Respiration, Artificial, Respiratory Function Tests, Respiratory Muscles
Conditions
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.
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.
Sponsors
Research Foundation Flanders
Universitaire Ziekenhuizen KU Leuven
The Hospital for Sick Children
University of Toronto
Universiteit Antwerpen
KU Leuven
University Hospital, Antwerp
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
29 Days to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) - 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) - 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. |
| 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) - 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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) - 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) - 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 |
| 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 |
| 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 |
| 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. | — |
| 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 |
| 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 |
| 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) - 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) - 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 |
| Lung ultrasound scores (LUSS) - D1 | LUSS at day 1 of mechanical ventilation | Measured once daily for the first 8 days of mechanical ventilation |
| 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 |
| 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 |
| 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) - 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. |
| 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) - 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) - 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. |
| 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) - 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. |
| 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 - 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. |
| 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 - 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. |
| 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 - 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. |
| 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. |
| 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. |
| 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. |
| 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) - D1 | MIP at day 1 of mechanical ventilation | MIP is a measure of inspiratory function. Measured once daily during an expiratory hold (± 30 seconds) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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 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 |
| 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 |
| 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 | — |
| 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 | — |
| 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 | — |
| 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 | — |
| 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 |
| 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) - 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) - D4 | Pmus at day 4 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) - D6 | Pmus at day 6 of mechanical ventilation | 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 |
| 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) - D1 | ∆Pocc at day 1 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 |
| 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) - D4 | ∆Pocc at day 4 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 |
| 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) - 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) - 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) - 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. |
| 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. |
| 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. |
| 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) - 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. |
| 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) - 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) - 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) - 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. |
| Lung ultrasound scores (LUSS) - D2 | LUSS at day 2 of mechanical ventilation | Measured 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) - 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. |
| 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. |
| 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. |
| 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. |
| Lung ultrasound scores (LUSS) - D3 | LUSS at day 3 of mechanical ventilation | Measured once daily for the first 8 days of mechanical ventilation |
| Lung ultrasound scores (LUSS) - D4 | LUSS at day 4 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) - D6 | LUSS at day 6 of mechanical ventilation | Measured once daily for the first 8 days of mechanical ventilation |
| Lung ultrasound scores (LUSS) - D7 | LUSS at day 7 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 |
| 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) |
Countries
Belgium, Canada
Contacts
Primary ContactVertongen
Backup ContactMarquez
Outcome results
None listed