|- candidate number||6612|
|- NTR Number||NTR2067|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-okt-2009|
|- Secondary IDs||2009-213 MEC|
|- Public Title||NAVA study.|
|- Scientific Title||NAVA on the pediatris and neonatology: practical application with oncomplicated artificial respiration for chlidren from 0-18 years? A feasibility study.|
|- hypothesis||NAVA (neurally adjusted ventilatory assist) is a newform of artificial respiration, based on the electrical activity of the diafragma. We want to investigate wether there are fysiological differences between the conventional mode and NAVA.|
|- Healt Condition(s) or Problem(s) studied||Premature infants, Respiration, Children, Neonates|
|- Inclusion criteria||Pediatric ward: |
1. Fi02% < 40%;
2. PC < 15 cm H20 above PEEP, PRVC Tv 6-8 ml/kg ( peak pressure < 20 cm H20;
3. PEEP <8 cm H20;
4. Spontaneus triggering.
1. Fi02% < 30%, PC < 15 cm H20 above PEEP;
2. PEEP < 6 cm H20;
3. Gestational age> 29 weeks or weight > 1250 grams.
|- Exclusion criteria||Pediatric ward:|
1. ECMO treatment;
2. No informed consent from parents;
3. Neurological illness or trauma;
5. Oesophagus atresia;
6. Extubation within 24 hours.
1. No informed consent from parents;
2. Hemodynamic instability;
3. IVH, asphyxia, convulsions;
4. Sedation, therofore no spontaneus breathing;
5. Possible extubation within 24 hours.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||18-okt-2009|
|- planned closingdate||3-jan-2010|
|- Target number of participants||10|
|- Interventions||NAVA working mechanism: |
NAVA stands for neurally adjusted ventilatory assist. This mode of
mechanical ventilation is based on the neural respiratory output from
the patient itself.
This new mode is only available on the Servo I, produced by Maquet Solna
The act of breathing depends on rhytmic discharge from the respiratory
center of the brain. This discharge travels along the phrenis nerve and
excites the diaphragm muscle cells. The diaphragm contracts and as a
result there is a pressure drop in the lungs causing air to flow into
Respiratory support is given on the basis of measurement of the
electrical excitation of the diafragm ( Edi signal). A naso-gastric
tube, wich has multiple electrode rings placed on the distal part of the
tube, is put in the proper position ( the electrodes will be placed at
diafragm level.). The electrical signal of the diafragm then can be
detected and a software program filters the signal from artefacts ( eg
the electrical excitation of the heart). The Edi signal is displayed on
the monitor of the Servo I.
Because both the patient and the machine act upon the same signal there
is an instantaneous support from the machine.
NAVA is synchronous with the patient's own respiratory frequency and the
support level is propotional too the magnitude of the Edi signal. This
means that if the signal is stronger the support will be higher and
vice-versa. This new mode of ventilatory support may give the patient
improved synchrony, lung protection and patient-comfort.
First we insert an Edi catheter, which measures the electricalsignal at diafrgam level.
Then we will observe the fysiological, respiratory parameters and take a comfortscore.
|- Primary outcome||1. Fysiological measurements: Heartrate, saturation, bloodpressure;|
2. Respiratory measurements: Peakpressure, mean pressure, oxygen demand, resp frequenty, NAVA-level, Edimax, Edi min.
|- Secondary outcome||1. Comfortscore;|
2. Position of the catheter.
|- Timepoints||1. Fysiological and respiratory parameters every minute;|
2. Comfortscore every half our;
3. Position of catheter, when a chest X-ray is taken.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||dr. S.P. Bol|
|- CONTACT for SCIENTIFIC QUERIES||dr. S.P. Bol|
|- Sponsor/Initiator ||Erasmus Medical Center, Sophia Children's Hospital, Department of Neonatology Intensive Care, Erasmus Medical Center, Sophia Children's Hospital|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, Sophia Children's Hospital|
|- Brief summary||In this study we want to see if NAVA is applicable in the neonatal and pediatric patient. We want to investigate what fysiological differences there might be between NAVA and a conventional mode.|
|- Main changes (audit trail)|
|- RECORD||15-okt-2009 - 11-jan-2011|