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Crossover bedside clinical study to examine relative tidal volume delivery during nasal intermittent positive pressure ventilation (NIPPV) and directly compare the RAM® infant cannula to a nasal continuous positive airway pressure (nCPAP) delivery system in vivo. The study population will consist of preterm neonates with mild respiratory insufficiency who are receiving NIPPV, non-invasive neurally adjusted ventilatory assist (NIV NAVA), or nCPAP.
Bedside crossover study of neonates with mild respiratory distress receiving NIPPV. Infants serve as their own controls and are randomized to initial interface of either RAM® infant cannula or Miniflow® nCPAP prongs. Infants are instrumented with the following monitoring equipment: Edi orogastric tube to measure electrical activity of the diaphragm, transcutaneous monitor to measure transcutaneous CO2 and O2, pulse oximeter to measure heart rate and oxygen saturation, and respiratory inductance plethysmography (RIP) bands around the chest and abdomen to measure breathing movements and relative Vt (arbitrary units, a.u.). Data are continuously and simultaneously acquired using a data acquisition system. After 10 minutes of stabilization, infants receive 5 minutes of NIPPV on each of a sequence of four commonly used pressure settings (expressed as peak inspiratory pressure / positive end expiratory pressure): 16/5, 16/8, 20/5, 20/8. This sequence is not randomized and is constant between interfaces. Subjects are then placed on the alternate interface, and the sequence is repeated. Events ("breaths") are separated into 3 types: patient effort synchronized with NIPPV breaths (type I), NIPPV breaths without patient effort (type II), and patient effort without NIPPV breaths (type III).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nCPAP prongs | Active Comparator |
| |
| Infant cannula | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal interface | Device | Randomized to initial interface of nCPAP prongs or infant cannula |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative tidal volume delivery, breath type I | Relative tidal volume measured in arbitrary units (AU) via RIP bands during synchronized breaths | 1 hour |
| Relative tidal volume delivery, breath type II | Relative tidal volume measured in arbitrary units (AU) via RIP bands during ventilator-driven breaths | 1 hour |
| Relative tidal volume delivery, breath type III | Relative tidal volume measured in arbitrary units (AU) via RIP bands during patient-driven breaths | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator pressure delivery | 1 hour | |
| Ventilator flow delivery | 1 hour | |
| Heart rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashley Lynch, M.D. | Contact | 501-412-0988 | allynch@uams.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Recruiting | Little Rock | Arkansas | 72202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38129599 | Derived | Lynch AL, Matlock DN, Akmyradov C, Weisner MD, Beck J, Sinderby C, Courtney SE. Tidal volume delivery during nasal intermittent positive pressure ventilation: infant cannula vs. nasal continuous positive airway pressure prongs. J Perinatol. 2024 Feb;44(2):244-249. doi: 10.1038/s41372-023-01846-7. Epub 2023 Dec 21. |
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| 1 hour |
| Oxygen saturation | 1 hour |
| Transcutaneous carbon dioxide tension | 1 hour |
| Transcutaneous oxygen tension | 1 hour |