Visualization of Inspiratory Effort and Respiratory Mechanics to Promote Lung- and Diaphragm Protective Ventilation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age29+
SponsorUniversity Hospital, Antwerp

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Placement of nasogastric balloon

    Device

    A 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

150 Participants
are divided into 1 treatment group
Group A: Overall groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
∆Pes (average over 1 minute recording) at day 1 of mechanical ventilation
2

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.

Time frame
∆Pes (average over 1 minute recording) at day 2 of mechanical ventilation
3

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.

Time frame
∆Pes (average over 1 minute recording) at day 3 of mechanical ventilation
4

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.

Time frame
∆Pes (average over 1 minute recording) at day 4 of mechanical ventilation

Secondary outcomes

1

Transpulmonary driving pressure (ΔPL) - D1

∆PL is calculated as change in airway pressure minus change in esophageal pressure

Time frame
∆PL (average over 1 minute recording) at day 1 of mechanical ventilation
2

Transpulmonary driving pressure (ΔPL) - D2

∆PL is calculated as change in airway pressure minus change in esophageal pressure

Time frame
∆PL (average over 1 minute recording) at day 2 of mechanical ventilation
3

Transpulmonary driving pressure (ΔPL) - D3

∆PL is calculated as change in airway pressure minus change in esophageal pressure

Time frame
∆PL (average over 1 minute recording) at day 3 of mechanical ventilation
4

Transpulmonary driving pressure (ΔPL) - D4

∆PL is calculated as change in airway pressure minus change in esophageal pressure

Time frame
∆PL (average over 1 minute recording) at day 4 of mechanical ventilation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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