Mechanical Ventilation
Conditions
Keywords
Mechanical ventilation, Children, Esophageal Pressure, Pleural Pressure
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, 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.
Interventions
OTHEResophageal 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
Sponsors
St. Justine's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children \<18 years old, hospitalized in the pediatric intensive care unit; * Requiring invasive ventilation for more than 4 hours according to the prescription of the attending physician; * With at least one chest tube.
Exclusion criteria
* Contraindications to the placement of a new nasogastric tube (e.g. bilateral phrenic paralysis, trauma or recent surgery in cervical or nasopharyngeal regions, severe coagulation disorder); * Hemodynamic instability, as defined by the treating team, and the absence of recent (\<4 hours) increase in the flow of dopamine, epinephrine, norepinephrine, or dobutamine; * Respiratory instability defined as a severe respiratory failure requiring FiO2 \> 60%, or PaCO2 \> 80 mmHg on blood gas in the last hour; * Persistent pleural effusion or pneumothorax despite the chest-tube; * Bronchopleural fistula; * Recent (\<12 hours) thoracic hemorrhage; * Delayed sternal closure at the time of study; * Significant pericardial effusion; * Absence of parental or tutor consent; * Patient for whom a limitation of life support treatments is discussed or decided.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| End-expiratory esophageal | Up to 2 hours from the beginning of the study | End-expiratory PES and PL, calculated as the mean value of 10 consecutive breaths, during a stable period with no intervention or artifacts; |
| Pleural pressure | Up to 2 hours from the beginning of the study | 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. |
| transpulmonary pressures | Up to 2 hours from the beginning of the study | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Elastance-derived end-inspiratory transpulmonary pressure | Up to 2 hours from the beginning of the study | 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); |
Countries
Canada
Outcome results
None listed