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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-21

Study Completion Date

2025-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Respiratory Muscles Respiration, Artificial Respiratory Function Tests

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Overall group

Placement of a nasogastric balloon

Group Type EXPERIMENTAL

Placement of nasogastric balloon

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

29 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No