Skip to main content
OpenTrials
Completed

NCT Number: NCT04836689

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ventilator Lung; Newborn Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Respiratory Tract Diseases Ventilator-Induced Lung Injury

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam Medical Center

Haifa, 31096, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nasal intermittent positive pressure ventilation (NIPPV).

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.

Primary outcomes

  1. Trans cutaneous CO2 (TCCO2)

    Time frame: During the 3 hours of the study

    Trans cutaneous CO2

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 8, 2021
Registry last updated
Sep 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.