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

Antwerp University Hospital (UZA)

Status: Enrolling

Conditions: Respiratory Muscles; Respiration, Artificial; Respiratory Function Tests

Treatments: Device: Placement of nasogastric balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT05459116

EDGE1712

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 29+ days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Overall group

Experimental group

Description:

Placement of a nasogastric balloon

Treatment:

Device: Placement of nasogastric balloon