Ventilator Lung; Newborn
Conditions
Brief summary
Infants will be monitored by TcCO2 during three consecutive time periods of one hour each on a high and low rate of NIPPV, when in a stable condition. NIPPV rate will start high/low, changed to low/high and switched back to starting rate.
Detailed description
This will be a prospective, crossover observational study that will be performed at Rambam NICU. Infants will be monitored by TcCO2 during three consecutive time periods of one hour each on a high and low rate of NIPPV, when in a stable condition. NIPPV rate will start high/low, changed to low/high and switched back to starting rate.
Interventions
DEVICEnasal intermittent positive pressure ventilation (NIPPV).
NIPPV will be administered using Leoni (Heinen&Löwenstein, Bad Ems, Germany) and RAM cannula (Neotech, Valencia, CA). After initial setting and before routine blood gas testing, tcCO2 will be connected and calibrated. We will use SenTec digital monitor (SenTec AG, Therwil, Switzerland). Correlation/agreement between the tcCO2 and PCO2 will be assessed and documented in each infant. For Each infant we will get 2 set of data: Change in measurements when changing from 30 bpm to 10 bpm, and change in measurements when changing from 10 bpm to 30 bpm At the end of each hour, before rate change, we will document the following measurements:TcCO2, FiO2, saturation, the infant's respiratory rate (as measured in the monitor), number of apneas, bradycardia (heart rate\<100 bpm), saturation\<90% and\>94% episodes (as measured in the monitor), 1-hour saturation histogram clasification.
Sponsors
Rambam Health Care Campus
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Infants will be monitored by TcCO2 during three consecutive time periods of one hour each on a high and low rate of NIPPV, when in a stable condition. NIPPV rate will start high/low, changed to low/high and switched back to starting rate
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Months
Healthy volunteers
No
Inclusion criteria
* Gestational age 240 to 336. * At least 6 hours of stabilized NIPPV settings, i.e. minor changes in settings (FiO2 ≤0.10, PIP≤ 2.0 cmH2O, RR≤ 5 brm). * At least 6 hours of stabilized tcCO2, i.e. ≤5 mmHg variation. * At least 6 hours from surfactant administration. * Parental consent
Exclusion criteria
* If NIPPV set rate is 10 bpm and tcCO2 related pCO2 is\<40mmHg. * If NIPPV set rate is 30 bpm and tcCO2 related pCO2 is\>60mmHg. * Unstable infants due to acute conditions (sepsis. IVH), or congenital malformations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trans cutaneous CO2 (TCCO2) | During the 3 hours of the study | Trans cutaneous CO2 |
Countries
Israel
Outcome results
None listed