SAFETY AND EFFICACY OF
THE Vapotherm™2000i IN THE NEONATAL POPULATION.
by Shyan Sun, MD,
Robert Tero, RRT, Saint Barnabas Medical Center, Livingston, N
J.
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. Patient weights are:
Weight
grams
Number
of Neonates
<
500
3
501
- 750
32
751
- 1000
27
1001
- 1250
20
1251
- 1500
10
>
1500
17
Total
109
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.
“Partial funding
was provided by Vapotherm for this study”.
