Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-01 @ 11:56 PM
Study NCT ID:
NCT04895332
Status:
WITHDRAWN
Last Update Posted:
2024-01-18
First Post:
2021-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BPOI (Berlin Pediatric Oxygenation Index) - A New Predictor for Imminent Failure of HFNC in Children Avoiding Delayed NIV or Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Due to pandemia', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-16', 'studyFirstSubmitDate': '2021-05-17', 'studyFirstSubmitQcDate': '2021-05-17', 'lastUpdatePostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BPOI (Berlin Pediatric Oxygenation Index)', 'timeFrame': '01.01.2017-28.02.2021', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': '01.01.2017-28.02.2021', 'description': 'Measurement of heart rate at given time points'}, {'measure': 'Respiratory rate', 'timeFrame': '01.01.2017-28.02.2021', 'description': 'Measurement of respiratory rate at given time points'}, {'measure': 'Blood pressure (mean arterial pressure, MAP)', 'timeFrame': '01.01.2017-28.02.2021', 'description': 'Measurement of blood pressure at given time points'}, {'measure': 'Intensive care unit length of stay', 'timeFrame': '01.01.2017-28.02.2021', 'description': 'Time period until the patient is either deferred to another non-ICU or until end of treatment period/death'}, {'measure': 'High-flow nasal cannula therapy failure', 'timeFrame': '01.01.2017-28.02.2021', 'description': 'Count of days until the respiratory therapy is escalated to non-invasive ventilation after the cut-off value for the BPOI has been reached.'}, {'measure': 'Need for intubation', 'timeFrame': '01.01.2017-28.02.2021', 'description': 'High-flow nasal cannula (HFNC) or non-invasively ventilation (NIV failure)'}, {'measure': 'Need for mechanical ventilation', 'timeFrame': '01.01.2017-28.02.2021', 'description': 'Need for assisted or controlled ventilation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Failure (Pediatric Patients)']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "High-flow nasal cannula therapy is a broadly used instrument of respiratory support in pediatric and adult patients with respiratory failure.\n\nFor 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.\n\nThis index however is not applicable in the pediatric population because the physiological values of respiratory rate vary greatly across different ages.\n\nThus, 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:\n\nBPOI = (SpO2 \\* kg) / (Flow \\* FiO2)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '28 Days', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric Patients with respiratory failure and High-flow nasal cannula therapy (HFNC).\n\nApproximately 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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with respiratory failure and indication für High-flow nasal cannula therapy\n* Patients aged between 4 1/7 weeks and 18 years\n* 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\n\nExclusion Criteria:\n\n* Patients aged between 1 and 27 days (neonatal period)\n* Patients with congenital cyanotic heart defects\n* Patients after or in the course of haematopoetic stem cell transplantation\n* Patients with ambulatory respiratory support'}, 'identificationModule': {'nctId': 'NCT04895332', 'briefTitle': 'BPOI (Berlin Pediatric Oxygenation Index) - A New Predictor for Imminent Failure of HFNC in Children Avoiding Delayed NIV or Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'BPOI (Berlin Pediatric Oxygenation Index) - A New Predictor for Imminent Failure of HFNC in Children Avoiding Delayed NIV or Intubation', 'orgStudyIdInfo': {'id': 'BPOI'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Claudia Spies, MD, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK)', 'investigatorFullName': 'Claudia Spies', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}