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Ministry of Health THE SOCIALIST REPUBLIC OF VIETNAM National Hospital of Pediatrics   
(Formerly "National Institute of Pediatrics")  
  Hanoi, September 2003


ENDORSEMENT
FOR THE USE OF KIRK EVANS´ KSE CPAP SYSTEM
FOR NEOTOLOGY AT NATIONAL HOSPITAL OF PEDIATRICS

Name: Nguyen Thanh Liem, Ph.D.
Position: Director of National Hospital of Pediatrics, Vietnam


This is to endorse that 15 KSE-CPAP systems, created by the engineer Kirk Evans, are currently in use in the Neonatology Department at NHP from September, 2002 until now and has contributed to the work of rescuing the lives of many babies with respiratory distress in at Neonatology Dept at NHP.

CPAP is one kind of ventilator used for both neonate & adult. In this instance, CPAP is used as a first aid emergency piece of medical equipment for neonates with respiratory distress.
After 1 year of experimental (trial/test) use at our hospital, we know that CPAP has the following advantages:

First: It is effective in curing respiratory distress in neonates, especially for pre-mature infants. This point is very important because KSE-CPAP has reduced the 24-hour infant mortality in the Neonatology Department from 30% in the year 2001 to 10% in the year 2002.

Second: This system´s working mechanism is safe, simple with high reliability (such as temperature, pressure.. etc). We have not seen any case of complication (side-effect) after using this system such as pneumothorax, heamodymic disaster...etc)

Third: KSE CPAP is designed neatly, orderly, is portable and easy to transport. It is designed for low pressure oxygen, and is easily used at clinics which do not have standard oxygen and air pressure system (the KSE-CPAP works with pure oxygen or it can be blended with medical air and operates with a flow of 5 liter/minute).

Fourth: This KSE-CPAP system brings out economic benefits because the material to make it is mostly local so it´s price  (US$1,500)  is much cheaper than the imported CPAP system  (about US$8,000), and it is also easy to fix, repair and do maintenance as well.
That is why this CPAP system can meet the high demand of curing respiratory distress neonates at hospitals as well as at clinics in Vietnam.

In summary, after 1 year being used at Neotology Department at NIP, I consider the KSE-CPAP system is necessary piece of medical equipment for curing respiratory distress neonates and premature baby. And this system has met the high requirement of effectiveness and safety during the test and trial process of at NHP.

Director of National Hospital of Pediatrics
PhD. Nguyen Thanh Liem

(see original document in Vietnamese for signature) 



Nov. 11, 2004
To: Kirk Evans
KSE Medical

From: Steven A. Ringer, MD, PhD
Chief, Division of Newborn Medicine
Brigham and Women´s Hospital
Harvard Medical School

 

Re: KSE-CPAP endorsement 

I have worked closely with Kirk Evans as he developed the KSE CPAP device in Vietnam. It is a truly impressive piece of equipment that has been developed to meet the needs of Vietnam, while still adhering to design principles that rival or exceed those of commercially available CPAP devices from the US or other countries. Based around a water bottle or "bubble" design, the KSE is easily used to effectively deliver CPAP, and mounting evidence suggests that this bubble-type system is in fact more effective for ventilation than simply delivering a static CPAP pressure. The device also includes a well-built, easy to set and read control unit that displays data on humidification and temperature. The simplicity of design of the humidifier unit ensures that it is both easily set-up and monitored. These features make it ideal for use in a both busy neonatal units as well as smaller units with less frequent need for respiratory support. I wholeheartedly endorse the design of the KSE unit, and recommend it highly for use.

 

Steven A. Ringer, MD, PhD
Chief, Division of Newborn Medicine
Brigham and Women´s Hospital
Harvard Medical School
Boston, MA, USA



To: KSE Medical
Hanoi, Vietnam


From: Tove S. Rosen, MD
Professor of Clinical Pediatrics/Neonatology
Columbia University Medical Center, Department of Pediatrics.

 

Kirk,
We have used NCPAP since the early 1960´s. We use NCPAP even in the very low birth weight infants as long as they have a good respiratory effort. The use of NCPAP will increase survival and improve quality of life for premature infants greater than 1500gms with respiratory distress.

Most of these infants in this weight group will improve with just the use of NCPAP. In addition, from our own experience we prefer to use NCPAP instead of standard ventilators when possible as it reduces the incidence of chronic lung disease.

I think the pharyngeal CPAP apparatus that you have constructed in Vietnam is a very valuable and important advance and tool for the survival and treatment of the premature infant. It is easy to use and if it breaks down it can be fixed there. It is also constructed so that it does not need constant nursing attention.

I support wholeheartedly your and the NICU efforts to use CPAP for treatment of respiratory distress. If there is any further information needed please let me know.

 

Tove S. Rosen, MD
Professor of Clinical Pediatrics/Neonatology
Columbia University Medical Center, Department of Pediatrics

 

------------------------------------------------------------------
1Dr. Jen-Tien Wung, MD, FCCM. Professor of Clinical Anesthesiology in Pediatrics, Columbia University. Dr. Wung is considered one of the originators of CPAP use which has been used for more than 30 years.



March 12, 2004


To: Kirk Evans
KSE Medical

From: John Colin Partridge, MD, MPH
Attending Neonatologist, University of California, San Francisco

Dear Kirk,

I write to express my full support for your current project developing low-cost, durable continuous positive airway pressure (CPAP) equipment for use in Vietnam and potentially in other developing countries where mechanical ventilation is rarely accessible for many premature infants with mild to moderate respiratory diseases.

As your are aware, Dr.Chris Stewart, Edna Warnecke (RRT) and I were able to see the equipment you have been developing while we were in Hanoi two months ago and were impressed with the progress you have made, both in research and development, in development of a number of units currently in regular use in the NICU at the National Institute of Pediatrics in Hanoi (NIP), and in--as we understand-a marked reduction in overall mortality statistics since the introduction of more widespread use of CPAP at the NIP.

After carefully reviewing the prototypes you have currently in use at the NIP, I believe that the equipment seems a safe, durable, reasonably low-cost, easily applied and easily understood technological development that can and should be utilized by physicians treating infants for respiratory issues ranging from surfactant deficient respiratory distress syndrome, to apnea of prematurity, and also may help some infants with pneumonia, perinatal asphyxia, delayed fetal lung fluid absorption, or meconium aspiration. The early application of continuous positive pressure ventilation is increasingly looked to as a way to save the lives of premature infants and minimize the risks of chronic lung disease. An added benefit given conditions in Vietnam and other developing countries, is the feasibility and safety of mechanical ventilation when there are fiscal, equipment and staff limitations. The development and distribution of low-cost simple techniques to improve mortality statistics is an important means of decreasing perinatal mortality, which has already been demonstrated by the success of your work at the NIP.

I congratulate you on developing an important, yet feasible, tool by which to improve public health statistics in Vietnam. I also look forward to hearing when you might be ready to expand this to other developing countries in desperate need of simple ways to save prematurely born infants suffering from respiratory distress syndrome.

Wishing you the best of luck in this important venture, sincerely,

John Colin Partridge, MD, MPH
Attending Neonatologist
University of California, San Francisco
Telephone 1-415-206-3088
Fax 1-415-206-3686
cpartridge@sfghpeds.ucsf.edu


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