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

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.

Study Overview

• Status: Withdrawn
• Conditions: Respiratory Failure (Pediatric Patients)

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 Type: Observational

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Department of Anesthesiology and Operative Intensive Care Medicine CCM and CVK,Charité - University Medicine Berlin
    • Contact: Claudia Spies, MD Prof.; Phone Number: +4930450551001; Email: claudia.spies@charite.de
    • Sub-Investigator: David Grieser, MD
  • Berlin, Germany, 13353
    • Recruiting
    • Department of Paediatrics with a focus on Pulmonology, Immunology and Intensive Care MedicineCharité - University Medicine Berlin
    • Contact: Marcus Mall, MD, Prof.; Phone Number: +49 30 450 566131; Email: marcus.mall@charite.de
    • Principal Investigator: Marcus Mall, MD, Prof.
    • Sub-Investigator: Martin Wiehlpütz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 17 years (Child)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	01.01.2017-28.02.2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Measurement of heart rate at given time points	01.01.2017-28.02.2021
Respiratory rate	Measurement of respiratory rate at given time points	01.01.2017-28.02.2021
Blood pressure (mean arterial pressure, MAP)	Measurement of blood pressure at given time points	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	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.	01.01.2017-28.02.2021
Need for intubation	High-flow nasal cannula (HFNC) or non-invasively ventilation (NIV failure)	01.01.2017-28.02.2021
Need for mechanical ventilation	Need for assisted or controlled ventilation	01.01.2017-28.02.2021

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Study Director: Claudia Spies, MD, Prof., Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: BPOI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No