Respiratory MusclesVIREMNCT05459116
Visualization of Inspiratory Effort and Respiratory Mechanics to Promote Lung- and Diaphragm Protective Ventilation
A study testing Placement of nasogastric balloon in people with Respiratory Muscles and Respiration, Artificial, run by University Hospital, Antwerp at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 29 days and older
- Conditions the study is for
- Respiratory Muscles, Respiration, Artificial, Respiratory Function Tests
- What is being tested?
- Placement of nasogastric balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 21 Sep 2022to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age > 28 days
- weight > 3kg
- requiring invasive mechanical ventilation
- anticipated length of ventilation > 48h
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Belgium2 sites, 2 recruiting
- Recruiting
Antwerp University Hospital (UZA)
Edegem, Antwerp, 2650
Vertongen, +323 821 44 04, icu-research@uza.be
Tom Schepens, M.D., Ph.D.
- Recruiting
University Hospital Leuven (UZL)
Leuven, 3000
Van Maercke, francesca.vanmaercke@uzleuven.be
Greet Hermans, M.D., Ph.D.
Canada1 site, 1 recruiting
- Recruiting
The Hospital for Sick Children (SickKids)
Toronto, Ontario, M5G 1X8
Ta, eva.ta@sickkids.ca
Gail Annich, M.D.
About this study
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.
- Being tested
- Placement of nasogastric balloon
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of nasogastric balloonDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Overall group | Experimental | Placement of a nasogastric balloon Receives: Device: Placement of nasogastric balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ∆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.
Measured: ∆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.
Measured: ∆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.
Measured: ∆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.
Measured: ∆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.
Measured: ∆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.
Measured: ∆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.
Measured: ∆Pes (average over 1 minute recording) at day 8 of mechanical ventilation
Secondary outcomes (90)
Transpulmonary driving pressure (ΔPL) - D1
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Measured: ∆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
Measured: ∆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
Measured: ∆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
Measured: ∆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
Measured: ∆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
Measured: ∆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
Measured: ∆PL (average over 1 minute recording) at day 7 of mechanical ventilation
Transpulmonary driving pressure (ΔPL) - D8
∆PL is calculated as change in airway pressure minus change in esophageal pressure
Measured: ∆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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: MIP at day 8 of mechanical ventilation
Need for tracheal reintubation after tracheal extubation
Measured: 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
Measured: LUSS at day 1 of mechanical ventilation
Lung ultrasound scores (LUSS) - D2
Measured once daily for the first 8 days of mechanical ventilation
Measured: LUSS at day 2 of mechanical ventilation
Lung ultrasound scores (LUSS) - D3
Measured once daily for the first 8 days of mechanical ventilation
Measured: LUSS at day 3 of mechanical ventilation
Lung ultrasound scores (LUSS) - D4
Measured once daily for the first 8 days of mechanical ventilation
Measured: LUSS at day 4 of mechanical ventilation
Lung ultrasound scores (LUSS) - D5
Measured once daily for the first 8 days of mechanical ventilation
Measured: LUSS at day 5 of mechanical ventilation
Lung ultrasound scores (LUSS) - D6
Measured once daily for the first 8 days of mechanical ventilation
Measured: LUSS at day 6 of mechanical ventilation
Lung ultrasound scores (LUSS) - D7
Measured once daily for the first 8 days of mechanical ventilation
Measured: LUSS at day 7 of mechanical ventilation
Lung ultrasound scores (LUSS) - D8
Measured once daily for the first 8 days of mechanical ventilation
Measured: LUSS at day 8 of mechanical ventilation
ICU length of stay
Duration to live discharge from the ICU
Measured: 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
Measured: 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
Measured: 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
Measured: From date of intubation until the date of death from any cause, whichever came first, assessed up to 4 months
Hospital mortality
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Pmus at day 8 of mechanical ventilation
Occlusion pressure (∆Pocc) - D1
Measured at least once daily for the first 8 days of mechanical ventilation
Measured: ∆Pocc at day 1 of mechanical ventilation
Occlusion pressure (∆Pocc) - D2
Measured at least once daily for the first 8 days of mechanical ventilation
Measured: ∆Pocc at day 2 of mechanical ventilation
Occlusion pressure (∆Pocc) - D3
Measured at least once daily for the first 8 days of mechanical ventilation
Measured: ∆Pocc at day 3 of mechanical ventilation
Occlusion pressure (∆Pocc) - D4
Measured at least once daily for the first 8 days of mechanical ventilation
Measured: ∆Pocc at day 4 of mechanical ventilation
Occlusion pressure (∆Pocc) - D5
Measured at least once daily for the first 8 days of mechanical ventilation
Measured: ∆Pocc at day 5 of mechanical ventilation
Occlusion pressure (∆Pocc) - D6
Measured at least once daily for the first 8 days of mechanical ventilation
Measured: ∆Pocc at day 6 of mechanical ventilation
Occlusion pressure (∆Pocc) - D7
Measured at least once daily for the first 8 days of mechanical ventilation
Measured: ∆Pocc at day 7 of mechanical ventilation
Occlusion pressure (∆Pocc) - D8
Measured at least once daily for the first 8 days of mechanical ventilation
Measured: ∆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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: VD at day 8 of mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start21 Sep 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory MusclesStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders, Universitaire Ziekenhuizen KU Leuven, The Hospital for Sick Children, University of Toronto, Universiteit Antwerpen, KU Leuven
- Responsible party
- Sponsor
- Investigators
- Tom Schepens, M.D., Ph.D., Study director, PICU staff member
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459116
- Sponsor's protocol ID
- EDGE1712
- Acronym
- VIREM
- Status last verified
- Sep 2024
- First submitted
- 28 Jun 2022
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visualization of Inspiratory Effort and Respiratory Mechanics to Promote Lung- and Diaphragm Protective Ventilation
- ClinicalTrials.gov ID
- NCT05459116
- Acronym / sponsor ID
- VIREM / EDGE1712
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Research Foundation Flanders, Universitaire Ziekenhuizen KU Leuven, The Hospital for Sick Children, University of Toronto, Universiteit Antwerpen, KU Leuven
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall group | Experimental | Device: Placement of nasogastric balloonPlacement of a nasogastric balloon |
Who may qualify
- Ages
- 29 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- age > 28 days
- weight > 3kg
- requiring invasive mechanical ventilation
- anticipated length of ventilation > 48h
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placement of nasogastric balloonA 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. | Device | Overall group |
Primary outcome
Tidal esophageal pressure swing (∆Pes) - D1
Time frame: ∆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
Time frame: ∆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
Time frame: ∆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
Time frame: ∆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
Time frame: ∆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
Time frame: ∆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
Time frame: ∆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
Time frame: ∆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.
90 secondary outcomes
Transpulmonary driving pressure (ΔPL) - D1
Time frame: ∆PL (average over 1 minute recording) at day 1 of mechanical ventilation
Transpulmonary driving pressure (ΔPL) - D2
Time frame: ∆PL (average over 1 minute recording) at day 2 of mechanical ventilation
Transpulmonary driving pressure (ΔPL) - D3
Time frame: ∆PL (average over 1 minute recording) at day 3 of mechanical ventilation
Transpulmonary driving pressure (ΔPL) - D4
Time frame: ∆PL (average over 1 minute recording) at day 4 of mechanical ventilation
Transpulmonary driving pressure (ΔPL) - D5
Time frame: ∆PL (average over 1 minute recording) at day 5 of mechanical ventilation
Transpulmonary driving pressure (ΔPL) - D6
Time frame: ∆PL (average over 1 minute recording) at day 6 of mechanical ventilation
Transpulmonary driving pressure (ΔPL) - D7
Time frame: ∆PL (average over 1 minute recording) at day 7 of mechanical ventilation
Transpulmonary driving pressure (ΔPL) - D8
Time frame: ∆PL (average over 1 minute recording) at day 8 of mechanical ventilation
Occlusion pressure (P0.1) - D1
Time frame: P0.1 (average of 3 breaths) at day 1 of mechanical ventilation
Occlusion pressure (P0.1) - D2
Time frame: P0.1 (average of 3 breaths) at day 2 of mechanical ventilation
Occlusion pressure (P0.1) - D3
Time frame: P0.1 (average of 3 breaths) at day 3 of mechanical ventilation
Occlusion pressure (P0.1) - D4
Time frame: P0.1 (average of 3 breaths) at day 4 of mechanical ventilation
Occlusion pressure (P0.1) - D5
Time frame: P0.1 (average of 3 breaths) at day 5 of mechanical ventilation
Occlusion pressure (P0.1) - D6
Time frame: P0.1 (average of 3 breaths) at day 6 of mechanical ventilation
Occlusion pressure (P0.1) - D7
Time frame: P0.1 (average of 3 breaths) at day 7 of mechanical ventilation
Occlusion pressure (P0.1) - D8
Time frame: P0.1 (average of 3 breaths) at day 8 of mechanical ventilation
End-expiratory diaphragm thickness (DTee) - D1
Time frame: DTee (average of 3 breaths) at day 1 of mechanical ventilation
End-expiratory diaphragm thickness (DTee) - D2
Time frame: DTee (average of 3 breaths) at day 2 of mechanical ventilation
End-expiratory diaphragm thickness (DTee) - D3
Time frame: DTee (average of 3 breaths) at day 3 of mechanical ventilation
End-expiratory diaphragm thickness (DTee) - D4
Time frame: DTee (average of 3 breaths) at day 4 of mechanical ventilation
End-expiratory diaphragm thickness (DTee) - D5
Time frame: DTee (average of 3 breaths) at day 5 of mechanical ventilation
End-expiratory diaphragm thickness (DTee) - D6
Time frame: DTee (average of 3 breaths) at day 6 of mechanical ventilation
End-expiratory diaphragm thickness (DTee) - D7
Time frame: DTee (average of 3 breaths) at day 7 of mechanical ventilation
End-expiratory diaphragm thickness (DTee) - D8
Time frame: DTee (average of 3 breaths) at day 8 of mechanical ventilation
Diaphragm thickening fraction (DTF) measured with ultrasound - D1
Time frame: DTF (average of 3 breaths) at day 1 of mechanical ventilation
Diaphragm thickening fraction (DTF) measured with ultrasound - D2
Time frame: DTF (average of 3 breaths) at day 2 of mechanical ventilation
Diaphragm thickening fraction (DTF) measured with ultrasound - D3
Time frame: DTF (average of 3 breaths) at day 3 of mechanical ventilation
Diaphragm thickening fraction (DTF) measured with ultrasound - D4
Time frame: DTF (average of 3 breaths) at day 4 of mechanical ventilation
Diaphragm thickening fraction (DTF) measured with ultrasound - D5
Time frame: DTF (average of 3 breaths) at day 5 of mechanical ventilation
Diaphragm thickening fraction (DTF) measured with ultrasound - D6
Time frame: DTF (average of 3 breaths) at day 6 of mechanical ventilation
Diaphragm thickening fraction (DTF) measured with ultrasound - D7
Time frame: DTF (average of 3 breaths) at day 7 of mechanical ventilation
Diaphragm thickening fraction (DTF) measured with ultrasound - D8
Time frame: DTF (average of 3 breaths) at day 8 of mechanical ventilation
Duration of mechanical 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
Time frame: MIP at day 1 of mechanical ventilation
Maximal inspiratory pressure (MIP) - D2
Time frame: MIP at day 2 of mechanical ventilation
Maximal inspiratory pressure (MIP) - D3
Time frame: MIP at day 3 of mechanical ventilation
Maximal inspiratory pressure (MIP) - D4
Time frame: MIP at day 4 of mechanical ventilation
Maximal inspiratory pressure (MIP) - D5
Time frame: MIP at day 5 of mechanical ventilation
Maximal inspiratory pressure (MIP) - D6
Time frame: MIP at day 6 of mechanical ventilation
Maximal inspiratory pressure (MIP) - D7
Time frame: MIP at day 7 of mechanical ventilation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Respiratory Muscles
Not yet recruiting
Home-Based Respiratory Muscle Training and Aerobic Exercise Programs to Improve Lung Health in Current and Former Cigarette Smokers
Lung Carcinoma
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
Active, not recruiting
Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
Coronary Artery Bypass Graft (CABG)
RecruitingObservational study
Study of the Disease Process of Lymphangioleiomyomatosis
Lung Disease, Pneumothorax
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Schepens, M.D., Ph.D. study director
PICU staff member
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of nasogastric balloon in people with Respiratory Muscles and Respiration, Artificial, run by University Hospital, Antwerp at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vertongen (+323 821 44 04, icu-research@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tidal esophageal pressure swing (∆Pes) - D1 (time frame: ∆Pes (average over 1 minute recording) at day 1 of mechanical ventilation). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.