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

Not Applicable

Recruiting

• Conditions: Respiratory Function Tests; Respiratory Muscles; Respiration, Artificial
• Interventions: Device: Placement of nasogastric balloon

• Registration Number: NCT05459116
• Lead Sponsor: University Hospital, Antwerp

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-28
• Study First Submitted QC: 2022-07-11
• Study First Posted: 2022-07-14
• Study Start: 2022-09-21
• Status Verified: 2024-09
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Overall group	Placement of nasogastric balloon	Placement of a nasogastric balloon

Primary Outcome Measures

Name	Time	Method
Tidal esophageal pressure swing (∆Pes) - D1	∆Pes (average over 1 minute recording) at day 1 of mechanical ventilation	Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Tidal esophageal pressure swing (∆Pes) - D7	∆Pes (average over 1 minute recording) at day 7 of mechanical ventilation	Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Tidal esophageal pressure swing (∆Pes) - D2	∆Pes (average over 1 minute recording) at day 2 of mechanical ventilation	Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Tidal esophageal pressure swing (∆Pes) - D3	∆Pes (average over 1 minute recording) at day 3 of mechanical ventilation	Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Tidal esophageal pressure swing (∆Pes) - D4	∆Pes (average over 1 minute recording) at day 4 of mechanical ventilation	Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Tidal esophageal pressure swing (∆Pes) - D8	∆Pes (average over 1 minute recording) at day 8 of mechanical ventilation	Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Tidal esophageal pressure swing (∆Pes) - D5	∆Pes (average over 1 minute recording) at day 5 of mechanical ventilation	Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.
Tidal esophageal pressure swing (∆Pes) - D6	∆Pes (average over 1 minute recording) at day 6 of mechanical ventilation	Our primary endpoint is the amount of total inspiratory muscle activity as represented by ∆Pes, measured at least once daily during the first 8 days of mechanical ventilation.

Secondary Outcome Measures

Name	Time	Method
Occlusion pressure (P0.1) - D2	P0.1 (average of 3 breaths) at day 2 of mechanical ventilation	P0.1 is measured during the first 100 milliseconds of a breath
Occlusion pressure (P0.1) - D5	P0.1 (average of 3 breaths) at day 5 of mechanical ventilation	P0.1 is measured during the first 100 milliseconds of a breath
Lung ultrasound scores (LUSS) - D7	LUSS at day 7 of mechanical ventilation	Measured once daily for the first 8 days of mechanical ventilation
ICU mortality	From date of inclusion until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 4 months
Hospital length of stay	From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 months	Duration to live discharge from hospital
Dead space ventilation (VD) - D1	VD at day 1 of mechanical ventilation	Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.
Dead space ventilation (VD) - D8	VD at day 8 of mechanical ventilation	Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.
Transpulmonary driving pressure (ΔPL) - D6	∆PL (average over 1 minute recording) at day 6 of mechanical ventilation	∆PL is calculated as change in airway pressure minus change in esophageal pressure
Occlusion pressure (P0.1) - D1	P0.1 (average of 3 breaths) at day 1 of mechanical ventilation	P0.1 is measured during the first 100 milliseconds of a breath
Transpulmonary driving pressure (ΔPL) - D1	∆PL (average over 1 minute recording) at day 1 of mechanical ventilation	∆PL is calculated as change in airway pressure minus change in esophageal pressure
Inspiratory muscle pressure (Pmus) - D3	Pmus at day 3 of mechanical ventilation	Measured at least once daily for the first 8 days of mechanical ventilation
Inspiratory muscle pressure (Pmus) - D5	Pmus at day 5 of mechanical ventilation	Measured at least once daily for the first 8 days of mechanical ventilation
Inspiratory muscle pressure (Pmus) - D4	Pmus at day 4 of mechanical ventilation	Measured at least once daily for the first 8 days of mechanical ventilation
Maximal inspiratory pressure (MIP) - D8	MIP at day 8 of mechanical ventilation	MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Transpulmonary driving pressure (ΔPL) - D4	∆PL (average over 1 minute recording) at day 4 of mechanical ventilation	∆PL is calculated as change in airway pressure minus change in esophageal pressure
Transpulmonary driving pressure (ΔPL) - D7	∆PL (average over 1 minute recording) at day 7 of mechanical ventilation	∆PL is calculated as change in airway pressure minus change in esophageal pressure
Transpulmonary driving pressure (ΔPL) - D8	∆PL (average over 1 minute recording) at day 8 of mechanical ventilation	∆PL is calculated as change in airway pressure minus change in esophageal pressure
End-expiratory diaphragm thickness (DTee) - D1	DTee (average of 3 breaths) at day 1 of mechanical ventilation	Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Transpulmonary driving pressure (ΔPL) - D3	∆PL (average over 1 minute recording) at day 3 of mechanical ventilation	∆PL is calculated as change in airway pressure minus change in esophageal pressure
Transpulmonary driving pressure (ΔPL) - D2	∆PL (average over 1 minute recording) at day 2 of mechanical ventilation	∆PL is calculated as change in airway pressure minus change in esophageal pressure
End-expiratory diaphragm thickness (DTee) - D5	DTee (average of 3 breaths) at day 5 of mechanical ventilation	Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
End-expiratory diaphragm thickness (DTee) - D8	DTee (average of 3 breaths) at day 8 of mechanical ventilation	Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Diaphragm thickening fraction (DTF) measured with ultrasound - D5	DTF (average of 3 breaths) at day 5 of mechanical ventilation	DTF is calculated as (Thickness at end-inspiration \[DTei\] - Thickness at end-expiration \[DTee\])/Thickness at end-expiration \[DTee\] × 100.; The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Occlusion pressure (P0.1) - D6	P0.1 (average of 3 breaths) at day 6 of mechanical ventilation	P0.1 is measured during the first 100 milliseconds of a breath
Lung ultrasound scores (LUSS) - D6	LUSS at day 6 of mechanical ventilation	Measured once daily for the first 8 days of mechanical ventilation
Diaphragm thickening fraction (DTF) measured with ultrasound - D3	DTF (average of 3 breaths) at day 3 of mechanical ventilation	DTF is calculated as (Thickness at end-inspiration \[DTei\] - Thickness at end-expiration \[DTee\])/Thickness at end-expiration \[DTee\] × 100.; The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Maximal inspiratory pressure (MIP) - D5	MIP at day 5 of mechanical ventilation	MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Maximal inspiratory pressure (MIP) - D6	MIP at day 6 of mechanical ventilation	MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Need for tracheal reintubation after tracheal extubation	From date of inclusion until the date of reintubation or date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 months.
Lung ultrasound scores (LUSS) - D1	LUSS at day 1 of mechanical ventilation	Measured once daily for the first 8 days of mechanical ventilation
Transpulmonary driving pressure (ΔPL) - D5	∆PL (average over 1 minute recording) at day 5 of mechanical ventilation	∆PL is calculated as change in airway pressure minus change in esophageal pressure
Occlusion pressure (P0.1) - D4	P0.1 (average of 3 breaths) at day 4 of mechanical ventilation	P0.1 is measured during the first 100 milliseconds of a breath
End-expiratory diaphragm thickness (DTee) - D2	DTee (average of 3 breaths) at day 2 of mechanical ventilation	Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
End-expiratory diaphragm thickness (DTee) - D4	DTee (average of 3 breaths) at day 4 of mechanical ventilation	Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Diaphragm thickening fraction (DTF) measured with ultrasound - D1	DTF (average of 3 breaths) at day 1 of mechanical ventilation	DTF is calculated as (Thickness at end-inspiration \[DTei\] - Thickness at end-expiration \[DTee\])/Thickness at end-expiration \[DTee\] × 100.; The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Maximal inspiratory pressure (MIP) - D4	MIP at day 4 of mechanical ventilation	MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Diaphragm thickening fraction (DTF) measured with ultrasound - D8	DTF (average of 3 breaths) at day 8 of mechanical ventilation	DTF is calculated as (Thickness at end-inspiration \[DTei\] - Thickness at end-expiration \[DTee\])/Thickness at end-expiration \[DTee\] × 100.; The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Maximal inspiratory pressure (MIP) - D1	MIP at day 1 of mechanical ventilation	MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Lung ultrasound scores (LUSS) - D2	LUSS at day 2 of mechanical ventilation	Measured once daily for the first 8 days of mechanical ventilation
Lung ultrasound scores (LUSS) - D5	LUSS at day 5 of mechanical ventilation	Measured once daily for the first 8 days of mechanical ventilation
Lung ultrasound scores (LUSS) - D8	LUSS at day 8 of mechanical ventilation	Measured once daily for the first 8 days of mechanical ventilation
Duration to decease	From date of intubation until the date of death from any cause, whichever came first, assessed up to 4 months	Cumulative time to death counting from the day of intubation
Occlusion pressure (P0.1) - D3	P0.1 (average of 3 breaths) at day 3 of mechanical ventilation	P0.1 is measured during the first 100 milliseconds of a breath
Occlusion pressure (P0.1) - D7	P0.1 (average of 3 breaths) at day 7 of mechanical ventilation	P0.1 is measured during the first 100 milliseconds of a breath
Occlusion pressure (P0.1) - D8	P0.1 (average of 3 breaths) at day 8 of mechanical ventilation	P0.1 is measured during the first 100 milliseconds of a breath
End-expiratory diaphragm thickness (DTee) - D3	DTee (average of 3 breaths) at day 3 of mechanical ventilation	Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
End-expiratory diaphragm thickness (DTee) - D6	DTee (average of 3 breaths) at day 6 of mechanical ventilation	Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
End-expiratory diaphragm thickness (DTee) - D7	DTee (average of 3 breaths) at day 7 of mechanical ventilation	Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Presence of clinical signs of muscle weakness at ICU discharge	From date of inclusion until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 4 months
Inspiratory muscle pressure (Pmus) - D1	Pmus at day 1 of mechanical ventilation	Measured at least once daily for the first 8 days of mechanical ventilation
Diaphragm thickening fraction (DTF) measured with ultrasound - D2	DTF (average of 3 breaths) at day 2 of mechanical ventilation	DTF is calculated as (Thickness at end-inspiration \[DTei\] - Thickness at end-expiration \[DTee\])/Thickness at end-expiration \[DTee\] × 100.; The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Diaphragm thickening fraction (DTF) measured with ultrasound - D4	DTF (average of 3 breaths) at day 4 of mechanical ventilation	DTF is calculated as (Thickness at end-inspiration \[DTei\] - Thickness at end-expiration \[DTee\])/Thickness at end-expiration \[DTee\] × 100.; The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Diaphragm thickening fraction (DTF) measured with ultrasound - D6	DTF (average of 3 breaths) at day 6 of mechanical ventilation	DTF is calculated as (Thickness at end-inspiration \[DTei\] - Thickness at end-expiration \[DTee\])/Thickness at end-expiration \[DTee\] × 100.; The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Maximal inspiratory pressure (MIP) - D2	MIP at day 2 of mechanical ventilation	MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Maximal inspiratory pressure (MIP) - D3	MIP at day 3 of mechanical ventilation	MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Lung ultrasound scores (LUSS) - D3	LUSS at day 3 of mechanical ventilation	Measured once daily for the first 8 days of mechanical ventilation
ICU length of stay	From date of ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 4 months	Duration to live discharge from the ICU
ICU readmission rate within 48 hours	From date of ICU discharge until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 months
Diaphragm thickening fraction (DTF) measured with ultrasound - D7	DTF (average of 3 breaths) at day 7 of mechanical ventilation	DTF is calculated as (Thickness at end-inspiration \[DTei\] - Thickness at end-expiration \[DTee\])/Thickness at end-expiration \[DTee\] × 100.; The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.
Duration of mechanical ventilation	From date of intubation until the date of extubation or date of death from any cause, whichever came first, assessed up to 4 months	Cumulative duration of mechanical ventilation in days (excluding non-invasive ventilation)
Maximal inspiratory pressure (MIP) - D7	MIP at day 7 of mechanical ventilation	MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Lung ultrasound scores (LUSS) - D4	LUSS at day 4 of mechanical ventilation	Measured once daily for the first 8 days of mechanical ventilation
Hospital mortality	From date of inclusion until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 months
Occlusion pressure (∆Pocc) - D1	∆Pocc at day 1 of mechanical ventilation	Measured at least once daily for the first 8 days of mechanical ventilation
Occlusion pressure (∆Pocc) - D3	∆Pocc at day 3 of mechanical ventilation	Measured at least once daily for the first 8 days of mechanical ventilation
Occlusion pressure (∆Pocc) - D5	∆Pocc at day 5 of mechanical ventilation	Measured at least once daily for the first 8 days of mechanical ventilation
Occlusion pressure (∆Pocc) - D6	∆Pocc at day 6 of mechanical ventilation	Measured at least once daily for the first 8 days of mechanical ventilation
Esophageal pressure-time product (PTPes) - D4	PTPes at day 4 of mechanical ventilation	Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.
Dead space ventilation (VD) - D3	VD at day 3 of mechanical ventilation	Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.
Dead space ventilation (VD) - D6	VD at day 6 of mechanical ventilation	Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.
Presence of clinical signs of muscle weakness at hospital discharge	From date of inclusion until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 months
Inspiratory muscle pressure (Pmus) - D2	Pmus at day 2 of mechanical ventilation	Measured at least once daily for the first 8 days of mechanical ventilation
Inspiratory muscle pressure (Pmus) - D8	Pmus at day 8 of mechanical ventilation	Measured at least once daily for the first 8 days of mechanical ventilation
Occlusion pressure (∆Pocc) - D2	∆Pocc at day 2 of mechanical ventilation	Measured at least once daily for the first 8 days of mechanical ventilation
Esophageal pressure-time product (PTPes) - D5	PTPes at day 5 of mechanical ventilation	Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.
Inspiratory muscle pressure (Pmus) - D6	Pmus at day 6 of mechanical ventilation	Measured at least once daily for the first 8 days of mechanical ventilation
Occlusion pressure (∆Pocc) - D7	∆Pocc at day 7 of mechanical ventilation	Measured at least once daily for the first 8 days of mechanical ventilation
Occlusion pressure (∆Pocc) - D8	∆Pocc at day 8 of mechanical ventilation	Measured at least once daily for the first 8 days of mechanical ventilation
Esophageal pressure-time product (PTPes) - D3	PTPes at day 3 of mechanical ventilation	Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.
Inspiratory muscle pressure (Pmus) - D7	Pmus at day 7 of mechanical ventilation	Measured at least once daily for the first 8 days of mechanical ventilation
Occlusion pressure (∆Pocc) - D4	∆Pocc at day 4 of mechanical ventilation	Measured at least once daily for the first 8 days of mechanical ventilation
Esophageal pressure-time product (PTPes) - D2	PTPes at day 2 of mechanical ventilation	Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.
Esophageal pressure-time product (PTPes) - D7	PTPes at day 7 of mechanical ventilation	Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.
Dead space ventilation (VD) - D4	VD at day 4 of mechanical ventilation	Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.
Esophageal pressure-time product (PTPes) - D1	PTPes at day 1 of mechanical ventilation	Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.
Esophageal pressure-time product (PTPes) - D6	PTPes at day 6 of mechanical ventilation	Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.
Esophageal pressure-time product (PTPes) - D8	PTPes at day 8 of mechanical ventilation	Area under the curve (AUC) of the Pes-time plot during inspiration. Measured at least once daily for the first 8 days of mechanical ventilation.
Dead space ventilation (VD) - D2	VD at day 2 of mechanical ventilation	Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.
Dead space ventilation (VD) - D5	VD at day 5 of mechanical ventilation	Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.
Dead space ventilation (VD) - D7	VD at day 7 of mechanical ventilation	Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.

Trial Locations

Locations (3)

Antwerp University Hospital (UZA); 🇧🇪 Edegem, Antwerp, Belgium

University Hospital Leuven (UZL); 🇧🇪 Leuven, Belgium

The Hospital for Sick Children (SickKids); 🇨🇦 Toronto, Ontario, Canada