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

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Recruiting
CT.gov ID
NCT04895332
Collaborator
(none)
220
Enrollment
2
Locations
6.3
Anticipated Duration (Months)
110
Patients Per Site
17.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    220 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    BPOI (Berlin Pediatric Oxygenation Index) - A New Predictor for Imminent Failure of HFNC in Children Avoiding Delayed NIV or Intubation
    Actual Study Start Date :
    Jun 21, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2021
    Anticipated Study Completion Date :
    Dec 31, 2021

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Heart rate [01.01.2017-28.02.2021]

      Measurement of heart rate at given time points

    2. Respiratory rate [01.01.2017-28.02.2021]

      Measurement of respiratory rate at given time points

    3. Blood pressure (mean arterial pressure, MAP) [01.01.2017-28.02.2021]

      Measurement of blood pressure at given time points

    4. 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

    5. 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.

    6. Need for intubation [01.01.2017-28.02.2021]

      High-flow nasal cannula (HFNC) or non-invasively ventilation (NIV failure)

    7. Need for mechanical ventilation [01.01.2017-28.02.2021]

      Need for assisted or controlled ventilation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    28 Days to 17 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology and Operative Intensive Care Medicine CCM and CVK,Charité - University Medicine Berlin Berlin Germany 13353
    2 Department of Paediatrics with a focus on Pulmonology, Immunology and Intensive Care MedicineCharité - University Medicine Berlin Berlin Germany 13353

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Claudia Spies, Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT04895332
    Other Study ID Numbers:
    • BPOI
    First Posted:
    May 20, 2021
    Last Update Posted:
    Jun 23, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Respiratory Insufficiency

    Study Results

    No Results Posted as of Jun 23, 2021