Functional Residual Capacity During Different Levels of High-flow in Preterm Infants

Respiratory Distress Syndrome Clinical Trial

— FUNK-FLOW  

Official title:

The FUNK-FLOW Study - Functional Residual Capacity During Different Levels of High-flow in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05237622
• Other study ID #: Lung volumes during HighFlow
• Status: Completed
• Phase: N/A
• Start date: February 19, 2022
• Est. completion date: January 13, 2023

Study information

• Verified date: March 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 13, 2023
• Est. primary completion date: January 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 73 Hours and older

Eligibility

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)

Related Conditions & MeSH terms

• Infant, Premature, Diseases
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• High Flow
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.

Locations

Country	Name	City	State
Switzerland	Newborn Research, Department of Neonatology, University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	230-minute recording period per patient, 30 minutes on each HF level
Secondary	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)	230-minute recording period per patient, 30 minutes on each HF level
Secondary	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)	230-minute recording period per patient, 30 minutes on each HF level
Secondary	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)	230-minute recording period per patient, 30 minutes on each HF level
Secondary	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)	230-minute recording period per patient, 30 minutes on each HF level
Secondary	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)	230-minute recording period per patient, 30 minutes on each HF level
Secondary	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)	230-minute recording period per patient, 30 minutes on each HF level
Secondary	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	230-minute recording period per patient, 30 minutes on each HF level
Secondary	Change in heart rate during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)	Change in heart rate over time	230-minute recording period per patient, 30 minutes on each HF level
Secondary	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, %	230-minute recording period per patient, 30 minutes on each HF level
Secondary	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	230-minute recording period per patient, 30 minutes on each HF level
Secondary	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	230-minute recording period per patient, 30 minutes on each HF level