Study Stopped
Due to pandemia
Due to pandemia
Sponsor study identifier
observational
0
0 countries
N/A
Study Start
June 21, 2021
Actual (reported)Primary Completion
December 31, 2021
Actual (reported)Study Completion
December 31, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 17, 2021
Actual (reported)May 20, 2021
Actual (reported)June 21, 2021
Actual (reported)December 31, 2021
Actual (reported)December 31, 2021
Actual (reported)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
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
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.
Claudia Spies, MD, Prof.
Charite University, Berlin, Germany
0 participants (actual enrollment reported by the registry).
First Submitted
May 17, 2021
First Posted
May 20, 2021
Study Start
June 21, 2021
Actual (reported)AI-Guided Mechanical Ventilation in Children: A Randomized Controlled Trial
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2021
Actual (reported)Study Completion
December 31, 2021
Actual (reported)Last Updated
January 18, 2024
Record last verified: 2024-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: