Ignite Creation Date:
2024-05-06 @ 8:34 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02762279
Status:
COMPLETED
Last Update Posted:
2018-08-23
First Post:
2016-04-28
Brief Title:
Assessment of Esophageal Pressure Reliability to Estimate Pleural Pressure in Critically Ill Children
Sponsor:
St Justines Hospital
Organization:
St Justines Hospital
Study Overview
Official Title:
Assessment of Esophageal Pressure Reliability to Estimate Pleural Pressure in Critically Ill Children
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APPLE
Brief Summary:
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 ie 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
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 ie 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None