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

Withdrawn

• Conditions: Respiratory Failure (Pediatric Patients)

• Registration Number: NCT04895332
• Lead Sponsor: Charite University, Berlin, Germany

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)

Study Timeline

• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-20
• Study Start: 2021-06-21
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BPOI (Berlin Pediatric Oxygenation Index)	01.01.2017-28.02.2021	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.

Secondary Outcome Measures

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