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NCT02762279: APPLE
Assessment of Esophageal Pressure Reliability to Estimate Pleural Pressure in Critically Ill Children
NA trial testing esophageal and pleural pressure measurement in Mechanical Ventilation in 12 participants. Completed in 1 October 2017.
1 October 2017
Quick facts
| Lead sponsor | St. Justine's Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 12 |
| Start date | 28 June 2016 |
| Primary completion | 1 October 2017 |
| Estimated completion | 1 October 2017 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- esophageal and pleural pressure measurement
Conditions studied
- Mechanical Ventilation — all drugs for Mechanical Ventilation →
Sponsor
St. Justine's Hospital
Who can join
Adults 1 Day to 18, any sex, with Mechanical Ventilation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background During ventilatory assistance, optimization of settings is critical to allow a personalized support and avoid over- or under-assistance. But little data are available in clinical practice to guide the adjustment of the support. In adults, esophageal pressure (PES) has been shown to be a reliable surrogate of pleural pressure (PPL) and clinical studies suggest that PES may be useful to guide the management of mechanical ventilation. In children, the PES measurement could have similar potential benefits, but beforehand the reliability of PES to estimate PPL needs to be assessed. Objective The primary objective of this study is to validate the reliability of PES directly monitored using a miniature catheter tip pressure transducer (Gaeltec® system) to estimate PPL, when compared to a gold standard, i.e the direct PPL measurement in situ. Method This is a prospective single center study. Children \<18 years old, hospitalized in the pediatric intensive care unit, requiring invasive ventilation and with at least one chest tube will be included. Protocol A pressure transducer will be connected to the existing chest-tube and PES (measured by Gaeltec® and feeding tube), PPL, PAW, respiratory volume and flow will be simultaneously recorded. Expected results We expect that the PES-based methods will provide an accurate estimation of PPL. Once this tool validated, PES could be helpful to optimize mechanical ventilation in children, and further interventional trials would be warranted to evaluate if its use could allow a reduction of the ventilation support duration.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02762279
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Mechanical Ventilation
Currently open trials in the same condition.
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- NCT06994442 — Optimizing Pain Treatment in Children On Mechanical Ventilation · Phase 3 · recruiting
- NCT07193719 — Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children · Phase 1, PHASE2 · recruiting
Other St. Justine's Hospital trials
Trials by the same sponsor.
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- NCT06192368 — Virtual Reality Program to Reduce Stress in Neonatal Nurses · NA · completed
- NCT06217510 — Pilot Project on the Automatic Design and 3D Printing of Adolescent Idiopathic Scoliosis Braces (Phase 1) · NA · unknown
- NCT06173102 — Cranial Orthosis Therapy for Plagiocephaly: an RCT Pilot Study Comparing Cranial Orthosis to the Natural Course · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02762279 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by St. Justine's Hospital
- Last refreshed: 23 August 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02762279.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing