An interventional study of High Flow in Infant, Premature, Diseases and Respiratory Distress Syndrome, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 73 Hours and older. Per ClinicalTrials.gov, last updated 2024-07-09.
Sponsored by University of Zurich · Not applicable, Interventional, and Other
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.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
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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.
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)
Time frame: 230-minute recording period per patient, 30 minutes on each HF level
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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, %
Time frame: 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
Time frame: 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
Time frame: 230-minute recording period per patient, 30 minutes on each HF level
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
University of Zurich