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

Sponsor
Rambam Health Care Campus (Other)
Overall Status
Recruiting
CT.gov ID
NCT04836689
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: nasal intermittent positive pressure ventilation (NIPPV).
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention 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 rateInfants 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)
Primary Purpose:
Treatment
Official Title:
Influence of Respiratory Rate Settings on CO2 Levels During Nasal Intermittent Positive Pressure Ventilation (NIPPV).
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: 30 breaths per minutes

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

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.
Other: 10 breaths per minute

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

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.

Outcome Measures

Primary Outcome Measures

  1. Trans cutaneous CO2 (TCCO2) [During the 3 hours of the study]

    Trans cutaneous CO2

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 1 Month
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rambam Medical Center Haifa Israel 31096

Sponsors and Collaborators

  • Rambam Health Care Campus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ori Hochwald , MD, Director, NICU, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT04836689
Other Study ID Numbers:
  • RMB-0490-20
First Posted:
Apr 8, 2021
Last Update Posted:
Apr 12, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Bronchopulmonary Dysplasia

Study Results

No Results Posted as of Apr 12, 2021