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

NCT05459116 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-04-06

No results posted yet for this study

Summary

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.

Conditions

  • Respiratory Muscles
  • Respiration, Artificial
  • Respiratory Function Tests

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 the esophageal catheter becomes displaced or is accidentally removed during the study period, it will be replaced.

Sponsors & Collaborators

  • Research Foundation Flanders

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER

  • The Hospital for Sick Children

    collaborator OTHER

  • University of Toronto

    collaborator OTHER

  • Universiteit Antwerpen

    collaborator OTHER

  • KU Leuven

    collaborator OTHER

  • University Hospital, Antwerp

    lead OTHER

Principal Investigators

  • Tom Schepens, M.D., Ph.D. · PICU staff member

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
29 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-21
Primary Completion
2025-06-30
Completion
2025-12-01

Countries

  • Belgium
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05459116 on ClinicalTrials.gov