To test the hypothesis that NMBAs in mechanically ventilated children younger than 12 years of age with moderate-to-severe paediatric ARDS (i.e. oxygenation index > 12 and PEEP > 5 cmH2O despite adequate sedation) reduce the transpulmonary…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Transpulmonary pressure
Secondary outcome
Haemodynamic profile, respiratory system mechanics, metrics for oxygenation,
ventilation and deadspace, and diaphragmatic activity and occurrence of
pendelluft
Background summary
Paediatric acute respiratory distress syndrome (ARDS) is a manifestation of
severe, life-threatening lung injury. Care for paediatric patient is mainly
supportive and based on what works in adults and personal experiences,
including the use of mechanical ventilation. However, differences in lung
physiology and immunology between (young) children and adults suggests that
adaptation of adult practices into paediatrics may not be justified. Recently,
we found that introduction of neuromuscular blocking agents (NMBA) resulted in
immediate improvement in oxygenation without affecting tidal volume
distribution. The mechanisms underlying this observation are unknown.
Study objective
To test the hypothesis that NMBAs in mechanically ventilated children younger
than 12 years of age with moderate-to-severe paediatric ARDS (i.e. oxygenation
index > 12 and PEEP > 5 cmH2O despite adequate sedation) reduce the
transpulmonary pressure, decrease the occurrence of patient - ventilator
dyssynchrony by reducing the respiratory rate and prevent the occurrence of
pendelluft.
Study design
Prospective observational study with invasive measurements
Study burden and risks
The risks associated with this study are minimal based on the following
arguments: patients in the intensive care unit are under constant tight
observation, so any change in vital parameters is noted immediately.
Furthermore, patients with severe lung injury are commonly deeply sedated,
blood samples are only taken from an indwelling arterial catheter, which is
already in place for clinical purposes, insertion of the oesophageal catheter
poses the same risk as insertion of nasogastric feeding tubes that are inserted
during routine care; our unit has advanced experience with inserting these
catheters, and electrical impedance tomography and electromyography
measurements are non-invasive by nature. It is important to study the effects
of neuromuscular blocking agents on patient outcome in the paediatric context.
There are numerous differences in lung physiology and immunology between
(young) children and adults indicating that adaptation of adult practices into
paediatrics may not be justified.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
Informed consent
Age younger than 12 years
Need for mechanical ventilation with tidal volume 5 - 8 mL/kg ideal bodyweight and a mimum PEEP level of 5 cmH2O
Early moderate - to - severe paediatric acute respiratory distress syndrome originating from any cause:
• Acute onset of disease, and
• Oxygenation index > 12, and
• One or more (bilateral) infiltrates on chest radiograph, and
• No evidence of left ventricular failure or fluid overload, and
• Within the first 48 hours of diagnosis of PARDS
Indication for continuous infusion of NMBAs at discretion of the attending physician
Exclusion criteria
No informed consent
Continuous administration of neuromuscular blockade prior at the time of meeting the criteria for PARDS
Chronic respiratory failure on home ventilation
Intracranial hypertension
Bone marrow transplantation
Immunocompromised patients (congenital or acquired)
Pre-existing pulmonary hypertension
Congenital heart disease with left - to - right shunting
Cyanotic congenital heart disease
Withdrawal of life - sustaining treatment
Prematurity (gestational age less than 44 weeks when assessed for eligibility)
History of congenital neuromuscular disorder
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL59838.042.16 |
| OMON | NL-OMON23189 |