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

Respiration, Artificial Clinical Trial

— VIREM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05459116
• Other study ID #: EDGE1712
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: June 2022
• Source: University Hospital, Antwerp
• Contact: Vertongen
• Phone: +323 821 44 04
• Email: icu-research[@]uza.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 1, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 29 Days and older

Eligibility

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

Related Conditions & MeSH terms

• Respiration, Artificial
• Respiratory Aspiration
• Respiratory Function Tests
• Respiratory Muscles

Intervention

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.

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital (UZA)	Edegem	Antwerp
Belgium	University Hospital Leuven (UZL)	Leuven
Canada	The Hospital for Sick Children (SickKids)	Toronto	Ontario

Sponsors (7)

Lead Sponsor	Collaborator
University Hospital, Antwerp	KU Leuven, Research Foundation Flanders, The Hospital for Sick Children, Universitaire Ziekenhuizen KU Leuven, Universiteit Antwerpen, University of Toronto

Countries where clinical trial is conducted

Belgium,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tidal esophageal pressure swing (?Pes) - D1	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.	?Pes (average over 1 minute recording) at day 1 of mechanical ventilation
Primary	Tidal esophageal pressure swing (?Pes) - D2	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.	?Pes (average over 1 minute recording) at day 2 of mechanical ventilation
Primary	Tidal esophageal pressure swing (?Pes) - D3	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.	?Pes (average over 1 minute recording) at day 3 of mechanical ventilation
Primary	Tidal esophageal pressure swing (?Pes) - D4	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.	?Pes (average over 1 minute recording) at day 4 of mechanical ventilation
Primary	Tidal esophageal pressure swing (?Pes) - D5	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.	?Pes (average over 1 minute recording) at day 5 of mechanical ventilation
Primary	Tidal esophageal pressure swing (?Pes) - D6	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.	?Pes (average over 1 minute recording) at day 6 of mechanical ventilation
Primary	Tidal esophageal pressure swing (?Pes) - D7	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.	?Pes (average over 1 minute recording) at day 7 of mechanical ventilation
Primary	Tidal esophageal pressure swing (?Pes) - D8	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.	?Pes (average over 1 minute recording) at day 8 of mechanical ventilation
Secondary	Transpulmonary driving pressure (?PL) - D1	?PL is calculated as change in airway pressure minus change in esophageal pressure	?PL (average over 1 minute recording) at day 1 of mechanical ventilation
Secondary	Transpulmonary driving pressure (?PL) - D2	?PL is calculated as change in airway pressure minus change in esophageal pressure	?PL (average over 1 minute recording) at day 2 of mechanical ventilation
Secondary	Transpulmonary driving pressure (?PL) - D3	?PL is calculated as change in airway pressure minus change in esophageal pressure	?PL (average over 1 minute recording) at day 3 of mechanical ventilation
Secondary	Transpulmonary driving pressure (?PL) - D4	?PL is calculated as change in airway pressure minus change in esophageal pressure	?PL (average over 1 minute recording) at day 4 of mechanical ventilation
Secondary	Transpulmonary driving pressure (?PL) - D5	?PL is calculated as change in airway pressure minus change in esophageal pressure	?PL (average over 1 minute recording) at day 5 of mechanical ventilation
Secondary	Transpulmonary driving pressure (?PL) - D6	?PL is calculated as change in airway pressure minus change in esophageal pressure	?PL (average over 1 minute recording) at day 6 of mechanical ventilation
Secondary	Transpulmonary driving pressure (?PL) - D7	?PL is calculated as change in airway pressure minus change in esophageal pressure	?PL (average over 1 minute recording) at day 7 of mechanical ventilation
Secondary	Transpulmonary driving pressure (?PL) - D8	?PL is calculated as change in airway pressure minus change in esophageal pressure	?PL (average over 1 minute recording) at day 8 of mechanical ventilation
Secondary	Occlusion pressure (P0.1) - D1	P0.1 is measured during the first 100 milliseconds of a breath	P0.1 (average of 3 breaths) at day 1 of mechanical ventilation
Secondary	Occlusion pressure (P0.1) - D2	P0.1 is measured during the first 100 milliseconds of a breath	P0.1 (average of 3 breaths) at day 2 of mechanical ventilation
Secondary	Occlusion pressure (P0.1) - D3	P0.1 is measured during the first 100 milliseconds of a breath	P0.1 (average of 3 breaths) at day 3 of mechanical ventilation
Secondary	Occlusion pressure (P0.1) - D4	P0.1 is measured during the first 100 milliseconds of a breath	P0.1 (average of 3 breaths) at day 4 of mechanical ventilation
Secondary	Occlusion pressure (P0.1) - D5	P0.1 is measured during the first 100 milliseconds of a breath	P0.1 (average of 3 breaths) at day 5 of mechanical ventilation
Secondary	Occlusion pressure (P0.1) - D6	P0.1 is measured during the first 100 milliseconds of a breath	P0.1 (average of 3 breaths) at day 6 of mechanical ventilation
Secondary	Occlusion pressure (P0.1) - D7	P0.1 is measured during the first 100 milliseconds of a breath	P0.1 (average of 3 breaths) at day 7 of mechanical ventilation
Secondary	Occlusion pressure (P0.1) - D8	P0.1 is measured during the first 100 milliseconds of a breath	P0.1 (average of 3 breaths) at day 8 of mechanical ventilation
Secondary	End-expiratory diaphragm thickness (DTee) - D1	Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.	DTee (average of 3 breaths) at day 1 of mechanical ventilation
Secondary	End-expiratory diaphragm thickness (DTee) - D2	Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.	DTee (average of 3 breaths) at day 2 of mechanical ventilation
Secondary	End-expiratory diaphragm thickness (DTee) - D3	Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.	DTee (average of 3 breaths) at day 3 of mechanical ventilation
Secondary	End-expiratory diaphragm thickness (DTee) - D4	Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.	DTee (average of 3 breaths) at day 4 of mechanical ventilation
Secondary	End-expiratory diaphragm thickness (DTee) - D5	Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.	DTee (average of 3 breaths) at day 5 of mechanical ventilation
Secondary	End-expiratory diaphragm thickness (DTee) - D6	Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.	DTee (average of 3 breaths) at day 6 of mechanical ventilation
Secondary	End-expiratory diaphragm thickness (DTee) - D7	Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.	DTee (average of 3 breaths) at day 7 of mechanical ventilation
Secondary	End-expiratory diaphragm thickness (DTee) - D8	Measured with ultrasound. The ultrasound probe will be positioned perpendicular to the skin at the right zone of apposition.	DTee (average of 3 breaths) at day 8 of mechanical ventilation
Secondary	Diaphragm thickening fraction (DTF) measured with ultrasound - D1	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.	DTF (average of 3 breaths) at day 1 of mechanical ventilation
Secondary	Diaphragm thickening fraction (DTF) measured with ultrasound - D2	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.	DTF (average of 3 breaths) at day 2 of mechanical ventilation
Secondary	Diaphragm thickening fraction (DTF) measured with ultrasound - D3	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.	DTF (average of 3 breaths) at day 3 of mechanical ventilation
Secondary	Diaphragm thickening fraction (DTF) measured with ultrasound - D4	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.	DTF (average of 3 breaths) at day 4 of mechanical ventilation
Secondary	Diaphragm thickening fraction (DTF) measured with ultrasound - D5	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.	DTF (average of 3 breaths) at day 5 of mechanical ventilation
Secondary	Diaphragm thickening fraction (DTF) measured with ultrasound - D6	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.	DTF (average of 3 breaths) at day 6 of mechanical ventilation
Secondary	Diaphragm thickening fraction (DTF) measured with ultrasound - D7	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.	DTF (average of 3 breaths) at day 7 of mechanical ventilation
Secondary	Diaphragm thickening fraction (DTF) measured with ultrasound - D8	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.	DTF (average of 3 breaths) at day 8 of mechanical ventilation
Secondary	Duration of mechanical ventilation	Cumulative duration of mechanical ventilation in days (excluding non-invasive 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
Secondary	Maximal inspiratory pressure (MIP) - D1	MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)	MIP at day 1 of mechanical ventilation
Secondary	Maximal inspiratory pressure (MIP) - D2	MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)	MIP at day 2 of mechanical ventilation
Secondary	Maximal inspiratory pressure (MIP) - D3	MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)	MIP at day 3 of mechanical ventilation
Secondary	Maximal inspiratory pressure (MIP) - D4	MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)	MIP at day 4 of mechanical ventilation
Secondary	Maximal inspiratory pressure (MIP) - D5	MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)	MIP at day 5 of mechanical ventilation
Secondary	Maximal inspiratory pressure (MIP) - D6	MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)	MIP at day 6 of mechanical ventilation
Secondary	Maximal inspiratory pressure (MIP) - D7	MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)	MIP at day 7 of mechanical ventilation
Secondary	Maximal inspiratory pressure (MIP) - D8	MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)	MIP at day 8 of mechanical ventilation
Secondary	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.
Secondary	Lung ultrasound scores (LUSS) - D1	Measured once daily for the first 8 days of mechanical ventilation	LUSS at day 1 of mechanical ventilation
Secondary	Lung ultrasound scores (LUSS) - D2	Measured once daily for the first 8 days of mechanical ventilation	LUSS at day 2 of mechanical ventilation
Secondary	Lung ultrasound scores (LUSS) - D3	Measured once daily for the first 8 days of mechanical ventilation	LUSS at day 3 of mechanical ventilation
Secondary	Lung ultrasound scores (LUSS) - D4	Measured once daily for the first 8 days of mechanical ventilation	LUSS at day 4 of mechanical ventilation
Secondary	Lung ultrasound scores (LUSS) - D5	Measured once daily for the first 8 days of mechanical ventilation	LUSS at day 5 of mechanical ventilation
Secondary	Lung ultrasound scores (LUSS) - D6	Measured once daily for the first 8 days of mechanical ventilation	LUSS at day 6 of mechanical ventilation
Secondary	Lung ultrasound scores (LUSS) - D7	Measured once daily for the first 8 days of mechanical ventilation	LUSS at day 7 of mechanical ventilation
Secondary	Lung ultrasound scores (LUSS) - D8	Measured once daily for the first 8 days of mechanical ventilation	LUSS at day 8 of mechanical ventilation
Secondary	ICU length of stay	Duration to live discharge from the ICU	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
Secondary	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
Secondary	Hospital length of stay	Duration to live discharge from hospital	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
Secondary	Duration to decease	Cumulative time to death counting from the day of intubation	From date of intubation until the date of death from any cause, whichever came first, assessed up to 4 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Inspiratory muscle pressure (Pmus) - D1	Measured at least once daily for the first 8 days of mechanical ventilation	Pmus at day 1 of mechanical ventilation
Secondary	Inspiratory muscle pressure (Pmus) - D2	Measured at least once daily for the first 8 days of mechanical ventilation	Pmus at day 2 of mechanical ventilation
Secondary	Inspiratory muscle pressure (Pmus) - D3	Measured at least once daily for the first 8 days of mechanical ventilation	Pmus at day 3 of mechanical ventilation
Secondary	Inspiratory muscle pressure (Pmus) - D4	Measured at least once daily for the first 8 days of mechanical ventilation	Pmus at day 4 of mechanical ventilation
Secondary	Inspiratory muscle pressure (Pmus) - D5	Measured at least once daily for the first 8 days of mechanical ventilation	Pmus at day 5 of mechanical ventilation
Secondary	Inspiratory muscle pressure (Pmus) - D6	Measured at least once daily for the first 8 days of mechanical ventilation	Pmus at day 6 of mechanical ventilation
Secondary	Inspiratory muscle pressure (Pmus) - D7	Measured at least once daily for the first 8 days of mechanical ventilation	Pmus at day 7 of mechanical ventilation
Secondary	Inspiratory muscle pressure (Pmus) - D8	Measured at least once daily for the first 8 days of mechanical ventilation	Pmus at day 8 of mechanical ventilation
Secondary	Occlusion pressure (?Pocc) - D1	Measured at least once daily for the first 8 days of mechanical ventilation	?Pocc at day 1 of mechanical ventilation
Secondary	Occlusion pressure (?Pocc) - D2	Measured at least once daily for the first 8 days of mechanical ventilation	?Pocc at day 2 of mechanical ventilation
Secondary	Occlusion pressure (?Pocc) - D3	Measured at least once daily for the first 8 days of mechanical ventilation	?Pocc at day 3 of mechanical ventilation
Secondary	Occlusion pressure (?Pocc) - D4	Measured at least once daily for the first 8 days of mechanical ventilation	?Pocc at day 4 of mechanical ventilation
Secondary	Occlusion pressure (?Pocc) - D5	Measured at least once daily for the first 8 days of mechanical ventilation	?Pocc at day 5 of mechanical ventilation
Secondary	Occlusion pressure (?Pocc) - D6	Measured at least once daily for the first 8 days of mechanical ventilation	?Pocc at day 6 of mechanical ventilation
Secondary	Occlusion pressure (?Pocc) - D7	Measured at least once daily for the first 8 days of mechanical ventilation	?Pocc at day 7 of mechanical ventilation
Secondary	Occlusion pressure (?Pocc) - D8	Measured at least once daily for the first 8 days of mechanical ventilation	?Pocc at day 8 of mechanical ventilation
Secondary	Esophageal pressure-time product (PTPes) - D1	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.	PTPes at day 1 of mechanical ventilation
Secondary	Esophageal pressure-time product (PTPes) - D2	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.	PTPes at day 2 of mechanical ventilation
Secondary	Esophageal pressure-time product (PTPes) - D3	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.	PTPes at day 3 of mechanical ventilation
Secondary	Esophageal pressure-time product (PTPes) - D4	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.	PTPes at day 4 of mechanical ventilation
Secondary	Esophageal pressure-time product (PTPes) - D5	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.	PTPes at day 5 of mechanical ventilation
Secondary	Esophageal pressure-time product (PTPes) - D6	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.	PTPes at day 6 of mechanical ventilation
Secondary	Esophageal pressure-time product (PTPes) - D7	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.	PTPes at day 7 of mechanical ventilation
Secondary	Esophageal pressure-time product (PTPes) - D8	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.	PTPes at day 8 of mechanical ventilation
Secondary	Dead space ventilation (VD) - D1	Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.	VD at day 1 of mechanical ventilation
Secondary	Dead space ventilation (VD) - D2	Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.	VD at day 2 of mechanical ventilation
Secondary	Dead space ventilation (VD) - D3	Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.	VD at day 3 of mechanical ventilation
Secondary	Dead space ventilation (VD) - D4	Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.	VD at day 4 of mechanical ventilation
Secondary	Dead space ventilation (VD) - D5	Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.	VD at day 5 of mechanical ventilation
Secondary	Dead space ventilation (VD) - D6	Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.	VD at day 6 of mechanical ventilation
Secondary	Dead space ventilation (VD) - D7	Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.	VD at day 7 of mechanical ventilation
Secondary	Dead space ventilation (VD) - D8	Measured with volumetric capnography (Capnostat 5, Philips) in adults only. Measured at least once daily for the first 8 days of mechanical ventilation.	VD at day 8 of mechanical ventilation