Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03405779

A New Ultrasonographic Tool to Assess Pulmonary Strain in the ICU

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location status: Recruiting

Location contact

André Denault, MD,FRCPC

SUB_INVESTIGATOR

Guy Cloutier, Ing, PhD

SUB_INVESTIGATOR

Julie Desroches, PhD

CONTACT

[email protected]

514-890-8000 ext. 12171

Martin Girard, MD,FRCPC

CONTACT

[email protected]

514-890-8000 ext. 12131

Michaël Chassé, MD,FRCPC

SUB_INVESTIGATOR

Sébastien Cipolla, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Lung ultrasonography

Procedure

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

Primary outcomes

  1. Average absolute lateral deformation

    Time frame: At the end of study on Day 1

    Change in percentage from baseline expiratory value

Secondary outcomes

  1. Cumulated range of absolute lateral deformation

    Time frame: At the end of study on Day 1

    Change in percentage from baseline expiratory value

  2. Average absolute axial deformation

    Time frame: At the end of study on Day 1

    Change in percentage from baseline expiratory value

  3. Cumulated range of absolute axial deformation

    Time frame: At the end of study on Day 1

    Change in percentage from baseline expiratory value

  4. Average von mises

    Time frame: At the end of study on Day 1

    Change in percentage from baseline expiratory value

  5. Average absolute lateral shear

    Time frame: At the end of study on Day 1

    Change in percentage from baseline expiratory value

  6. Cumulated range of absolute lateral shear

    Time frame: At the end of study on Day 1

    Change in percentage from baseline expiratory value

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Desroches, PhD

CONTACT

[email protected]

514-890-8000 ext. 12171

Martin Girard, MD,FRCPC

CONTACT

[email protected]

514-890-8000 ext. 12131

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

A Pilot Study of a New Ultrasonographic Tool to Assess Regional Pulmonary Strain in Mechanically Ventilated Patients Suffering From Pulmonary Diseases in an Intensive Care Setting.

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2018
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.