An observational study in Respiratory Failure (Pediatric Patients), sponsored by Charite University, Berlin, Germany. Withdrawn. Open to participants aged 28 Days to 17 Years. Per ClinicalTrials.gov, last updated 2024-01-18.
Sponsored by Charite University, Berlin, Germany · Observational
The investigators developed an index that integrates different flow-settings in High-flow nasal cannula (HFNC) therapy with non-invasively measured clinical parameters of oxygenation in pediatric patients. This observational study is designed to evaluate this index and to determine a cut-off value for imminent HFNC failure.
High-flow nasal cannula therapy is a broadly used instrument of respiratory support in pediatric and adult patients with respiratory failure.
For adult patients with pneumonia and respiratory failure, there is a validated index (ROX; ratio SpO2/FiO2) which helps to identify those at risks for the need of intubation.
This index however is not applicable in the pediatric population because the physiological values of respiratory rate vary greatly across different ages.
Thus, based on the particularities of pediatric patients the investigators developed an index that integrates different flow-settings in HFNC therapy with non-invasively measured clinical parameters of oxygenation. The BPOI is defined as the ratio of the product of the peripherally measured oxygen saturation and the patient's body weight divided by the product of HFNC flow and the fraction of inspired oxygen:
BPOI = (SpO2 * kg) / (Flow * FiO2)
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
Browse Respiratory Insufficiency studies →Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.
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Pediatric Patients with respiratory failure and High-flow nasal cannula therapy (HFNC).
Approximately 220 patients will be enrolled in the observational study. Their data collected during their entire hospital stay which is saved on the clinical data processing system will be evaluated to reproduce the BPOI (BPOI = (SpO2 * kg) / (Flow * FiO2) ) We will compare the indices of patients who failed and those who were successfully treated with HFNC therapy. Failure is defined by the need for non-invasive or invasive mechanical ventilation.
Exclusion Criteria:
BPOI (Berlin Pediatric Oxygenation Index)
Evaluation of a certain cut-off value for the BPOI (Berlin Pediatric Oxygenation Index) that predicts imminent failure of high-flow nasal cannula (HFNC) therapy in paediatric patients.
Time frame: 01.01.2017-28.02.2021
Heart rate
Measurement of heart rate at given time points
Time frame: 01.01.2017-28.02.2021
Respiratory rate
Measurement of respiratory rate at given time points
Time frame: 01.01.2017-28.02.2021
Blood pressure (mean arterial pressure, MAP)
Measurement of blood pressure at given time points
Time frame: 01.01.2017-28.02.2021
Intensive care unit length of stay
Time period until the patient is either deferred to another non-ICU or until end of treatment period/death
Time frame: 01.01.2017-28.02.2021
High-flow nasal cannula therapy failure
Count of days until the respiratory therapy is escalated to non-invasive ventilation after the cut-off value for the BPOI has been reached.
Time frame: 01.01.2017-28.02.2021
Need for intubation
High-flow nasal cannula (HFNC) or non-invasively ventilation (NIV failure)
Time frame: 01.01.2017-28.02.2021
Need for mechanical ventilation
Need for assisted or controlled ventilation
Time frame: 01.01.2017-28.02.2021
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany