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NCT Number: NCT05237622

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.

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Key information

Conditions

Infant, Premature, Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

73 hour and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Newborn Research, Department of Neonatology, University Hospital Zurich

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

High flow

Device

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 outcomes

  1. Change in global end-expiratory lung impedance (EELI) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

    Time frame: 230-minute recording period per patient, 30 minutes on each HF level

    Change in global EELI over time using electrical impedance tomography (EIT)

Secondary outcomes

  1. Change in mean respiratory rate (RR) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

    Time frame: 230-minute recording period per patient, 30 minutes on each HF level

    Change in RR over time using electrical impedance tomography (EIT)

  2. Change in regional end-expiratory lung impedance (EELI) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

    Time frame: 230-minute recording period per patient, 30 minutes on each HF level

    Change in regional EELI over time using electrical impedance tomography (EIT)

  3. Change in mean minute volume during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

    Time frame: 230-minute recording period per patient, 30 minutes on each HF level

    Change in mean minute volume over time using electrical impedance tomography (EIT), (AU/kg/min)

  4. Change in mean ventilation distribution during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

    Time frame: 230-minute recording period per patient, 30 minutes on each HF level

    Change in mean ventilation distribution over time using electrical impedance tomography (EIT), (%, left/right and ventral/dorsal)

  5. Change in mean silent spaces during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

    Time frame: 230-minute recording period per patient, 30 minutes on each HF level

    Change in mean silent spaces over time using electrical impedance tomography (EIT), (%, dependent, non-dependent lung)

  6. Change in mean tidal volume during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

    Time frame: 230-minute recording period per patient, 30 minutes on each HF level

    Change in mean tidal volume over time using electrical impedance tomography (EIT), (AU/kg)

  7. Change in number of apnoea that required stimulation during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

    Time frame: 230-minute recording period per patient, 30 minutes on each HF level

    Change in number of apnoea over time

  8. Change in heart rate during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

    Time frame: 230-minute recording period per patient, 30 minutes on each HF level

    Change in heart rate over time

  9. Change in oxygen saturation during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

    Time frame: 230-minute recording period per patient, 30 minutes on each HF level

    Change in oxygen saturation over time, SpO2, %

  10. Change in fraction of inspired oxygen during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

    Time frame: 230-minute recording period per patient, 30 minutes on each HF level

    Change in fraction of inspired oxygen over time

  11. Change in reaching 'failure criteria' to stop HighFlow therapy during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF)

    Time frame: 230-minute recording period per patient, 30 minutes on each HF level

    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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: FunkFlow

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 14, 2022
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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