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

Ventilator Lung; Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04836689
• Other study ID #: RMB-0490-20
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: September 2022
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Month

Eligibility

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.

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Ventilator Lung; Newborn

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trans cutaneous CO2 (TCCO2)	Trans cutaneous CO2	During the 3 hours of the study