The primary objective is to study the level and time course of pulmonary pro- and anti-inflammatory mediators in children who need 2 hours of mechanical ventilation because they are undergoing an elective procedure.
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the level and time course of pulmonary inflammatory
mediators including G-CSF, GM-CSF, IFN-, IFN-, IL-1, IL-1RA, IL-2, IL-2R, IL-4,
IL-5, IL-6, IL7, IL-8, IL-10, IL-12, IL-13, IL-15, IL-17, TNF-alpha
Secondary outcome
Level and time course of systemic inflammatory mediators (i.e. G-CSF, GM-CSF,
IFN-, IFN-, IL-1, IL-1RA, IL-2, IL-2R, IL-4, IL-5, IL-6, IL7, IL-8, IL-10,
IL-12, IL-13, IL-15, IL-17, TNF-alpha)
Level and time course of pulmonary 1-antitrypsin concentrations
Level and time course of pulmonary sRAGE concentrations
Level and time course of systemic sRAGE concentrations
Background summary
Nowadays mechanical ventilation is standard for a pediatric intensive care unit
(PICU), where 64% of the patient*s need mechanical ventilation for at least 24
hours With the development of the ventilation, there also came a critical
insight that ventilation can have the opposite effect. Instead of giving the
lungs time to heal, it can induce ventilator-induced lung injury. The
consequence for mechanical ventilation on healthy lungs remains unclear.
Several studies are suggesting that mechanical ventilation also causes VILI in
children who do not have lung pathology. The long-term effects of ventilation
children on developing healthy lungs are also not known.
Study objective
The primary objective is to study the level and time course of pulmonary pro-
and anti-inflammatory mediators in children who need 2 hours of mechanical
ventilation because they are undergoing an elective procedure.
Study design
Prospective observational with invasive measurements
Study burden and risks
The risks associated with this study are minimal based on the following
arguments: a) during the catheterisation, patients are fully anesthetised
(including paralyzed) and under constant tight observation, so any change in
vital parameters is noted immediately, b) blood samples are only taken from an
indwelling arterial catheter that is inserted for the catheterisation and c)
endotracheal suctioning is routinely performed in mechanically ventilated
patients; for this study the suctioning specimens are collected to measure the
pulmonary inflammatory response so no extra suctioning procedures will be
performed
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
• Written Informed consent obtained
Exclusion criteria
• Patients with a history of allergic or respiratory diseases
• Known chromosomal disorder
• Known immunological disorders
• Recent episode of mechanical ventilation
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 |
|---|---|
| Other | Aangevraagd |
| CCMO | NL59436.042.16 |