Clinical trial NCT05237622: Functional Residual Capacity During Different Levels of High-flow in Preterm Infants
Official title: The FUNK-FLOW Study - Functional Residual Capacity During Different Levels of High-flow in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature, Diseases
Respiratory Distress Syndrome
Keywords: Non-invasive respiratory support
HighFlow
continuous positive airway pressure
functional residual capacity
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 20
Sex: ALL
Minimum age (years): 73
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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)

Primary outcomes:
measure: Change in global end-expiratory lung impedance (EELI) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
timeFrame: 230-minute recording period per patient, 30 minutes on each HF level
Secondary outcomes:
measure: Change in mean respiratory rate (RR) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
timeFrame: 230-minute recording period per patient, 30 minutes on each HF level
measure: Change in regional end-expiratory lung impedance (EELI) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
timeFrame: 230-minute recording period per patient, 30 minutes on each HF level
measure: Change in mean minute volume during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
timeFrame: 230-minute recording period per patient, 30 minutes on each HF level
measure: Change in mean ventilation distribution during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
timeFrame: 230-minute recording period per patient, 30 minutes on each HF level
measure: Change in mean silent spaces during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
timeFrame: 230-minute recording period per patient, 30 minutes on each HF level
measure: Change in mean tidal volume during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
timeFrame: 230-minute recording period per patient, 30 minutes on each HF level
measure: Change in number of apnoea that required stimulation during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
timeFrame: 230-minute recording period per patient, 30 minutes on each HF level
measure: Change in heart rate during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
timeFrame: 230-minute recording period per patient, 30 minutes on each HF level
measure: Change in oxygen saturation during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
timeFrame: 230-minute recording period per patient, 30 minutes on each HF level
measure: Change in fraction of inspired oxygen during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
timeFrame: 230-minute recording period per patient, 30 minutes on each HF level
measure: Change in reaching 'failure criteria' to stop HighFlow therapy during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)
timeFrame: 230-minute recording period per patient, 30 minutes on each HF level
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Newborn Research, Department of Neonatology, University Hospital Zurich
Study officials:
References:
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.
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.
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.