An interventional study of esophageal and pleural pressure measurement in Mechanical Ventilation, sponsored by St. Justine's Hospital. Completed at 1 site in Canada. Open to participants aged 1 Day to 18 Years. Per ClinicalTrials.gov, last updated 2018-08-23.
Sponsored by St. Justine's Hospital · Not applicable, Interventional, and Basic science
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.
St. Justine's Hospital is the lead sponsor of 156 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1. Patient baseline characteristics will be collected. 2. Specific nasogastric tube installation: a specific nasogastric tube equipped with pressure transducers (Gaeltec® probe) will be installed. 3. Connection of a pressure transducer to the existing chest-tube. 4. Simultaneous recordings of PES (Gaeltec®), PPL, PAW, respiratory volume and flow (5 minutes). 5. Removal of the Gaeltec® probe, and repositioning of the pre-existing nasogastric tube in the esophagus for PES measurement. 6. Simultaneous recordings of PES (feeding tube), PPL, PAW, respiratory volume and flow (5 minutes). 7. Repositioning of the nasogastric tube in the stomach, and disconnection of the different recording equipment.
Other: esophageal and pleural pressure measurement
Esophageal pressure will be monitored by a dedicated catheter and pleural pressure will be measured into the chest tube already in place
End-expiratory esophageal
End-expiratory PES and PL, calculated as the mean value of 10 consecutive breaths, during a stable period with no intervention or artifacts;
Time frame: Up to 2 hours from the beginning of the study
Pleural pressure
PPL, directly measured in the existing chest tubes, and calculated as the mean value of 10 consecutive breaths, during a stable period with no intervention or artifacts.
Time frame: Up to 2 hours from the beginning of the study
transpulmonary pressures
Time frame: Up to 2 hours from the beginning of the study
The Elastance-derived end-inspiratory transpulmonary pressure
The Elastance-derived end-inspiratory transpulmonary pressure, calculated as: PAW at end-inspiration x EL/ERS (EI and ERS being the respective elastances of the lung and the respiratory system, estimated on the esophageal and airway Pressure-Volume curves);
Time frame: Up to 2 hours from the beginning of the study
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.