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

NCT04895332 | Withdrawn

• 1 other identifier: BPOI
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Failure (Pediatric Patients)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Heart rate

  01.01.2017-28.02.2021

• Respiratory rate

  01.01.2017-28.02.2021

• Blood pressure (mean arterial pressure, MAP)

  01.01.2017-28.02.2021

• Intensive care unit length of stay

  01.01.2017-28.02.2021

• High-flow nasal cannula therapy failure

  01.01.2017-28.02.2021

Eligibility Criteria

• Age: 28 Days - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Claudia Spies, MD, Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK)

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 20, 2021
• Study Start: June 21, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share