Influence of Respiratory Rate Settings on CO2 Levels During Nasal Intermittent Positive Pressure Ventilation (NIPPV).

Study Overview
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Brief Summary
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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
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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.

Official Title
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Influence of Respiratory Rate Settings on CO2 Levels During Nasal Intermittent Positive Pressure Ventilation (NIPPV).

Conditions
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Ventilator Lung; Newborn

Intervention / Treatment
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* Device: nasal intermittent positive pressure ventilation (NIPPV).


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 30 breaths per minutes<br>Using NIPPV with rate of 30 for 1 hour. Measuring trans cutaneous CO2 | Device: nasal intermittent positive pressure ventilation (NIPPV).<br>* 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.<br>|
| Other: 10 breaths per minute<br>Using NIPPV with rate of 10 for 1 hour. Measuring trans cutaneous CO2 | Device: nasal intermittent positive pressure ventilation (NIPPV).<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trans cutaneous CO2 (TCCO2) | Trans cutaneous CO2 | During the 3 hours of the study |