GiuliaGiuliaGentle Neonatal Ventilation

Quality for life

Giu

liaThe newest technologyin neonatal nasal ventilation

The goal of the latest research in the field of neonatalintensive care is the use of nasal ventilation in order tominimize or avoid the practice of endotracheal intubation. The beneficial physiological effects of nCPAP (nasalContinuous Positive Airway Pressure) on the respiratorysystem are well known. By applying continuous pressure tothe lungs throughout the respiratory cycle, it preventsalveolar collapse by performing mechanical recruitment ofalveoli; it improves oxygenation, lowers upper airwaysresistance and reduces obstructive apnoea(1). On this basis,nasal CPAP is considered as an effective method ofpreventing extubation failure, it is used in the managementof apnoea of prematurity and is increasingly seen as analternative to intubation for the treatment of respiratorydistress syndrome (RDS) in very low birth weight (VLBW)infants(1). Nasal Intermittent Positive Pressure Ventilation(nIPPV) is a ventilation mode that combines nCPAP withsuperimposed ventilator breaths and can be used as analternative strategy to provide ventilatory support(2).Improvement of the patency of upper airways by creatingintermittently elevated pharingeal pressures, activation ofrespiratory drive by intermittent inflation of the pharynxare the main physiological effects of nIPPV(2). Moreover thisventilation mode can reduce the frequency of apnoeasmore than nCPAP(3).Furthermore it has been observed that if the ventilationrate is close to the infant’s spontaneous rate the nIPPV ismore effective(4). Nowadays even non-invasive modes ofventilation should include the possibility of providingmechanical support in synchrony with the patient’s ownrespiratory efforts.The challenge of Ginevri’s team was to support the latestdevelopments of clinical research with a completelyinnovative device covering the requirements of thescientific community. Therefore, Ginevri has focused itsresearch on innovative ways of enhancing the nCPAPventilatory support by delivering ventilator breaths via thenasal prongs which are synchronized with the infant’srespiratory flow, in nSIPPV and nSIMV modes.In the Giulia neonatal nasal ventilator all the newesttechnologies in the field of neonatal nasal ventilation are atthe disposal of the new-born, who can now be treated withthe most efficient and up to date ventilation techniquesapplied in a gentle way.

Giu

liaSynchronised with the future

Giulia’s advanced technology and its small but highly

sophisticated flow transducer allow it to provide babies with

nasal Continuous Positive Airway Pressure, nasal Synchronized

Intermittent Positive Pressure Ventilation (nSIPPV) and nasal

Synchronized Intermittent Mandatory Ventilation (nSIMV).

The improvement of nasal ventilation techniques permits the

lowering of the rate of intubation in the population of preterm

infants, thus reducing morbidity and costs(1, 5).

The delivery of positive pressure synchronized with the infant’s

own breathing gives an improvement of the pulmonary

mechanics: it has been shown that nSIMV reduces asynchronous

toracoabdominal motion more effectively than nCPAP.

Moreover increases of Tidal Volume (VT) and Minute Volume (VE),

decreases of phasic esophageal pressure deflection (which is an

estimate of infant’s inspiratory effort), PCO2, as well as

Respiratory Rate (RR) are additional remarkable results achieved

with babies treated with nSIPPV(7).

This data suggests that nSIPPV provides more ventilatory support

than nCPAP with less patient respiratory effort(6, 7).

Giu

liaManagement of an openrespiratory system

It’s widely known that the main limit to the

improvement of non invasive ventilation are the

gas leakages through mouth and nostrils, due to

nasal prongs application.

In Giulia neonatal nasal ventilator this limitation

has been successfully overcome.

A sophisticated mathematical algorithm, running

on the internal computer of the ventilator, is able

to detect gas leakages through mouth and nose so

that the management of the main respiratory

parameters, pressure and flow, is now possible even

in an open system.

The Giulia neonatal nasal ventilator encloses an

expiration valve, electronically controlled, by

means of which it is able to regulate maximum and

minimum pressure levels inside the patient circuit

during inspiration as well as expiration phase.

The result of this is a safe and careful

management of the main respiratory

parameters, flow and pressure, even in

an open system.

Giu

liaHow technology makes life easier

The key to the success of patient-triggered ventilation is to

minimize the delay between the beginning of infant’s

spontaneous inspiration and the increase of positive pressure

in the ventilatory circuit, due to the activation of a

mechanical breath.

Moreover the trigger signal has to be a specific signal of

spontaneous respiratory effort and any artefact should be

detected and rejected by the system(8).

For these reasons Ginevri has developed a dedicated flow

sensor with enhanced sensitivity and very low response time

(less than 100 ms).

Therefore, the system requires a minimum inspiratory effort to

be activated, following the rapid increase of flow at the very

beginning of the inspiration. The dead space of the transducer

is remarkably reduced as it is enclosed in the joint between

nasal cannula and Y-piece.

The two synchronized modes (nSIPPV and nSIMV) are

especially intended to perform a smooth transition from

positive pressure support to completely autonomous

breathing. Particularly, in nSIPPV mode the ventilator delivers

a mechanical breath each time a spontaneous breath occurs,

while in nSIMV mode the ventilator assists a defined number

of spontaneous breaths per minute only, thus giving the

possibility of autonomous breathing among synchronized acts.

In this way the use of nSIMV, after nSIPPV, allows complete

baby weaning in a non-invasive way.

The rate of assisted breaths during nSIMV can be adjusted by

the operator. Furthermore, nCPAP can be delivered by GIULIA

neonatal nasal ventilator in order to facilitate gradual

weaning.

In this way any change of baby requirements can be followed

by the caregivers by simply switching the MODE knob.

Giu

liaHow technology makes life easier

The key to the success of patient-triggered ventilation is to

minimize the delay between the beginning of infant’s

spontaneous inspiration and the increase of positive pressure

in the ventilatory circuit, due to the activation of a

mechanical breath.

Moreover the trigger signal has to be a specific signal of

spontaneous respiratory effort and any artefact should be

detected and rejected by the system(8).

For these reasons Ginevri has developed a dedicated flow

sensor with enhanced sensitivity and very low response time

(less than 100 ms).

Therefore, the system requires a minimum inspiratory effort to

be activated, following the rapid increase of flow at the very

beginning of the inspiration. The dead space of the transducer

is remarkably reduced as it is enclosed in the joint between

nasal cannula and Y-piece.

The two synchronized modes (nSIPPV and nSIMV) are

especially intended to perform a smooth transition from

positive pressure support to completely autonomous

breathing. Particularly, in nSIPPV mode the ventilator delivers

a mechanical breath each time a spontaneous breath occurs,

while in nSIMV mode the ventilator assists a defined number

of spontaneous breaths per minute only, thus giving the

possibility of autonomous breathing among synchronized acts.

In this way the use of nSIMV, after nSIPPV, allows complete

baby weaning in a non-invasive way.

The rate of assisted breaths during nSIMV can be adjusted by

the operator. Furthermore, nCPAP can be delivered by GIULIA

neonatal nasal ventilator in order to facilitate gradual

weaning.

In this way any change of baby requirements can be followed

by the caregivers by simply switching the MODE knob.

Giu

liaAccessories

SCH 1000 Humidifier:The Ginevri SCH 1000 servo controlledhumidifier is a piece of equipment designedto provide gas humidification in the patientventilation circuit. The gas thermoregulation is managed by aservo-controlled proportional heating systemthat allows a constant maintenance of thedesired humidity and temperature in thepatient circuit. The humidity can be adjustedby the user on 5 different levels.

Trolley: A complete trolley assembly facilitates the correct use of anyventilation system. Giulia original trolley is designed to allow for the safestmanoeuvrability in the neonatal intensive care unit.With the available range of useful accessories Giulia becomes a completeworkstation at the service of caregivers.

Main TechnicalSpecifications

CONTROLSContinuous flow range 0-18 L/minInspiratory time 0.1-2 secExpiratory time 0.1-60 secVentilation freq, 1-150 breaths/minInsp flow 0-18 L/minPIP 0-60 mbarCPAP/PEEP 0-10 mbarFiO2 0.21-1 Trigger mechanism Flow

OPERATING MODESnCPAP Yes nSIMV Yes nSIPPV Yes

MANUAL INSPIRATION Yes

MONITORED PARAMETERSPIP Yes (mbar)FLOW Yes (l/min)CPAP/PEEP Yes (mbar)Ventilation freq 1-400 breaths/minInsp time 0.1-2 secExp time 0.1-60 secFiO2 Yes

ALARMSLow PIP Yes High PIP Yes Continuous Pressure Yes Low battery YesPower failure YesFiO2 Optional

GRAPHICS CAPABILITY 10,4 “ TFT OLOUR SCREEN

INTERFACING FLOPPY DISK

LINE POWER 220 VAC

AUXILIARY POWER YES

DIMENSIONSW x D x H 31 x 30 x 43 cm

WEIGHT 6 kg

CE MARK Yes

REFERENCES:

1. A.G. De Paoli, et al. Nasal CPAP for neonates. What we do know in 2003? Arch Dis Child Fetal Neonatal Ed 2003; 88:F168.2. A Greenough, et al. Respiratory support. In: A. Greenough, A.D. Milner: Neonatal Respiratory Disorders (Second Edition) – Ed. Arnold, London 2003; p. 152.3. B. Lemyre, et al. Nasal intermittent positive pressure ventilation (NIPPV) versus nasal continuous positive pressure (NCPAP) for apnoea of prematurity.

Cochrane Database of Systematic Reviews, 2001.4. C. Moretti, et al. Prolonged intermittent positive pressure ventilation by nasal prongs in intractable apnoea of prematurity. Acta Paediatrica Scandinavica 1981; 70:211.5. A.G. De Paoli, et al. Nasal continuous positive airway pressure versus nasal intermittent positive pressure ventilation for preterm neonates: a systematic review an

meta-analysis. Acta Pediatr 2003; 92:70.6. N.M. Kiciman, et al. Thoracoabdominal motion in newborns during ventilation delivered by endotracheal tube or nasal prongs. Pediatr Pulmonol 1998; 25:175.7. C. Moretti, et al. Comparing the effects of nasal synchronized intermittent positive pressure ventilation (NSIPPV) versus nasal continuous positive airway pressure (NCPAP)

after extubation in very low birth weight infants. Early Hum Dev 1999; 56:167.8. C. Moretti, et al. Ventilazione meccanica convenzionale. In: C. Moretti – Disturbi respiratori del neonato: dalla patogenesi alla terapia – Ed. Masson, Milano 2002; p.113.

Authorized Distributor

Quality for life

GINEVRI srlVia Cancelliera, 25/b

00041 Cecchina (Roma) - Italy

Tel.: +39 06 93 459 330Fax: +39 06 93 459 393e-mail: mail@ginevri.com

www.ginevri.com

Since 1954 Ginevri is a leading designer, manufacturer andworld-wide distributor of electromedical equipment forneonatal and pediatric care. Ginevri’s policy has always been topromote the best quality, safety, user friendliness and easymaintenance of its products for the full satisfaction of itscustomers: public and private hospitals.

ISO 9001 2000ISO13485:2003 0051

The specifications in this catalogue are indicative. Ginevri, the company,reserves the right to make changes, without further notice, to the productsdescribed within this catalogue in order to improve reliability, function or design.