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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-09-01

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.

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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.

Conditions

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Ventilator Lung; Newborn

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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30 breaths per minutes

Using NIPPV with rate of 30 for 1 hour. Measuring trans cutaneous CO2

Group Type OTHER

nasal intermittent positive pressure ventilation (NIPPV).

Intervention Type DEVICE

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.

10 breaths per minute

Using NIPPV with rate of 10 for 1 hour. Measuring trans cutaneous CO2

Group Type OTHER

nasal intermittent positive pressure ventilation (NIPPV).

Intervention Type DEVICE

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.

Interventions

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nasal 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.

Intervention Type DEVICE

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.

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No