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Using diaphragm EMG in patient ventilator asynchrony


- candidate number19211
- NTR NumberNTR4706
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-jul-2014
- Secondary IDsPed.PVA.EMG.1 Lokaal protocol nummer M13.143975 ID toegekend door lokale METc
- Public TitleUsing diaphragm EMG in patient ventilator asynchrony
- Scientific TitleDoes the combination of ventilator waveforms and diaphragm and intercostal EMG improve the identification of patient-ventilator-asynchrony in mechanically ventilated children compared with waveforms alone?
- ACRONYMn/a
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedVentilation
- Inclusion criteria- all patients who require mechanical ventilation aged 0-18 years
- patients should be able to trigger the ventilator with a pre-set flow trigger of 1 liter/min
- 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
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-okt-2014
- planned closingdate30-sep-2015
- Target number of participants83
- Interventionsn/a
- Primary outcomeIncidence of patient-ventilator-asynchrony.
- 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.
- TimepointsDaily recordings (2x15 minutes)
- Trial web siten/a
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD R.G.T. Blokpoel
- CONTACT for SCIENTIFIC QUERIESMD R.G.T. Blokpoel
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summaryPatient-ventilator asynchrony can lead to considerable patient distress, lead to increase used of sedatives. Surprisingly, relatively little is known about its incidence in mechanically ventilated children.
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. Recruitment: the Netherlands
- Main changes (audit trail)
- RECORD30-jul-2014 - 19-aug-2014


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