Nasal Noninvasive NAVA in the Very Low Birth Weight Infant
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Women's Studies |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | Any - 1 |
| Updated: | 8/11/2018 |
| Start Date: | February 2013 |
| End Date: | December 2018 |
| Contact: | Tarah J Colaizy, M.D. |
| Email: | tarah-colaizy@uiowa.edu |
| Phone: | 319-356-7096 |
Nasal Noninvasive NAVA Provides Ventilation in the Very Low Birth Weight Infant
The purpose of this study is to determine if a new type of mechanical ventilation, or
breathing machine (called neurally adjusted ventilatory assist or NAVA), will provide
additional support to infants who were born prematurely. Investigators are looking to
determine if in two hours infants who weighed less than 1500 grams or 3 pounds 5 ounces, will
demonstrate a decrease in the amount of carbon dioxide (the gas that humans exhale) dissolved
in their blood as compared to prior to starting the study. This will be accomplished by
enrolling infants who are stable on their current type of mechanical breathing that provides
a constant air flow into the infant. This type of mechanical support helps keep the lungs
inflated but does not help remove carbon dioxide. This study will change the type of
mechanical support to a type of support called neurally adjusted ventilatory assist or NAVA.
This type of mechanical support detects when the infant is breathing in by having electrical
sensors on a feeding tube that is placed into the stomach through the nose or mouth. These
electrical sensors detect when the diaphragm or the muscle that helps humans breath is trying
to take a breath in. When the NAVA ventilator senses the attempt to breath, it provides
additional air flow to make the effort of breathing easier. The ventilator will be attached
to a tube or cannula that is placed into the infant's nose. After two hours of being on the
NAVA ventilator a repeat measure of carbon dioxide in the blood will be performed by taking a
small amount of blood from the infant's heel.
breathing machine (called neurally adjusted ventilatory assist or NAVA), will provide
additional support to infants who were born prematurely. Investigators are looking to
determine if in two hours infants who weighed less than 1500 grams or 3 pounds 5 ounces, will
demonstrate a decrease in the amount of carbon dioxide (the gas that humans exhale) dissolved
in their blood as compared to prior to starting the study. This will be accomplished by
enrolling infants who are stable on their current type of mechanical breathing that provides
a constant air flow into the infant. This type of mechanical support helps keep the lungs
inflated but does not help remove carbon dioxide. This study will change the type of
mechanical support to a type of support called neurally adjusted ventilatory assist or NAVA.
This type of mechanical support detects when the infant is breathing in by having electrical
sensors on a feeding tube that is placed into the stomach through the nose or mouth. These
electrical sensors detect when the diaphragm or the muscle that helps humans breath is trying
to take a breath in. When the NAVA ventilator senses the attempt to breath, it provides
additional air flow to make the effort of breathing easier. The ventilator will be attached
to a tube or cannula that is placed into the infant's nose. After two hours of being on the
NAVA ventilator a repeat measure of carbon dioxide in the blood will be performed by taking a
small amount of blood from the infant's heel.
Baseline Data Collection:
Demographic data: Patient gestational age at delivery, maternal betamethasone therapy, APGAR
scores, admission weight, receipt of surfactant administered, age at extubation, time since
extubation, current post menstrual age, and current weight.
Baseline vitals and ventilation mode: Heart rate, blood pressure, FiO2, oxygen saturations,
transcutaneous partial pressure of carbon dioxide (TCO2) and current mode of ventilation will
be recorded four times in a one minute period and the values average to minimize normal
variation. Intervention time will be manipulated to begin no later than one hour after the
previous feeding, as to minimize interruption of feedings to no greater than 30 minutes.
Safety Safety: TCO2 monitor will be attached to the infant and the device will be calibrated
according to protocol (reference TCO2 monitor manual). Carbon dioxide diffusion through the
skin will be monitored continuously during the intervention (Bromley 08) to avoid periods of
hypo or hypercarbia.
Edi Catheter placement: Edi catheter size will be selected according to infant's weight and
length. It will be inserted according to manufacturer's guidelines and adjustments will be
made to optimize positioning (reference NAVA manual).
NAVA settings:
Infants will be maintained on previous level of PEEP or calculated PEEP, rounding up to whole
numbers. Initial NAVA level will be determined by starting with an initial NAVA level of 0.5
microvolts/cm of H20. The NAVA level will then be adjusted either by increasing or decreasing
to generate a PIP that is a minimum of 8 cm of H2O greater than the current PEEP. Apnea alarm
will be set at 5 seconds, which will initiate the NAVA back up setting if no electrical
activity is detected by the Edi catheter. Back up NAVA settings will be set with a PIP of 12
cm of H20 greater than current PEEP, respiratory rate of 60 breaths per minute (RR) and
inspiratory time of 0.5 seconds. Fraction of inspired oxygen (FiO2) will be adjusted to keep
infant's oxygen saturations within previously established clinical parameters.
Study Intervention Procedure and Data Collection:
At initiation of intervention, and at time 30, 60, 90, and 120 minutes, heart rate (HR),
respiratory rate (RR), tidal volume (TV), minute ventilation, FiO2, oxygen saturations, peak
Edi and PIP will be recorded four times in a one minute period and the values average to
minimize normal variation. Current NAVA settings, TCO2, and blood pressure (BP) will also be
recorded. At 60 minutes of intervention if the TCO2 level has not decreased by 5 torr from
baseline or has risen, the current NAVA level will be increased by 50%. At 90 minutes if the
TCO2 level has not decreased by 5 torr from baseline or has risen; the NAVA level will be
increased by 50% from the current level. At the completion of the study (120 minutes or pCO2
outside of established limits) the HR, RR, BP, TV, minute ventilation, FiO2, oxygen
saturations, peak Edi and PIP will be recorded four times in a one minute period and the
values average to minimize normal variation. A capillary blood gas will be obtained according
to standard unit protocol with a warmed heel.
Demographic data: Patient gestational age at delivery, maternal betamethasone therapy, APGAR
scores, admission weight, receipt of surfactant administered, age at extubation, time since
extubation, current post menstrual age, and current weight.
Baseline vitals and ventilation mode: Heart rate, blood pressure, FiO2, oxygen saturations,
transcutaneous partial pressure of carbon dioxide (TCO2) and current mode of ventilation will
be recorded four times in a one minute period and the values average to minimize normal
variation. Intervention time will be manipulated to begin no later than one hour after the
previous feeding, as to minimize interruption of feedings to no greater than 30 minutes.
Safety Safety: TCO2 monitor will be attached to the infant and the device will be calibrated
according to protocol (reference TCO2 monitor manual). Carbon dioxide diffusion through the
skin will be monitored continuously during the intervention (Bromley 08) to avoid periods of
hypo or hypercarbia.
Edi Catheter placement: Edi catheter size will be selected according to infant's weight and
length. It will be inserted according to manufacturer's guidelines and adjustments will be
made to optimize positioning (reference NAVA manual).
NAVA settings:
Infants will be maintained on previous level of PEEP or calculated PEEP, rounding up to whole
numbers. Initial NAVA level will be determined by starting with an initial NAVA level of 0.5
microvolts/cm of H20. The NAVA level will then be adjusted either by increasing or decreasing
to generate a PIP that is a minimum of 8 cm of H2O greater than the current PEEP. Apnea alarm
will be set at 5 seconds, which will initiate the NAVA back up setting if no electrical
activity is detected by the Edi catheter. Back up NAVA settings will be set with a PIP of 12
cm of H20 greater than current PEEP, respiratory rate of 60 breaths per minute (RR) and
inspiratory time of 0.5 seconds. Fraction of inspired oxygen (FiO2) will be adjusted to keep
infant's oxygen saturations within previously established clinical parameters.
Study Intervention Procedure and Data Collection:
At initiation of intervention, and at time 30, 60, 90, and 120 minutes, heart rate (HR),
respiratory rate (RR), tidal volume (TV), minute ventilation, FiO2, oxygen saturations, peak
Edi and PIP will be recorded four times in a one minute period and the values average to
minimize normal variation. Current NAVA settings, TCO2, and blood pressure (BP) will also be
recorded. At 60 minutes of intervention if the TCO2 level has not decreased by 5 torr from
baseline or has risen, the current NAVA level will be increased by 50%. At 90 minutes if the
TCO2 level has not decreased by 5 torr from baseline or has risen; the NAVA level will be
increased by 50% from the current level. At the completion of the study (120 minutes or pCO2
outside of established limits) the HR, RR, BP, TV, minute ventilation, FiO2, oxygen
saturations, peak Edi and PIP will be recorded four times in a one minute period and the
values average to minimize normal variation. A capillary blood gas will be obtained according
to standard unit protocol with a warmed heel.
Inclusion Criteria:
- birth weight less than 1,500 grams
- Clinical history of respiratory distress syndrome treated with surfactant
- Chronological age greater than or equal to seven days
- 48 hours post-extubation or greater
- Medically stable per primary medical team
- Receiving ventilatory support on one of the following systems via nasal pharyngeal
tube or nasal prongs:continuous positive airway pressure (CPAP), intermittent
mechanical ventilation (IMV), or neutrally adjusted ventilatory assistance (NAVA)
- Receiving ventilatory support via high flow nasal cannula if the flow is large enough
to provide a positive end expiratory pressure (PEEP) of 6 as defined by PEEP of 6 =
0.68 * weight (kg) + 0.92
- Capillary blood gas via heel stick within 24 hours that demonstrates a pH of less than
or equal to 7.35 and/or a partial pressure of carbon dioxide (pCO2) greater than or
equal to 45 mmHg
Exclusion criteria:
- Severe congenital abnormalities
- Grade III or IV interventricular hemorrhage.
We found this trial at
2
sites
101 Jessup Hall
Iowa City, Iowa 52242
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Tarah T Colaizy, MD, MPH
Phone: 319-356-3508
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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200 Hawkins Drive
Iowa City, Iowa 52242
Iowa City, Iowa 52242
Principal Investigator: Tarah T Colaizy, MD, MPH
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