary infections
Background summary
This is a prospective single- center observational study in the Leiden University Medical Center in approximately 250 children (<12 years) undergoing elective cardiac surgery, for congenital heart disease.
The parents/guardians of the children will be asked to fill out a questionnaire, to asses respiratory symptoms in the last weeks, before the operation of their child. In the operating theatre, a nasopharyngeal swab will collected. Clinical data will be collected daily during paediatric intensive care admission, and date of discharge from paediatric intensive care unit and from hospital are recorded. If children are still intubated at day 4 a second nasopharyngeal swab and residual blood will be collected. The samples will be tested for rhinovirus with a polymerase chain reaction.
Main study parameter is the paediatric intensive care unit length of stay in per-operative rhinovirus –positive compared to rhinovirus-negative patients.
Study objective
we hypothesize that paediatric patients with per-operative rhinovirus positive Polymerase Chain Reaction (PCR) testing have a longer paediatric intensive care unit (PICU) admission , compared to children who test negative.
Study design
day -1: questionnaire
day 0 (operation day) : collection of nasopharyngeal swab
day 4: if still intubated: nasopharyngeal swab will be sampled and scavenge samples blood will be requested at the chemical laboratory
Intervention
The parents/guardians of the children will be asked to fill out a questionnaire before the operation of their child. In the operating theatre, a nasopharyngeal swab will collected in the children after induction of anaesthesia and thus without any discomfort. Clinical data will be collected daily during paediatric intensive care admission, and date of discharge from PICU and from hospital are recorded. Of all the patients still on mechanical ventilation at day 4, an additional nasopharyngeal swab will be sampled and scavenge samples blood will be requested at the chemical laboratory if available. Rhinovirus PCR will be performed on nasopharyngeal swab and blood to determine shedding and viremia.
R.B.P Wilde
Albinusdreef 2
Leiden 2333 ZA
The Netherlands
r.b.p.wilde@lumc.nl
R.B.P Wilde
Albinusdreef 2
Leiden 2333 ZA
The Netherlands
r.b.p.wilde@lumc.nl
Inclusion criteria
• Children (<12 year) with a congenital heart disease undergoing elective cardiac surgery
• Written informed consent by parents or guardian
Exclusion criteria
• No informed consent from one of the parents (or the legal representative if applicable)
• Anaesthesiologist or cardiopulmonary surgeon postpones surgery based on routine hospital screening
• Emergency surgery
• Pre-operative admission to the neonatology department
• Children not admitted to the intensive care unit after cardiac surgery
• Children undergoing a second cardiac operation during the same intensive care stay
• Children with duct-dependent physiology who remain prostaglandin-dependent after the heart operation (they will be excluded because they will certainly have a prolonged PICU LOS regardless of a possible rhinovirus infection). For example: hypoplastic left heart syndrome following pulmonary artery banding who will remain on prostaglandins until the next staged operation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL4745 |
NTR-old | NTR4999 |
Other | RV-MM-PED-1 : P14.303 |