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

Not Applicable

Completed

• Conditions: Ventilator Lung; Newborn
• Interventions: Device: nasal intermittent positive pressure ventilation (NIPPV).

• Registration Number: NCT04836689
• Lead Sponsor: Rambam Health Care Campus

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.

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-08
• Primary Completion: 2022-08-01
• Status Verified: 2022-09
• Study Completion: 2022-09-01
• Last Update Submitted: 2022-09-20
• Last Update Posted: 2022-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
10 breaths per minute	nasal intermittent positive pressure ventilation (NIPPV).	Using NIPPV with rate of 10 for 1 hour. Measuring trans cutaneous CO2
30 breaths per minutes	nasal intermittent positive pressure ventilation (NIPPV).	Using NIPPV with rate of 30 for 1 hour. Measuring trans cutaneous CO2

Primary Outcome Measures

Name	Time	Method
Trans cutaneous CO2 (TCCO2)	During the 3 hours of the study	Trans cutaneous CO2

Trial Locations

Locations (1)

Rambam Medical Center; 🇮🇱 Haifa, Israel