A New Ultrasonographic Tool to Assess Pulmonary Strain in the ICU

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Ventilator-Induced Lung Injury; Mechanical Ventilation Complication
• Intervention / Treatment: Procedure: Lung ultrasonography

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.

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: Martin Girard, MD,FRCPC; Phone Number: 12131 514-890-8000; Email: martin.girard@umontreal.ca
• Study Contact Backup: Name: Julie Desroches, PhD; Phone Number: 12171 514-890-8000; Email: julie.desroches.chum@ssss.gouv.qc.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2X 3E4
      • Recruiting
      • Centre Hospitalier de l'Universite de Montreal (CHUM)
      • Contact: Martin Girard, MD,FRCPC; Phone Number: 12131 514-890-8000; Email: martin.girard@umontreal.ca
      • Sub-Investigator: Sébastien Cipolla, MD
      • Sub-Investigator: Guy Cloutier, Ing, PhD
      • Sub-Investigator: Michaël Chassé, MD,FRCPC
      • Sub-Investigator: André Denault, MD,FRCPC
      • Contact: Julie Desroches, PhD; Phone Number: 12171 514-890-8000; Email: julie.desroches.chum@ssss.gouv.qc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average absolute lateral deformation	Change in percentage from baseline expiratory value	At the end of study on Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulated range of absolute lateral deformation	Change in percentage from baseline expiratory value	At the end of study on Day 1
Average absolute axial deformation	Change in percentage from baseline expiratory value	At the end of study on Day 1
Cumulated range of absolute axial deformation	Change in percentage from baseline expiratory value	At the end of study on Day 1
Average von mises	Change in percentage from baseline expiratory value	At the end of study on Day 1
Average absolute lateral shear	Change in percentage from baseline expiratory value	At the end of study on Day 1
Cumulated range of absolute lateral shear	Change in percentage from baseline expiratory value	At the end of study on Day 1

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Martin Girard, MD,FRCPC, Centre Hospitalier de l'Universite de Montreal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2018
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: January 15, 2018
• First Submitted That Met QC Criteria: January 15, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 12, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Injury; Ventilator-Induced Lung Injury
• Other Study ID Numbers: 17.277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No