Primary: To identify whether PCR-proven rhinovirus is a risk factor for prolonged PICU admission in children undergoing cardiac surgery. Secondary: to develop a preoperative algorithm to identify children with increased risk for prolonged PICU…
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is PICU length of stay in per-operative
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
Respiratory infections are considered to carry a potential risk of adverse
events in children undergoing surgery.
Rhinovirus is a common cause of respiratory infections and congenital heart
disease is a risk factor for severe rhinovirus infection. However, we do not
know what the impact of clinical or subclinical rhinovirus infections is on
postoperative course following congenital heart surgery in children.
Based on our clinical experience, one case-controlled study, and a case
reported in the literature , 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 objective
Primary: To identify whether PCR-proven rhinovirus is a risk factor for
prolonged PICU admission in children undergoing cardiac surgery.
Secondary: to develop a preoperative algorithm to identify children with
increased risk for prolonged PICU admission after cardiac surgery.
Study design
This is a prospective single-center observational cohort study in the Leiden
University Medical Center (LUMC).
Study burden and risks
All routine hospital procedures will be followed, including pre-assessment by
the anaesthesiologist and cardiopulmonary surgeon. 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.
Nasopharyngeal sampling bears no clinical risks. Clinical data will be
collected daily during paediatric intensive care admission, and date of
discharge from PICU and from hospital are recorded.
This is an observational study in children already undergoing anaesthesia and
cardiac surgery. The study carries no additional burden, risks or benefit.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
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
•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
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 |
|---|---|
| CCMO | NL51483.058.14 |