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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
150
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.
Antwerp University Hospital (UZA)
Edegem, Antwerp, Belgium
RECRUITINGUniversity Hospital Leuven (UZL)
Leuven, Belgium
RECRUITINGThe Hospital for Sick Children (SickKids)
Toronto, Ontario, Canada
RECRUITINGTidal 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.
Time frame: ∆Pes (average over 1 minute recording) at day 1 of mechanical ventilation
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.
Time frame: ∆Pes (average over 1 minute recording) at day 2 of mechanical ventilation
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.
Time frame: ∆Pes (average over 1 minute recording) at day 3 of mechanical ventilation
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.
Time frame: ∆Pes (average over 1 minute recording) at day 4 of mechanical ventilation
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.
Time frame: ∆Pes (average over 1 minute recording) at day 5 of mechanical ventilation
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.
Time frame: ∆Pes (average over 1 minute recording) at day 6 of mechanical ventilation
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.
Time frame: ∆Pes (average over 1 minute recording) at day 7 of mechanical ventilation
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.
Time frame: ∆Pes (average over 1 minute recording) at day 8 of mechanical ventilation
Transpulmonary driving pressure (ΔPL) - D1
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Time frame: ∆PL (average over 1 minute recording) at day 1 of mechanical ventilation
Transpulmonary driving pressure (ΔPL) - D2
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Time frame: ∆PL (average over 1 minute recording) at day 2 of mechanical ventilation
Transpulmonary driving pressure (ΔPL) - D3
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Time frame: ∆PL (average over 1 minute recording) at day 3 of mechanical ventilation
Transpulmonary driving pressure (ΔPL) - D4
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Time frame: ∆PL (average over 1 minute recording) at day 4 of mechanical ventilation
Transpulmonary driving pressure (ΔPL) - D5
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Time frame: ∆PL (average over 1 minute recording) at day 5 of mechanical ventilation
Transpulmonary driving pressure (ΔPL) - D6
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Time frame: ∆PL (average over 1 minute recording) at day 6 of mechanical ventilation
Transpulmonary driving pressure (ΔPL) - D7
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Time frame: ∆PL (average over 1 minute recording) at day 7 of mechanical ventilation
Transpulmonary driving pressure (ΔPL) - D8
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Time frame: ∆PL (average over 1 minute recording) at day 8 of mechanical ventilation
Occlusion pressure (P0.1) - D1
P0.1 is measured during the first 100 milliseconds of a breath
Time frame: P0.1 (average of 3 breaths) at day 1 of mechanical ventilation
Occlusion pressure (P0.1) - D2
P0.1 is measured during the first 100 milliseconds of a breath
Time frame: P0.1 (average of 3 breaths) at day 2 of mechanical ventilation
Occlusion pressure (P0.1) - D3
P0.1 is measured during the first 100 milliseconds of a breath
Time frame: P0.1 (average of 3 breaths) at day 3 of mechanical ventilation
Occlusion pressure (P0.1) - D4
P0.1 is measured during the first 100 milliseconds of a breath
Time frame: P0.1 (average of 3 breaths) at day 4 of mechanical ventilation
Occlusion pressure (P0.1) - D5
P0.1 is measured during the first 100 milliseconds of a breath
Time frame: P0.1 (average of 3 breaths) at day 5 of mechanical ventilation
Occlusion pressure (P0.1) - D6
P0.1 is measured during the first 100 milliseconds of a breath
Time frame: P0.1 (average of 3 breaths) at day 6 of mechanical ventilation
Occlusion pressure (P0.1) - D7
P0.1 is measured during the first 100 milliseconds of a breath
Time frame: P0.1 (average of 3 breaths) at day 7 of mechanical ventilation
Occlusion pressure (P0.1) - D8
P0.1 is measured during the first 100 milliseconds of a breath
Time frame: P0.1 (average of 3 breaths) at day 8 of mechanical ventilation
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.
Time frame: DTee (average of 3 breaths) at day 1 of mechanical ventilation
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.
Time frame: DTee (average of 3 breaths) at day 2 of mechanical ventilation
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.
Time frame: DTee (average of 3 breaths) at day 3 of mechanical ventilation
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.
Time frame: DTee (average of 3 breaths) at day 4 of mechanical ventilation
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.
Time frame: DTee (average of 3 breaths) at day 5 of mechanical ventilation
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.
Time frame: DTee (average of 3 breaths) at day 6 of mechanical ventilation
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.
Time frame: DTee (average of 3 breaths) at day 7 of mechanical ventilation
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.
Time frame: DTee (average of 3 breaths) at day 8 of mechanical ventilation
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.
Time frame: DTF (average of 3 breaths) at day 1 of mechanical ventilation
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.
Time frame: DTF (average of 3 breaths) at day 2 of mechanical ventilation
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.
Time frame: DTF (average of 3 breaths) at day 3 of mechanical ventilation
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.
Time frame: DTF (average of 3 breaths) at day 4 of mechanical ventilation
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.
Time frame: DTF (average of 3 breaths) at day 5 of mechanical ventilation
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.
Time frame: DTF (average of 3 breaths) at day 6 of mechanical ventilation
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.
Time frame: DTF (average of 3 breaths) at day 7 of mechanical ventilation
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.
Time frame: DTF (average of 3 breaths) at day 8 of mechanical ventilation
Duration of mechanical ventilation
Cumulative duration of mechanical ventilation in days (excluding non-invasive ventilation)
Time frame: From date of intubation until the date of extubation or date of death from any cause, whichever came first, assessed up to 4 months
Maximal inspiratory pressure (MIP) - D1
MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Time frame: MIP at day 1 of mechanical ventilation
Maximal inspiratory pressure (MIP) - D2
MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Time frame: MIP at day 2 of mechanical ventilation
Maximal inspiratory pressure (MIP) - D3
MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Time frame: MIP at day 3 of mechanical ventilation
Maximal inspiratory pressure (MIP) - D4
MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Time frame: MIP at day 4 of mechanical ventilation
Maximal inspiratory pressure (MIP) - D5
MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Time frame: MIP at day 5 of mechanical ventilation
Maximal inspiratory pressure (MIP) - D6
MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Time frame: MIP at day 6 of mechanical ventilation
Maximal inspiratory pressure (MIP) - D7
MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Time frame: MIP at day 7 of mechanical ventilation
Maximal inspiratory pressure (MIP) - D8
MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds)
Time frame: MIP at day 8 of mechanical ventilation
Need for tracheal reintubation after tracheal extubation
Time frame: 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
Measured once daily for the first 8 days of mechanical ventilation
Time frame: LUSS at day 1 of mechanical ventilation
Lung ultrasound scores (LUSS) - D2
Measured once daily for the first 8 days of mechanical ventilation
Time frame: LUSS at day 2 of mechanical ventilation
Lung ultrasound scores (LUSS) - D3
Measured once daily for the first 8 days of mechanical ventilation
Time frame: LUSS at day 3 of mechanical ventilation
Lung ultrasound scores (LUSS) - D4
Measured once daily for the first 8 days of mechanical ventilation
Time frame: LUSS at day 4 of mechanical ventilation
Lung ultrasound scores (LUSS) - D5
Measured once daily for the first 8 days of mechanical ventilation
Time frame: LUSS at day 5 of mechanical ventilation
Lung ultrasound scores (LUSS) - D6
Measured once daily for the first 8 days of mechanical ventilation
Time frame: LUSS at day 6 of mechanical ventilation
Lung ultrasound scores (LUSS) - D7
Measured once daily for the first 8 days of mechanical ventilation
Time frame: LUSS at day 7 of mechanical ventilation
Lung ultrasound scores (LUSS) - D8
Measured once daily for the first 8 days of mechanical ventilation
Time frame: LUSS at day 8 of mechanical ventilation
ICU length of stay
Duration to live discharge from the ICU
Time frame: 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
ICU mortality
Time frame: 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
Duration to live discharge from hospital
Time frame: 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 decease
Cumulative time to death counting from the day of intubation
Time frame: From date of intubation until the date of death from any cause, whichever came first, assessed up to 4 months
Hospital mortality
Time frame: 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
Presence of clinical signs of muscle weakness at ICU discharge
Time frame: 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
Presence of clinical signs of muscle weakness at hospital discharge
Time frame: 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
ICU readmission rate within 48 hours
Time frame: 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
Inspiratory muscle pressure (Pmus) - D1
Measured at least once daily for the first 8 days of mechanical ventilation
Time frame: Pmus at day 1 of mechanical ventilation
Inspiratory muscle pressure (Pmus) - D2
Measured at least once daily for the first 8 days of mechanical ventilation
Time frame: Pmus at day 2 of mechanical ventilation
Inspiratory muscle pressure (Pmus) - D3
Measured at least once daily for the first 8 days of mechanical ventilation
Time frame: Pmus at day 3 of mechanical ventilation
Inspiratory muscle pressure (Pmus) - D4
Measured at least once daily for the first 8 days of mechanical ventilation
Time frame: Pmus at day 4 of mechanical ventilation
Inspiratory muscle pressure (Pmus) - D5
Measured at least once daily for the first 8 days of mechanical ventilation
Time frame: Pmus at day 5 of mechanical ventilation
Inspiratory muscle pressure (Pmus) - D6
Measured at least once daily for the first 8 days of mechanical ventilation
Time frame: Pmus at day 6 of mechanical ventilation
Inspiratory muscle pressure (Pmus) - D7
Measured at least once daily for the first 8 days of mechanical ventilation
Time frame: Pmus at day 7 of mechanical ventilation
Inspiratory muscle pressure (Pmus) - D8
Measured at least once daily for the first 8 days of mechanical ventilation
Time frame: Pmus at day 8 of mechanical ventilation
Occlusion pressure (∆Pocc) - D1
Measured at least once daily for the first 8 days of mechanical ventilation
Time frame: ∆Pocc at day 1 of mechanical ventilation
Occlusion pressure (∆Pocc) - D2
Measured at least once daily for the first 8 days of mechanical ventilation
Time frame: ∆Pocc at day 2 of mechanical ventilation
Occlusion pressure (∆Pocc) - D3
Measured at least once daily for the first 8 days of mechanical ventilation
Time frame: ∆Pocc at day 3 of mechanical ventilation
Occlusion pressure (∆Pocc) - D4
Measured at least once daily for the first 8 days of mechanical ventilation
Time frame: ∆Pocc at day 4 of mechanical ventilation
Occlusion pressure (∆Pocc) - D5
Measured at least once daily for the first 8 days of mechanical ventilation
Time frame: ∆Pocc at day 5 of mechanical ventilation
Occlusion pressure (∆Pocc) - D6
Measured at least once daily for the first 8 days of mechanical ventilation
Time frame: ∆Pocc at day 6 of mechanical ventilation
Occlusion pressure (∆Pocc) - D7
Measured at least once daily for the first 8 days of mechanical ventilation
Time frame: ∆Pocc at day 7 of mechanical ventilation
Occlusion pressure (∆Pocc) - D8
Measured at least once daily for the first 8 days of mechanical ventilation
Time frame: ∆Pocc at day 8 of mechanical ventilation
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.
Time frame: PTPes at day 1 of mechanical ventilation
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.
Time frame: PTPes at day 2 of mechanical ventilation
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.
Time frame: PTPes at day 3 of mechanical ventilation
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.
Time frame: PTPes at day 4 of mechanical ventilation
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.
Time frame: PTPes at day 5 of mechanical ventilation
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.
Time frame: PTPes at day 6 of mechanical ventilation
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.
Time frame: PTPes at day 7 of mechanical ventilation
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.
Time frame: PTPes at day 8 of mechanical ventilation
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.
Time frame: VD at day 1 of mechanical ventilation
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.
Time frame: VD at day 2 of mechanical ventilation
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.
Time frame: VD at day 3 of mechanical ventilation
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.
Time frame: VD at day 4 of mechanical ventilation
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.
Time frame: VD at day 5 of mechanical ventilation
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.
Time frame: VD at day 6 of mechanical ventilation
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.
Time frame: VD at day 7 of mechanical ventilation
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.
Time frame: VD at day 8 of mechanical ventilation