CClinicalTrials.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

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

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.

02

Conditions studied

  • Mechanical Ventilation Complication
  • Ventilator-Induced Lung Injury
03

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.

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 (Body Mass Index 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
04

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)

05

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

06

Study locations

1 of 1 sites recruiting
  • Centre Hospitalier de l'Université de Montréal (CHUM)
    Montreal, Quebec H2X 3E4, Canada
    • Martin Girard, MD,FRCPC · Contact · martin.girard@umontreal.ca · 514-890-8000
    • Julie Desroches, PhD · Contact · julie.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
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03405779
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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