NAVA Use in Preterm Neonates With Respiratory Distress Syndrome
Neurally Adjusted Ventilatory Assist [NAVA] Versus Conventional Ventilation in Preterm Neonates With Respiratory Distress Syndrome
A randomized controlled clinical trial evaluates the efficacy of NAVA in comparison with conventional ventilation (SIMV) in preterm neonates with respiratory distress syndrome.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Numerous methods for ventilating patients are available in both invasive and noninvasive modes. However, patient-ventilator asynchrony has been a persistent problem .
Neurally adjusted ventilatory assist (NAVA) improves patient-ventilator synchrony in preterm infants, leading to reduced work of breathing, lower peak inspiratory pressures (PIP), and decreased oxygen requirements compared to conventional ventilation . This improved synchrony results in better oxygenation and ventilation, potentially reducing the risk of lung injury and other complications associated with mechanical ventilation in preterm neonates . . NAVA is a mechanical ventilation modality in which the ventilator assists the patient breath in proportion to and in synchrony with the electrical activity of the diaphragm (EAdi) .EAdi is a fast and accurate reflection of phrenic nerve activity arising from central respiratory centers.
During NAVA use, a nasogastric or orogastric tube with electrodes is placed in the patient to detect changes in the diaphragm's electrical activity (Edi) more than 60 times per second . The diaphragm contracts as the phrenic nerves deliver the signal to breathe. The ventilator measures the strength of this activity and provides an appropriately sized breath based on the patient's own effort .
As synchronization in NAVA is independent of pressure or flow trigger and independent of leaks, NAVA has a strong potential to increase invasive ventilation efficiency .
Patient-ventilator asynchrony occurs when the ventilator fails to detect the patient's breath or detects it too late in the breathing cycle, leading to complications that include increased sedation, discomfort, and possibly higher morbidity and mortality .
With NAVA, the patient is actually controlling the trigger, delivery and cycling of every breath. The ventilator becomes completely synchronous with the patient avoiding the undesirable outcomes of patient-ventilator asynchrony. Since the Edi is a reflection of neural respiratory output, ventilator breath delivery is in synchrony with neural control of ventilation .
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Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Rania Ali El-Farrash
- Telefonní číslo: +201222208550
Studijní místa
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Abbasia
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Cairo, Abbasia, Egypt, 11517
- Nábor
- Neonatal Intensive Care Units (NICUs), Ain Shams University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Gestational age ≤ 34 weeks.
- Neonates that have RDS according to clinical and radiological findings
- Neonates requiring invasive mechanical ventilation.
Exclusion Criteria:
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1) Preterm neonates that have respiratory distress due to causes other than respiratory distress syndrome including transient tachypnea of new born , congenital pneumonia and sepsis. 2)Central and peripheral conditions that limit the respiratory drive, as well as diaphragmatic anatomical defects in patients with an intact respiratory drive, comprise the contraindications to NAVA
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Examples are the following:
- Central disorder: paralytic drug use, respiratory drive suppression due to heavy sedation or brain injury.
- Peripheral disorder: phrenic nerve injury, paralytic agent administration.
- Structural (anatomical) disorder: esophageal atresia, diaphragmatic hernia. 3) Cardiac patients including aortic coarctation , double outlet right ventricle (DORV), Tetralogy of Fallot and Transposition of the great arteries (TGA). 4) Surgical patients including gastroschisis , omphalocele , tracheoesophageal fistula and congenital diaphragmatic hernia (CDH).
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Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Experimental: Neurally Adjusted Ventilatory Assist [NAVA] .
After documenting parental consent, preterm neonates with respiratoryd by insufficiency randomly ventilated on NAVA will be assessed by transcranial Doppler ultrasonographic examination and echocardiography. |
ventilator settings will be recorded such as: NAVA level , Edi peak , peep, apnea time |
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Aktivní komparátor: Active Comparator: Synchronized Intermittent Mandatory Ventilation (SIMV)
After documenting parental consent, preterm neonates with respiratoryd by insufficiency randomly ventilated on SIMV will be assessed by transcranial Doppler ultrasonographic examination and echocardiography. |
ventilator settings will be recorded such as peep , PIP , Fio2 |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Echocardiography
Časové okno: baseline and after 24 hours from enrollment in the study
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to assess any structural cardiac anomalies, the patency of ductus arteriosus, right ventricular output (RVO), left ventricular output (LVO), and superior vena cava (SVC) flow, ejection fraction (EF) and pulmonary pressure performed by a specialized echocardiographist. |
baseline and after 24 hours from enrollment in the study
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Transcranial ultrasonography Doppler
Časové okno: baseline and after 24 hours from enrollment in the study
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applied to the middle cerebral artery to provide an estimate of cerebral blood flow performed by a specialized pediatric radiologist . |
baseline and after 24 hours from enrollment in the study
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Duration of admission
Časové okno: up to 8 weeks or till patient discharged or die which comes first
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To document total number of days of admission |
up to 8 weeks or till patient discharged or die which comes first
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Mortality rate
Časové okno: up to 8 weeks or till patient death which comes first
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To document incidence of mortality during hospitalization |
up to 8 weeks or till patient death which comes first
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Incidence of feeding intolerance
Časové okno: up to 8 weeks or till patient discharged or die which comes first
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Percentage of Patients who developed feeding intolerance |
up to 8 weeks or till patient discharged or die which comes first
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Days to reach full intake
Časové okno: up to 8 weeks or till patient discharged or die which comes first
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Number of days needed by each patient to reach full intake |
up to 8 weeks or till patient discharged or die which comes first
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Chest x ray change
Časové okno: upon NICU admission and one hour after enrollment in the study .
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Chest x ray grading of RDS performed to patient before and after the assigned mode to compare lung aeration degree |
upon NICU admission and one hour after enrollment in the study .
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NAVA use in preterm neonates
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Studuje lékový produkt regulovaný americkým FDA
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