The primary objective is to compare the incidence of patient-ventilator-asynchrony during paediatric mechanical ventilation using ventilator waveforms with PVA detected by using the ventilator waveforms in combination with diaphragm and intercostal…
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Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to compare the incidence of
patient-ventilator-asynchrony during paediatric mechanical ventilation using
ventilator waveforms with PVA detected by using the ventilator waveforms in
combination with diaphragm and intercostal EMG.
Secondary outcome
-Level and time course of incidence PVA.
-Time course of distribution of type of PVA.
-Level and time course of diaphragm EMG.
-Level and time course of intercostals EMG.
-Level and time course of phase angle distribution.
-Effect of imposed work of breathing on incidence PVA.
Background summary
Patient-ventilator asynchrony (i.e. a mismatch in the interaction between the
patient*s needs and the ventilator) can lead to considerable patient distress,
lead to increase used of sedatives and it also impedes the effectiveness of the
ventilator in decreasing respiratory work. Surprisingly, relatively little is
known about its incidence in mechanically ventilated children. Previously, we
observed that in 30 percent of all breaths some form of patient-ventilator
asynchrony occurred. Currently, PVA can be detected in three different ways. At
present, the most readily available method to detect PVA is analyzing the
waveforms (the pressure-time, flow-time and volume-time waveform) displayed by
the ventilator to detect PVA. However, for a true assessment of the occurrence
of PVA it is mandatory to know if there is any patient effort before the
ventilator delivers a breath. This can be most reliable method by detected by
observing oesophageal pressure waveforms. Alternatively, electrical activity of
the respiratory muscles has also been used to study PVA. EMG activity *
especially of the diaphragm * also indicates patient effort. We hypothesized
that the occurrence of PVA in mechanically ventilated children is higher than
reported during visual inspection of the pressure * time and flow * time
tracings when this is combined with non-invasive diaphragmatic and intercostal
muscle EMG monitoring.
Study objective
The primary objective is to compare the incidence of
patient-ventilator-asynchrony during paediatric mechanical ventilation using
ventilator waveforms with PVA detected by using the ventilator waveforms in
combination with diaphragm and intercostal EMG.
Study design
This is a prospective observational study without invasive measurements in a 20
bed tertiary paediatric intensive care facility at the Beatrix Children*s
hospital/University Medical Centre Groningen. The study will start February
2015 and is completed by March 31, 2018.
Study burden and risks
There are a priori no specific benefits for the patients who participate in
this observational study. There are no risks associated with this study, based
upon the following argument:
1. Patients are not subjected to care procedures other than the usual
standard-of-care in the intensive care.
2. For the intercostal and diaphragm EMG measurements 5 electrodes must be
placed on the chest; The electrodes are fully comparable with the electrodes
routinely used for ECG monitoring; hence they pose no risks.
3. For the RIP measurements two elastic bands are placed circumferentially
around the patient*s chest and abdomen. These bands pose no risks.
4. For imposed work of breathing measurements a catheter will be inserted in
the endotracheal tube. This catheter will pose no risks.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
Mechanically ventilated children who are able to trigger the ventilator aged 0-18 years.
Exclusion criteria
-premature birth with gestational age corrected for post-conceptional age less than 40 weeks
-congenital or acquired neuromuscular disorders
-congenital or acquired central nervous system disorders with depressed respiratory drive
-severe traumatic brain injury (i.e. Glasgow Coma Scale < 8)
-congenital or acquired damage to the phrenic nerve
-congenital or acquired paralysis of the diaphragm
-use of neuromuscular blockade
-chronic lung disease
-severe pulmonary hypertension
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 |
---|---|
CCMO | NL46097.042.13 |