Study Author: Andrea Blay, Consultant Nurse-Critical Care

Hypothesis: The ability to deliver high flow humidified oxygen in ward environments outside critical care units enables reduced intensive care admissions and the need for intubation and ventilation.

Study Size: The Critical Care Outreach Team has treated over 60 patients with various pathophysiology and clinical presentations with Vapotherm.

Significance and Potential Applications: One early case in particular is that of a 50-year-old male HIV patient. The patient was non-responsive on the re-breathe oxygen system and intolerant of BiPAP and due to continued hypoxia and respiratory distress was placed back on the 15l re-breathe face mask.

Results: Due to increasing respiratory distress and associated tachypnoea Vapotherm therapy was commenced at 15l/minute with 100% FiO2, adjusted according to peripheral saturations. By day six oxygen requirements were reduced to 40% and weaning from Vapotherm completed a few days later

Conclusions: To be able to oxygenate patients effectively during critical illness via nasal cannulae has increased our ability to manage this group of patients on the wards as well as providing us with an alternative to non-invasive CPAP and BiPAP® therapies especially in the non-compliant patient group who cannot tolerate facial masks.

Study Authors: Shyan Sun MD, Robert Tero, RRT

Study Site: Saint Barnabas Medical Center, Livingston, NJ.

Purpose: To determine the safety and efficacy of the Vapotherm 2000i high flow nasal cannula in the neonatal population.

Method: Data was collected on neonates while being treated with the Vapotherm system. Neonates with respiratory compromise, apnea of prematurity, and premature lungs were treated using supplemental oxygen and high humidity by water vapor. Vapotherm was used either as a primary treatment for mild to moderate cases of respiratory distress syndrome in lieu of traditional nasal CPAP or as a post mechanical ventilation (post-extubation) treatment in place of nasal CPAP.

Results: We treated and recorded data on 109 neonates during 2002 and 2003. Total days of treatment are 2070 days or 5.7 years of therapy time equivalents.

Average individual patient time on Vapotherm in 2002 is 30 days ± 13 and 2003 is 18 ± 15 days. During treatment there were no evidence of barotrauma, CPAP belly, or nosocomial infection. There were three deaths not associated with respiratory complications rather due to sepsis and multiple organ failure onsets from birth. There was no nasal trauma noted and flow rates ranged from 2 - 8 lpm. Diameter of the nasal cannula is 2 mm. No nasal mucus plugging was noted.

Discussion: High flow nasal cannula via the Vapotherm delivering supplement breathing gas is a safe adjunct to the respiratory support of the pre- term infant. Gas is delivered at BTPS in the form of water vapor which is at equilibrium with the lung in water content (44 mg/L) and partial pressure (47 mmHg). The small NC allows for an open flow system unlike nasal CPAP reducing the risk of iatrogenic injury to the patient.

Conclusion: These results indicate that Vapotherm is a safe and effective adjunct to support infants with respiratory compromise.

The EasyOne Spirometer has gained wide acceptance in Australia since its launch in March 2002.

The EasyOne Spirometer was developed by ndd Medical Technologies and utilises a unique ultrasonic transit-time measurement principle which was originally designed for use by the MIR and NASA Space Crews.

The Ultrasonic Flow Sensors measure the flow of air in and out of the patient's lungs. Ultrasonic flow measurement eliminates problems associated with traditional methods of flow measurement and makes the EasyOne spirometer a fast, reliable, and accurate diagnostic device. There are no moving parts and no need for calibration or maintenance.

The EasyOne Spirometer has been specified by GOLD (Global Initiative for Chronic Obstructive Lung Disease) for their BOLD project which has developed a standardised protocol to obtain information about the prevalence and burden of COPD, and will implement this protocol in a number of countries throughout the world. All countries have been encouraged to plan prevalence surveys. The BOLD Operations Centre will provide coordination, training, materials, and data analysis. To date, China and Turkey have both commenced BOLD studies with many more countries, including Australia, to follow over the next two years.

Excerpt from BOLD Protocol - "To optimize quality control in the BOLD study, sites are required to use the NDD EasyOne Spirometer. This spirometer has been approved by the pulmonary function reading center (PFRC) as meeting predetermined performance criteria relating to reliability of measurement, suitability for field use, and ease of access to data" The pulmonary function reading center (PFRC) for the BOLD project is the LDS (Latter Day Saints) Hospital in Utah, USA.

In addition, the EasyOne Spirometer has become the first office spirometer to meet the NLHEP (National Lung Health Education Program) Criteria in the U.S. Excerpt from NLHEP Website News, January 2005 - "An office spirometer manufacturer has successfully completed the Spirometer Review Process (SRP) to meet NLHEP criteria for office-based spirometers. As defined by NLHEP, an office-based spirometer is one that is appropriate for use in diagnosing obstructive lung disease in the primary care setting. This company is the first manufacturer to pass the SRP". For more information click on the NLHEP Link in the Quick Links section of the newsletter.

Applications of the EasyOne Spirometer in Australia now include: COPD, Asthma and Epidemiological Research, use in Emergency Departments, Respiratory Wards, Respiratory Investigation Units, COPD Outreach Programmes, Respiratory Outpatient Clinics, Cystic Fibrosis Clinics, Occupational Health Clinics, Community Health Centres and General Pratice.

The innovative and widely used Sidestream® nebuliser is now available in two new configurations aimed at making it easier to administer aerosol therapy to mechanically ventilated patients. The Sidestream® nebuliser delivers rapid treatments at optimal particle size (MMAD of 3 microns) with a low residual volume and is guaranteed to circuit pressures of up to 100 cmH2O.

The Infant Flow Advance (Bi-Level Nasal CPAP) Driver will be superceded within the next three months and is to be replaced by the new Infant Flow SiPAP Comprehensive system from VIASYS Healthcare who have been working on this project since taking over the E.M.E business.

Infant Flow SiPAP was designed specifically for non- invasive support and the new expanded capabilities allows application to a broader range of patients who may otherwise not be candidates for non-invasive respiratory support from CPAP alone. Infant Flow SiPAP provides multiple solutions for successful non- invasive treatment including NCPAP and BiPhasic with time and patient triggered modes.

Infant Flow SiPAP will feature Simple Touch Screen Operation, Enhanced Displays of Pressure / Time Graphics, Monitored Parameter Screen, Improved Patient Triggering and Enhanced Indicators for Signalling Alarm Priority.

In addition, the Infant Flow Generator (patient interface) with its unique fluidics has been redesigned to include a swivel head and an integral expiratory line with the objective of improving the fixation of the generator to enhance the comfort of the interface for the infant.