Menu
Recruiting NCT05459116

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

No phase Interventional Respiratory Muscles Respiration, Artificial Respiratory Function Tests

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placement of nasogastric balloon.
Who it may be relevant to
Registry conditions: Respiratory Muscles, Respiration, Artificial, Respiratory Function Tests. Basic parameters: from 29 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Placement of nasogastric balloon
    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

Primary outcome measures

  • Tidal esophageal pressure swing (∆Pes) - D1 [Time frame: ∆Pes (average over 1 minute recording) at day 1 of mechanical ventilation]
  • Tidal esophageal pressure swing (∆Pes) - D2 [Time frame: ∆Pes (average over 1 minute recording) at day 2 of mechanical ventilation]
  • Tidal esophageal pressure swing (∆Pes) - D3 [Time frame: ∆Pes (average over 1 minute recording) at day 3 of mechanical ventilation]
  • Tidal esophageal pressure swing (∆Pes) - D4 [Time frame: ∆Pes (average over 1 minute recording) at day 4 of mechanical ventilation]
  • Tidal esophageal pressure swing (∆Pes) - D5 [Time frame: ∆Pes (average over 1 minute recording) at day 5 of mechanical ventilation]
  • Tidal esophageal pressure swing (∆Pes) - D6 [Time frame: ∆Pes (average over 1 minute recording) at day 6 of mechanical ventilation]
  • Tidal esophageal pressure swing (∆Pes) - D7 [Time frame: ∆Pes (average over 1 minute recording) at day 7 of mechanical ventilation]
  • Tidal esophageal pressure swing (∆Pes) - D8 [Time frame: ∆Pes (average over 1 minute recording) at day 8 of mechanical ventilation]
Secondary outcome measures (12)
  • Transpulmonary driving pressure (ΔPL) - D1 [Time frame: ∆PL (average over 1 minute recording) at day 1 of mechanical ventilation]
  • Transpulmonary driving pressure (ΔPL) - D2 [Time frame: ∆PL (average over 1 minute recording) at day 2 of mechanical ventilation]
  • Transpulmonary driving pressure (ΔPL) - D3 [Time frame: ∆PL (average over 1 minute recording) at day 3 of mechanical ventilation]
  • Transpulmonary driving pressure (ΔPL) - D4 [Time frame: ∆PL (average over 1 minute recording) at day 4 of mechanical ventilation]
  • Transpulmonary driving pressure (ΔPL) - D5 [Time frame: ∆PL (average over 1 minute recording) at day 5 of mechanical ventilation]
  • Transpulmonary driving pressure (ΔPL) - D6 [Time frame: ∆PL (average over 1 minute recording) at day 6 of mechanical ventilation]
  • Transpulmonary driving pressure (ΔPL) - D7 [Time frame: ∆PL (average over 1 minute recording) at day 7 of mechanical ventilation]
  • Transpulmonary driving pressure (ΔPL) - D8 [Time frame: ∆PL (average over 1 minute recording) at day 8 of mechanical ventilation]
  • Occlusion pressure (P0.1) - D1 [Time frame: P0.1 (average of 3 breaths) at day 1 of mechanical ventilation]
  • Occlusion pressure (P0.1) - D2 [Time frame: P0.1 (average of 3 breaths) at day 2 of mechanical ventilation]
  • Occlusion pressure (P0.1) - D3 [Time frame: P0.1 (average of 3 breaths) at day 3 of mechanical ventilation]
  • Occlusion pressure (P0.1) - D4 [Time frame: P0.1 (average of 3 breaths) at day 4 of mechanical ventilation]

Eligibility criteria

Inclusion criteria

  • age > 28 days
  • weight > 3kg
  • requiring invasive mechanical ventilation
  • anticipated length of ventilation > 48h

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Belgium · 2 centers
  • Antwerp University Hospital (UZA) — Edegem
  • University Hospital Leuven (UZL) — Leuven
Canada · 1 center
  • The Hospital for Sick Children (SickKids) — Toronto

Identifiers

NCT: NCT05459116 · EDGE1712

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗