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This observational study aims to determine whether an AI-assisted decision support system can improve clinical outcomes for mechanically ventilated pediatric patients (aged 1 month to 18 years) in the PICU, compared to standard care provided by medical staff. The primary question addressed is: Do patients whose ventilator parameter optimization decisions are guided by AI assistance achieve a greater number of ventilator-free days within 28 days than those managed by medical staff? By utilizing clinical data collected following tracheal intubation to generate AI-driven recommendations-and comparing these against the actual adjustments made by physicians-this study seeks to assess whether the AI-assisted decision support system can effectively improve clinical outcomes for mechanically ventilated patients in the PICU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI-Assisted Ventilator Parameter Optimization in Pediatric ICU | Clinical data from key time points following tracheal intubation in each pediatric patient were input into an AI system to generate recommendations. These recommendations were then compared against the actual adjustments made by physicians, enabling a counterfactual assessment to determine whether-had the AI's suggestions been adopted-the number of ventilator-free days within a 28-day period would have been superior. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of ventilator-free days within 28 days | Days survived and free from invasive ventilation | From the start of tracheal intubation until 28 days after tracheal intubation. |
| Measure | Description | Time Frame |
|---|---|---|
| mortality rate | All-cause mortality at 28 and 90 days following tracheal intubation | 28 and 90 days after the initiation of tracheal intubation |
| Mechanical Ventilation-Related Complications | Cumulative duration of mechanical ventilation, reintubation rate (within 48 hours of extubation), ventilator-associated pneumonia (VAP), barotrauma. |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients aged 1 month to 18 years admitted to the Pediatric Intensive Care Unit (PICU) of the Second Affiliated Hospital of Wenzhou Medical University and Yuying Children's Hospital, who are receiving mechanical ventilation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Wenzhou Medical University and Yuying Children's Hospital | Wenzhou | Zhejiang | 325000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29539284 | Result | Char DS, Shah NH, Magnus D. Implementing Machine Learning in Health Care - Addressing Ethical Challenges. N Engl J Med. 2018 Mar 15;378(11):981-983. doi: 10.1056/NEJMp1714229. No abstract available. | |
| 31965266 | Result | Fleuren LM, Klausch TLT, Zwager CL, Schoonmade LJ, Guo T, Roggeveen LF, Swart EL, Girbes ARJ, Thoral P, Ercole A, Hoogendoorn M, Elbers PWG. Machine learning for the prediction of sepsis: a systematic review and meta-analysis of diagnostic test accuracy. Intensive Care Med. 2020 Mar;46(3):383-400. doi: 10.1007/s00134-019-05872-y. Epub 2020 Jan 21. |
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Individual participant data will not be shared, the study's ethical approvals and consent agreements do not permit public data sharing. Access may be considered upon reasonable request to the corresponding author, subject to institutional review and data use agreements to ensure patient privacy and compliance with regulations.
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| From the start of tracheal intubation to Day 28 |
| Length of Hospital Stay | PICU Length of Stay, Total Hospital Length of Stay | The duration from the time of admission to discharge for pediatric patients-up to a maximum of three months. |
| Artificial Intelligence System Evaluation | Physician Adoption Rates and Outcomes of Cases Involving Discrepancies Between AI Recommendations and Physician Decisions | From the start of tracheal intubation to Day 28 |
| Health Economics | PICU Hospitalization Costs | The duration from the time of admission to discharge for pediatric patients-up to a maximum of three months. |
| 27620287 | Result | Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12. |
| 25466337 | Result | Pirracchio R, Petersen ML, Carone M, Rigon MR, Chevret S, van der Laan MJ. Mortality prediction in intensive care units with the Super ICU Learner Algorithm (SICULA): a population-based study. Lancet Respir Med. 2015 Jan;3(1):42-52. doi: 10.1016/S2213-2600(14)70239-5. Epub 2014 Nov 24. |
| 28657867 | Result | Chen JH, Asch SM. Machine Learning and Prediction in Medicine - Beyond the Peak of Inflated Expectations. N Engl J Med. 2017 Jun 29;376(26):2507-2509. doi: 10.1056/NEJMp1702071. No abstract available. |
| 30349085 | Result | Komorowski M, Celi LA, Badawi O, Gordon AC, Faisal AA. The Artificial Intelligence Clinician learns optimal treatment strategies for sepsis in intensive care. Nat Med. 2018 Nov;24(11):1716-1720. doi: 10.1038/s41591-018-0213-5. Epub 2018 Oct 22. |
| 10793162 | Result | Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801. |
| 30617335 | Result | Esteva A, Robicquet A, Ramsundar B, Kuleshov V, DePristo M, Chou K, Cui C, Corrado G, Thrun S, Dean J. A guide to deep learning in healthcare. Nat Med. 2019 Jan;25(1):24-29. doi: 10.1038/s41591-018-0316-z. Epub 2019 Jan 7. |
| 30617339 | Result | Topol EJ. High-performance medicine: the convergence of human and artificial intelligence. Nat Med. 2019 Jan;25(1):44-56. doi: 10.1038/s41591-018-0300-7. Epub 2019 Jan 7. |