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

NCT ID: NCT04895332

Last Updated: 2024-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-21

Study Completion Date

2021-12-31

Brief Summary

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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

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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)

Conditions

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Respiratory Failure (Pediatric Patients)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

28 Days

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Claudia Spies

Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudia Spies, MD, Prof.

Role: STUDY_DIRECTOR

Charite University, Berlin, Germany

Other Identifiers

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BPOI

Identifier Type: -

Identifier Source: org_study_id

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