Functional Residual Capacity During Different Levels of High-flow in Preterm Infants (FUNK-FLOW)

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

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.

Study Overview

• Status: Completed
• Conditions: Infant, Premature, Diseases; Respiratory Distress Syndrome
• Intervention / Treatment: Device: High Flow

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Newborn Research, Department of Neonatology, University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 days and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 lung volume changes will be measured using electrical impedance tomography.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Zurich

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2022
• Primary Completion (Actual): January 13, 2023
• Study Completion (Actual): January 13, 2023

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: continuous positive airway pressure; functional residual capacity; Non-invasive respiratory support; HighFlow
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: Lung volumes during HighFlow

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No