'The Impact of Rhinovirus Infections in Paediatric Cardiac Surgery'
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- post-operative PICU length of stay
研究概览
简要总结
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.
详细描述
Rationale:
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.
Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children (<12 year) with a congenital heart disease undergoing elective cardiac surgery
- •Written informed consent by parents or guardian
排除标准
- •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
结局指标
主要结局
post-operative PICU length of stay
时间窗: participants will be followed for the duration of PICU stay, an expected average of 3,8 days
rhinovirus PCR positive compared to rhinovirus negative patients
次要结局
- Duration of ventilatory support(participants will be followed for the duration of PICU stay, an expected average of 3,8 days)
- mean airway pressure(participants will be followed for the duration of PICU stay, an expected average of 3,8 days)
- FiO2(participants will be followed for the duration of PICU stay, an expected average of 3,8 days)
- peak inspiratory pressure (maximum values)(participants will be followed for the duration of PICU stay, an expected average of 3,8 days)
- positive end expiratory pressure (maximum values)(participants will be followed for the duration of PICU stay, an expected average of 3,8 days)
- Any secondary infection (bacterial, viral and parasitic infections)(participants will be followed for the duration of PICU stay, an expected average of 3,8 days)
- Antibiotic free days (alive at PICU discharge)(participants will be followed for the duration of PICU stay, an expected average of 3,8 days)
- Need of inotropes (inotrope score)(participants will be followed for the duration of PICU stay, an expected average of 3,8 days)
- CRP(participants will be followed for the duration of PICU stay, an expected average of 3,8 days)
- Leukocytes(participants will be followed for the duration of PICU stay, an expected average of 3,8 days)
- Hospital length of stay(participants will be followed for the duration of PICU stay, an expected average of 3,8 days)
研究者
JuttedeVries
M.D. PhD
Leiden University Medical Center