ClinicalTrials.gg
RecruitingNCT03405779Updated Sep 18, 2025

A New Ultrasonographic Tool to Assess Pulmonary Strain in the ICU

An observational study in Mechanical Ventilation Complication and Ventilator-Induced Lung Injury, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-18.

Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2026, 10 months ago, but the record still lists the study as recruiting.
  • Started Mar 2018; still recruiting 8 years 8 months later.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 15 studies in Ventilator-Induced Lung Injury with a site in Canada — 4 open to participants now, 5 under way, none of them phase 3. Ventilator-Induced Lung Injury · Canada.

Started
2018
the only one that year
Observational
5 of 15
2 open now
Registered
9th of 15
by date
Lead sponsor
4 of 15
Centre hospitalier de l'Université de Montréal (CHUM)

Among the 15 studies in Ventilator-Induced Lung Injury with a site in Canada, this one is the only one that started in 2018, is one of 5 observational ones, and was the 9th registered.

Ventilator-Induced Lung Injury

121 studies on the registry are indexed under Ventilator-Induced Lung Injury; 39 are open to participants now.

Browse Ventilator-Induced Lung Injury studies →

Open to participants now

4 of the 15 studies in Ventilator-Induced Lung Injury with a site in Canada are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 22 Ventilator-Induced Lung Injury studies recruiting now, 15 (68%) set no upper age limit and 5 (23%) stop at 75 or younger; 5 take children under 18; 1 takes healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 15 studies in Ventilator-Induced Lung Injury with a site in Canada, or all of them as a file.
02

Study summary

The primary objective of the study is to create a small dataset of regional pulmonary strain values in patients suffering from pulmonary diseases under mechanical ventilation in an intensive care setting.

Hypothesis: The analysis of lung ultrasonographic sequences using speckle-tracking allows the determination of local pleural strain in 4 predetermined pulmonary areas in mechanically ventilated patients suffering from pulmonary diseases.

Read the detailed description

Mechanical ventilation is frequently used in the intensive care settings. Although essential in many cases, mechanical ventilation can be responsible for ventilator-induced lung injury (VILI). The relationship between mechanical ventilation and VILI has been clearly demonstrated in animals and is highly suspected in humans. The putative mechanism responsible for VILI is excessive pulmonary strain or overdistension. Frequently observed in mechanically ventilated patients, the presence of severe pulmonary disease can increase the risk of overdistension. The development of a tool allowing early detection of pulmonary overdistension would represent a great asset in the prevention of VILI by allowing safer adjustments of mechanical ventilation parameters. Ultrasonographic imaging is a non-radiant, non-invasive technique already available in the intensive care setting. Presently used for cardiac strain measurements, ultrasonography is a promising avenue to assess pulmonary strain.

This pilot study will aim to create a small dataset of local pleural strain values assessed in 4 predetermined pulmonary areas using ultrasonographic imaging in mechanically ventilated patients suffering from pulmonary diseases in the intensive care setting. This dataset will be used to help plan larger scale studies.

Methods:

Intensive care patients under mechanical ventilation will undergo imaging of the pleura at 4 predetermined areas. The sites to be studied will be: the 3rd intercostal space at the mid-clavicular line (left and right side), the 8th intercostal space at the posterior axillary line (left and right side). Three consecutive respiratory cycles at each site will be recorded for subsequent analysis.

Lung ultrasonography will be performed by the principal investigator and a co-investigator using a Terason (Teratech Corporation, Burlington, MA) device and a 12L5 linear ultrasound probe. For each image, the probe will be oriented perpendicularly to the pleura with the pointer towards the participant's head. The beam's focal zone will be positioned at the level of the pleural line.

Using a reference ultrasonographic image, an experienced lung ultrasonographer will segment the pleura. From this image, an algorithm will define a region of interest which will be followed throughout the rest of the images of the video sequence. Thereafter, the algorithm will calculate the various components of pulmonary strain. An experienced technician will visually validate the algorithm's tracking.

03

Conditions studied

  • Mechanical Ventilation Complication
  • Ventilator-Induced Lung Injury
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult Intensive care patients under mechanical ventilation suffering from a pulmonary disease.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult intensive care patients under mechanical ventilation suffering from a pulmonary disease with a static lung compliance of less than 40 mL/cm H2O.

Exclusion criteria

Exclusion Criteria:

  • Obesity ( superior to 30 kg/m2)
  • Previous thoracic procedure (chest tube, thoracotomy, thoracoscopy)
  • Intra-abdominal pressure inferior to 15 mm Hg (if available)
  • Previous participation to the study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No

Interventions

  • ProcedureLung ultrasonography

    Mechanically ventilated patients suffering from pulmonary diseases will undergo a lung ultrasonography during their stay in the intensive care unit (ICU)

06

What researchers measure

Primary outcomes

  1. Average absolute lateral deformation

    Change in percentage from baseline expiratory value

    Time frame: At the end of study on Day 1

Secondary outcomes

  1. Cumulated range of absolute lateral deformation

    Change in percentage from baseline expiratory value

    Time frame: At the end of study on Day 1

  2. Average absolute axial deformation

    Change in percentage from baseline expiratory value

    Time frame: At the end of study on Day 1

  3. Cumulated range of absolute axial deformation

    Change in percentage from baseline expiratory value

    Time frame: At the end of study on Day 1

  4. Average von mises

    Change in percentage from baseline expiratory value

    Time frame: At the end of study on Day 1

  5. Average absolute lateral shear

    Change in percentage from baseline expiratory value

    Time frame: At the end of study on Day 1

  6. Cumulated range of absolute lateral shear

    Change in percentage from baseline expiratory value

    Time frame: At the end of study on Day 1

07

Study locations

1 of 1 sites recruiting
  • Centre Hospitalier de l'Université de Montréal (CHUM)
    Montreal, Quebec H2X 3E4, Canada
    Recruiting
    • Martin Girard, MD,FRCPC · Contactmartin.girard@umontreal.ca · 514-890-8000
    • Julie Desroches, PhD · Contactjulie.desroches.chum@ssss.gouv.qc.ca · 514-890-8000
    • Sébastien Cipolla, MD · Sub investigator
    • Guy Cloutier, Ing, PhD · Sub investigator
    • Michaël Chassé, MD,FRCPC · Sub investigator
    • André Denault, MD,FRCPC · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2018 (actual). Primary completion is estimated for Jan 2026, 93 months after the start.

Of 30 observational studies under Ventilator-Induced Lung Injury, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12. This study's planned 93 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 15, 2018
First posted
Jan 23, 2018
StartActual
Mar 12, 2018
Primary completionEst.
Jan 1, 2026
CompletionEst.
Feb 1, 2026
Last update
Sep 18, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03405779
Responsible party
Sponsor
First posted
Jan 23, 2018
Start date
Mar 12, 2018
Primary completion
Jan 1, 2026 (estimated)
Completion
Feb 1, 2026 (estimated)
Last update
Sep 18, 2025

Study contacts

Martin Girard, MD,FRCPC
Contact
martin.girard@umontreal.ca
514-890-8000 ext. 12131
Julie Desroches, PhD
Contact
julie.desroches.chum@ssss.gouv.qc.ca
514-890-8000 ext. 12171
Martin Girard, MD,FRCPC
principal investigator · Centre hospitalier de l'Université de Montréal (CHUM)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion