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BPOI (Berlin Pediatric Oxygenation Index) - A New Predictor for Imminent Failure of HFNC in Children Avoiding Delayed NIV or Intubation

BPOI (Berlin Pediatric Oxygenation Index) - A New Predictor for Imminent Failure of HFNC in Children Avoiding Delayed NIV or Intubation

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04895332
Enrollment
0
Registered
2021-05-20
Start date
2021-06-21
Completion date
2021-12-31
Last updated
2024-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure (Pediatric Patients)

Brief summary

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.

Detailed description

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)

Interventions

None listed

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
28 Days to 17 Years
Healthy volunteers
No

Inclusion criteria

* Patients with respiratory failure and indication für High-flow nasal cannula therapy * Patients aged between 4 1/7 weeks and 18 years * Patients who were treated between 01/01/2017 and 28/02/2021 in the Department of Pediatric Pulmonology, Immunology and Intensive Care Medicine at Campus Virchow- Klinikum, Charité - Universitätsmedizin Berlin

Exclusion criteria

* Patients aged between 1 and 27 days (neonatal period) * Patients with congenital cyanotic heart defects * Patients after or in the course of haematopoetic stem cell transplantation * Patients with ambulatory respiratory support

Design outcomes

Primary

MeasureTime frameDescription
BPOI (Berlin Pediatric Oxygenation Index)01.01.2017-28.02.2021Evaluation 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.

Secondary

MeasureTime frameDescription
Heart rate01.01.2017-28.02.2021Measurement of heart rate at given time points
Blood pressure (mean arterial pressure, MAP)01.01.2017-28.02.2021Measurement of blood pressure at given time points
Intensive care unit length of stay01.01.2017-28.02.2021Time period until the patient is either deferred to another non-ICU or until end of treatment period/death
Respiratory rate01.01.2017-28.02.2021Measurement of respiratory rate at given time points
Need for intubation01.01.2017-28.02.2021High-flow nasal cannula (HFNC) or non-invasively ventilation (NIV failure)
Need for mechanical ventilation01.01.2017-28.02.2021Need for assisted or controlled ventilation
High-flow nasal cannula therapy failure01.01.2017-28.02.2021Count of days until the respiratory therapy is escalated to non-invasive ventilation after the cut-off value for the BPOI has been reached.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026