Respiration, Artificial Clinical Trial
— VIREMOfficial title:
Visualization of Inspiratory Effort and Respiratory Mechanics to Promote Lung- and Diaphragm Protective Ventilation
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.
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 |
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 |
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 |
Belgium, Canada,
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 |
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