Functional Residual Capacity During Different Levels of High-flow in Preterm Infants (FUNK-FLOW)
Primary Purpose
Infant, Premature, Diseases, Respiratory Distress Syndrome
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
High Flow
Sponsored by
About this trial
This is an interventional other trial for Infant, Premature, Diseases focused on measuring Non-invasive respiratory support, HighFlow, continuous positive airway pressure, functional residual capacity
Eligibility Criteria
Inclusion Criteria:
- Written Informed Consent by one or both parents or legal guardians as documented by signature
- 30 - 35 weeks postmenstrual age
- Respiratory support with nCPAP PEEP 5mbar and FiO2 < 0.30
- > 72 hours old
Exclusion Criteria:
- Inability of the parents to understand the study concept or procedures due to cognitive or linguistic reasons
- Congenital malformations adversely affecting lung aeration or pulmonary perfusion (e.g. congenital heart or lung defects)
Sites / Locations
- Newborn Research, Department of Neonatology, University Hospital Zurich
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
High Flow
Arm Description
Standard HighFlow therapy after weaning from continuous positive airway pressure therapy will be applied on different flow levels. Starting with a flow level of 8l/min, the flow-rates will be changed every 30 minutes subsequently from 8-6-4-2-4-6-8 l/min. Meanwhile, data lung volume changes will be measured using electrical impedance tomography.
Outcomes
Primary Outcome Measures
Change in global end-expiratory lung impedance (EELI) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
Change in global EELI over time using electrical impedance tomography (EIT)
Secondary Outcome Measures
Change in mean respiratory rate (RR) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
Change in RR over time using electrical impedance tomography (EIT)
Change in regional end-expiratory lung impedance (EELI) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
Change in regional EELI over time using electrical impedance tomography (EIT)
Change in mean minute volume during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
Change in mean minute volume over time using electrical impedance tomography (EIT), (AU/kg/min)
Change in mean ventilation distribution during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
Change in mean ventilation distribution over time using electrical impedance tomography (EIT), (%, left/right and ventral/dorsal)
Change in mean silent spaces during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
Change in mean silent spaces over time using electrical impedance tomography (EIT), (%, dependent, non-dependent lung)
Change in mean tidal volume during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
Change in mean tidal volume over time using electrical impedance tomography (EIT), (AU/kg)
Change in number of apnoea that required stimulation during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
Change in number of apnoea over time
Change in heart rate during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
Change in heart rate over time
Change in oxygen saturation during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
Change in oxygen saturation over time, SpO2, %
Change in fraction of inspired oxygen during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
Change in fraction of inspired oxygen over time
Change in reaching 'failure criteria' to stop HighFlow therapy during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
Definition of failure criteria:
Respiratory rate > 100/min for at least 30 minutes during the intervention
Increase in FiO2 by ≥ 0.25 from baseline to maintain oxygen saturation level within physician-ordered parameters
> 2 apnoea requiring stimulation per 30-minute-intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05237622
Brief Title
Functional Residual Capacity During Different Levels of High-flow in Preterm Infants
Acronym
FUNK-FLOW
Official Title
The FUNK-FLOW Study - Functional Residual Capacity During Different Levels of High-flow in Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 19, 2022 (Actual)
Primary Completion Date
January 13, 2023 (Actual)
Study Completion Date
January 13, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
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
Although there is a widespread use of HighFlow therapy around the world, there is still uncertainty about the most appropriate initial HighFlow level after nasal continuous positive airway pressure therapy. Higher levels might produce excessive and harmful intra-alveolar pressures exceeding those reached during nasal continuous positive airway pressure therapy. Low levels may not generate sufficient distending pressures, which may result in a loss of functional residual capacity and an increased risk of respiratory failure. Therefore, the aim of this study is to assess the effect of different HighFlow levels on the functional residual capacity and to compare these findings to the functional residual capacity during nasal continuous positive airway pressure therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature, Diseases, Respiratory Distress Syndrome
Keywords
Non-invasive respiratory support, HighFlow, continuous positive airway pressure, functional residual capacity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Flow
Arm Type
Other
Arm Description
Standard HighFlow therapy after weaning from continuous positive airway pressure therapy will be applied on different flow levels. Starting with a flow level of 8l/min, the flow-rates will be changed every 30 minutes subsequently from 8-6-4-2-4-6-8 l/min. Meanwhile, data lung volume changes will be measured using electrical impedance tomography.
Intervention Type
Device
Intervention Name(s)
High Flow
Intervention Description
Standard HighFlow therapy after weaning from continuous positive airway pressure therapy will be applied on different flow levels. Starting with a flow level of 8l/min, the flow-rates will be changed every 30 minutes subsequently from 8-6-4-2-4-6-8 l/min. Meanwhile, data on lung volume changes will be measured using electrical impedance tomography.
Primary Outcome Measure Information:
Title
Change in global end-expiratory lung impedance (EELI) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
Description
Change in global EELI over time using electrical impedance tomography (EIT)
Time Frame
230-minute recording period per patient, 30 minutes on each HF level
Secondary Outcome Measure Information:
Title
Change in mean respiratory rate (RR) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
Description
Change in RR over time using electrical impedance tomography (EIT)
Time Frame
230-minute recording period per patient, 30 minutes on each HF level
Title
Change in regional end-expiratory lung impedance (EELI) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
Description
Change in regional EELI over time using electrical impedance tomography (EIT)
Time Frame
230-minute recording period per patient, 30 minutes on each HF level
Title
Change in mean minute volume during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
Description
Change in mean minute volume over time using electrical impedance tomography (EIT), (AU/kg/min)
Time Frame
230-minute recording period per patient, 30 minutes on each HF level
Title
Change in mean ventilation distribution during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
Description
Change in mean ventilation distribution over time using electrical impedance tomography (EIT), (%, left/right and ventral/dorsal)
Time Frame
230-minute recording period per patient, 30 minutes on each HF level
Title
Change in mean silent spaces during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
Description
Change in mean silent spaces over time using electrical impedance tomography (EIT), (%, dependent, non-dependent lung)
Time Frame
230-minute recording period per patient, 30 minutes on each HF level
Title
Change in mean tidal volume during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
Description
Change in mean tidal volume over time using electrical impedance tomography (EIT), (AU/kg)
Time Frame
230-minute recording period per patient, 30 minutes on each HF level
Title
Change in number of apnoea that required stimulation during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
Description
Change in number of apnoea over time
Time Frame
230-minute recording period per patient, 30 minutes on each HF level
Title
Change in heart rate during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
Description
Change in heart rate over time
Time Frame
230-minute recording period per patient, 30 minutes on each HF level
Title
Change in oxygen saturation during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
Description
Change in oxygen saturation over time, SpO2, %
Time Frame
230-minute recording period per patient, 30 minutes on each HF level
Title
Change in fraction of inspired oxygen during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
Description
Change in fraction of inspired oxygen over time
Time Frame
230-minute recording period per patient, 30 minutes on each HF level
Title
Change in reaching 'failure criteria' to stop HighFlow therapy during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
Description
Definition of failure criteria:
Respiratory rate > 100/min for at least 30 minutes during the intervention
Increase in FiO2 by ≥ 0.25 from baseline to maintain oxygen saturation level within physician-ordered parameters
> 2 apnoea requiring stimulation per 30-minute-intervention
Time Frame
230-minute recording period per patient, 30 minutes on each HF level
10. Eligibility
Sex
All
Minimum Age & Unit of Time
73 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written Informed Consent by one or both parents or legal guardians as documented by signature
30 - 35 weeks postmenstrual age
Respiratory support with nCPAP PEEP 5mbar and FiO2 < 0.30
> 72 hours old
Exclusion Criteria:
Inability of the parents to understand the study concept or procedures due to cognitive or linguistic reasons
Congenital malformations adversely affecting lung aeration or pulmonary perfusion (e.g. congenital heart or lung defects)
Facility Information:
Facility Name
Newborn Research, Department of Neonatology, University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
23260098
Citation
Collins CL, Holberton JR, Barfield C, Davis PG. A randomized controlled trial to compare heated humidified high-flow nasal cannulae with nasal continuous positive airway pressure postextubation in premature infants. J Pediatr. 2013 May;162(5):949-54.e1. doi: 10.1016/j.jpeds.2012.11.016. Epub 2012 Dec 20.
Results Reference
background
PubMed Identifier
27596161
Citation
Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.
Results Reference
background
PubMed Identifier
24561568
Citation
van der Burg PS, Miedema M, de Jongh FH, Frerichs I, van Kaam AH. Cross-sectional changes in lung volume measured by electrical impedance tomography are representative for the whole lung in ventilated preterm infants. Crit Care Med. 2014 Jun;42(6):1524-30. doi: 10.1097/CCM.0000000000000230.
Results Reference
background
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Functional Residual Capacity During Different Levels of High-flow in Preterm Infants
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