RecruitingNot ApplicableNCT05459116

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


Sponsor

University Hospital, Antwerp

Enrollment

150 participants

Start Date

Sep 21, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 29 Days

Plain Language Summary

Simplified for easier understanding

This study focuses on improving how doctors monitor and protect the lungs and breathing muscle (diaphragm) in patients who need a breathing machine (mechanical ventilator). When patients are on a ventilator, too much or too little pressure can injure the lungs and weaken the diaphragm. This study tests new tools to visualize breathing effort and lung mechanics in real time, helping doctors fine-tune ventilator settings. You may be eligible if: - You are older than 28 days of age - You weigh more than 3 kilograms (about 6.6 lbs) - You require invasive mechanical ventilation (a breathing tube connected to a machine) - You are expected to need ventilation for more than 48 hours You may NOT be eligible if: - Consent is refused - You have been on a ventilator within the past 2 weeks before joining the study - You have a known abnormality in the shape of your diaphragm (including congenital diaphragmatic hernia) - There is a medical reason you cannot have a special measurement tube placed through the nose into the esophagus Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEPlacement 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.


Locations(3)

Antwerp University Hospital (UZA)

Edegem, Antwerp, Belgium

University Hospital Leuven (UZL)

Leuven, Belgium

The Hospital for Sick Children (SickKids)

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05459116


Related Trials