Back to resultsInfluence of Respiratory Rate Settings on CO2 Levels During Nasal Intermittent Positive Pressure Ventilation (NIPPV).
Primary Purpose
Ventilator Lung; Newborn
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
nasal intermittent positive pressure ventilation (NIPPV).
Sponsored by
About this trial
This is an interventional treatment trial for Ventilator Lung; Newborn
Eligibility Criteria
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.
Sites / Locations
- Rambam Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
30 breaths per minutes
10 breaths per minute
Arm Description
Using NIPPV with rate of 30 for 1 hour. Measuring trans cutaneous CO2
Using NIPPV with rate of 10 for 1 hour. Measuring trans cutaneous CO2
Outcomes
Primary Outcome Measures
Trans cutaneous CO2 (TCCO2)
Trans cutaneous CO2
Secondary Outcome Measures
Full Information
NCT ID
NCT04836689
First Posted
April 6, 2021
Last Updated
September 20, 2022
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT04836689
Brief Title
Influence of Respiratory Rate Settings on CO2 Levels During Nasal Intermittent Positive Pressure Ventilation (NIPPV).
Official Title
Influence of Respiratory Rate Settings on CO2 Levels During Nasal Intermittent Positive Pressure Ventilation (NIPPV).
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Lung; Newborn
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
30 breaths per minutes
Arm Type
Other
Arm Description
Using NIPPV with rate of 30 for 1 hour. Measuring trans cutaneous CO2
Arm Title
10 breaths per minute
Arm Type
Other
Arm Description
Using NIPPV with rate of 10 for 1 hour. Measuring trans cutaneous CO2
Intervention Type
Device
Intervention Name(s)
nasal intermittent positive pressure ventilation (NIPPV).
Intervention Description
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 Outcome Measure Information:
Title
Trans cutaneous CO2 (TCCO2)
Description
Trans cutaneous CO2
Time Frame
During the 3 hours of the study
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Influence of Respiratory Rate Settings on CO2 Levels During Nasal Intermittent Positive Pressure Ventilation (NIPPV).
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