Infant, Premature, Diseases, Respiratory Distress Syndrome
Conditions
Keywords
Non-invasive respiratory support, HighFlow, continuous positive airway pressure, functional residual capacity
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.
Interventions
DEVICEHigh 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.
Sponsors
University of Zurich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
73 Hours to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in global end-expiratory lung impedance (EELI) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF) | 230-minute recording period per patient, 30 minutes on each HF level | Change in global EELI over time using electrical impedance tomography (EIT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in regional end-expiratory lung impedance (EELI) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF) | 230-minute recording period per patient, 30 minutes on each HF level | Change in regional EELI over time using electrical impedance tomography (EIT) |
| Change in mean minute volume during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF) | 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) |
| Change in mean ventilation distribution during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF) | 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) |
| Change in mean silent spaces during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF) | 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) |
| Change in mean tidal volume during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF) | 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) |
| Change in mean respiratory rate (RR) during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF) | 230-minute recording period per patient, 30 minutes on each HF level | Change in RR over time using electrical impedance tomography (EIT) |
| Change in heart rate during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF) | 230-minute recording period per patient, 30 minutes on each HF level | Change in heart rate over time |
| Change in oxygen saturation during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF) | 230-minute recording period per patient, 30 minutes on each HF level | Change in oxygen saturation over time, SpO2, % |
| Change in fraction of inspired oxygen during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF) | 230-minute recording period per patient, 30 minutes on each HF level | Change in fraction of inspired oxygen over time |
| Change in reaching 'failure criteria' to stop HighFlow therapy during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF) | 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 |
| Change in number of apnoea that required stimulation during the weaning procedure from nasal continuous positive airway pressure (nCPAP) to HighFlow (HF) | 230-minute recording period per patient, 30 minutes on each HF level | Change in number of apnoea over time |
Countries
Switzerland
Outcome results
None listed