Clinical trial NCT04895332: BPOI (Berlin Pediatric Oxygenation Index) - A New Predictor for Imminent Failure of HFNC in Children Avoiding Delayed NIV or Intubation
Official title: BPOI (Berlin Pediatric Oxygenation Index) - A New Predictor for Imminent Failure of HFNC in Children Avoiding Delayed NIV or Intubation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Respiratory Failure (Pediatric Patients)
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 0
Sex: ALL
Minimum age (years): 28
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: BPOI (Berlin Pediatric Oxygenation Index)
timeFrame: 01.01.2017-28.02.2021
Secondary outcomes:
measure: Heart rate
timeFrame: 01.01.2017-28.02.2021
measure: Respiratory rate
timeFrame: 01.01.2017-28.02.2021
measure: Blood pressure (mean arterial pressure, MAP)
timeFrame: 01.01.2017-28.02.2021
measure: Intensive care unit length of stay
timeFrame: 01.01.2017-28.02.2021
measure: High-flow nasal cannula therapy failure
timeFrame: 01.01.2017-28.02.2021
measure: Need for intubation
timeFrame: 01.01.2017-28.02.2021
measure: Need for mechanical ventilation
timeFrame: 01.01.2017-28.02.2021
Other outcomes:
Locations:
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References: