About this trial
This is a multicentre prospective cohort trial in adult and pediatric ICU patients. The investigators will measure the effect of a patient's inspiratory effort during mechanical ventilation on the lungs and diaphragm. The investigators will daily (for a maximum of 8 days) measure esophageal pressures with a balloon catheter to quantify inspiratory effort and respiratory muscle function, and perform daily ultrasound measurements of the diaphragm and the lungs. The investigators hypothesize that a small inspiratory effort will result in the preservation of diaphragm function and have no adverse effect on lung function.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age > 28 days
weight > 3kg
requiring invasive mechanical ventilation
anticipated length of ventilation > 48h
Disqualifiers
refusal of consent
mechanical ventilation ≤ 2 weeks before inclusion
known anatomical malformation of the diaphragm (including congenital diaphragmatic hernia)
contra-indication to the placement of a naso-gastric esophageal balloon catheter
Trial design
Single group
Treatments tested in this trial
Placement of nasogastric balloon
DeviceA nasogastric balloon catheter will be inserted after inclusion. This will be a NutriVent (Sidam S.R.L., Mirandola, Italy) for patients \>40kg, and a SmartCath Esophageal pressure catheter (Vyaire/Carefusion) for patients \<40kg. This placement is similar to a standard nasogastric tube placement, which is a common procedure in an ICU. Potential minor side effects include a nosebleed, sore throat and erosion of the nose where the tube is anchored. All patients will receive this intervention. When the esophageal catheter becomes displaced or is accidentally removed during the study period, it will be replaced.
Treatment groups
Trial outcomes
Primary outcomes
Tidal esophageal pressure swing (∆Pes) - D1
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Tidal esophageal pressure swing (∆Pes) - D2
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Tidal esophageal pressure swing (∆Pes) - D3
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Tidal esophageal pressure swing (∆Pes) - D4
Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Secondary outcomes
Transpulmonary driving pressure (ΔPL) - D1
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Transpulmonary driving pressure (ΔPL) - D2
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Transpulmonary driving pressure (ΔPL) - D3
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Transpulmonary driving pressure (ΔPL) - D4
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Sponsors and contacts
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University Hospital, Antwerp
Lead sponsor
Research Foundation Flanders
Collaborator
Universitaire Ziekenhuizen KU Leuven
Collaborator
The Hospital for Sick Children
Collaborator
University of Toronto
Collaborator
Universiteit Antwerpen
Collaborator
KU Leuven
Collaborator