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

NCT04836689 | Completed

• 1 other identifier: RMB-0490-20
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Lung; Newborn

Outcome Measures

Primary Outcomes (1)

• Trans cutaneous CO2 (TCCO2)

  Trans cutaneous CO2

  During the 3 hours of the study

Study Arms (2)

30 breaths per minutes

OTHER

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

Device: nasal intermittent positive pressure ventilation (NIPPV).

10 breaths per minute

OTHER

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

Device: nasal intermittent positive pressure ventilation (NIPPV).

Interventions

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.

10 breaths per minute; 30 breaths per minutes

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Medical Center

Haifa, 31096, Israel

Location

Related Publications (1)

• Hochwald O, Borenstein-Levin L, Dinur G, Jubran H, Littner Y, Breuer M, Kugelman A. The effect of changing respiratory rate settings on CO2 levels during nasal intermittent positive pressure ventilation (NIPPV) in premature infants. J Perinatol. 2023 Mar;43(3):305-310. doi: 10.1038/s41372-023-01614-7. Epub 2023 Feb 9.

  PMID: 36759706 DERIVED

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, NICU

Model Details: 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 Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: April 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 22, 2022

Record last verified: 2022-09

Locations

IL (1)