Respiratory Failure (Pediatric Patients)NCT04895332
BPOI (Berlin Pediatric Oxygenation Index) - A New Predictor for Imminent Failure of HFNC in Children Avoiding Delayed NIV or Intubation
An observational study of Respiratory Failure (Pediatric Patients), run by Charite University, Berlin, Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 days to 17 years
- Conditions the study is for
- Respiratory Failure (Pediatric Patients)
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 21 Jun 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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)
- Conditions
- Respiratory Failure (Pediatric Patients)
- Medical subject headings
- Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 01.01.2017-28.02.2021
Secondary outcomes (7)
Heart rate
Measurement of heart rate at given time points
Measured: 01.01.2017-28.02.2021
Respiratory rate
Measurement of respiratory rate at given time points
Measured: 01.01.2017-28.02.2021
Blood pressure (mean arterial pressure, MAP)
Measurement of blood pressure at given time points
Measured: 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
Measured: 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.
Measured: 01.01.2017-28.02.2021
Need for intubation
High-flow nasal cannula (HFNC) or non-invasively ventilation (NIV failure)
Measured: 01.01.2017-28.02.2021
Need for mechanical ventilation
Need for assisted or controlled ventilation
Measured: 01.01.2017-28.02.2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start21 Jun 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: Due to pandemia
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Failure (Pediatric Patients)Studies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895332
- Sponsor's protocol ID
- BPOI
- Status last verified
- Jan 2024
- First submitted
- 17 May 2021
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BPOI (Berlin Pediatric Oxygenation Index) - A New Predictor for Imminent Failure of HFNC in Children Avoiding Delayed NIV or Intubation
- ClinicalTrials.gov ID
- NCT04895332
- Acronym / sponsor ID
- BPOI
- Conditions
- Respiratory Failure (Pediatric Patients)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to pandemia
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 28 days to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BPOI (Berlin Pediatric Oxygenation Index)
Time frame: 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.
7 secondary outcomes
Heart rate
Time frame: 01.01.2017-28.02.2021
Respiratory rate
Time frame: 01.01.2017-28.02.2021
Blood pressure (mean arterial pressure, MAP)
Time frame: 01.01.2017-28.02.2021
Intensive care unit length of stay
Time frame: 01.01.2017-28.02.2021
High-flow nasal cannula therapy failure
Time frame: 01.01.2017-28.02.2021
Need for intubation
Time frame: 01.01.2017-28.02.2021
Need for mechanical ventilation
Time frame: 01.01.2017-28.02.2021
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure (Pediatric Patients), run by Charite University, Berlin, Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BPOI (Berlin Pediatric Oxygenation Index) (time frame: 01.01.2017-28.02.2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.