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Clinical Trials/NCT03405779
NCT03405779
Recruiting
Not Applicable

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.

Centre hospitalier de l'Université de Montréal (CHUM)1 site in 1 country10 target enrollmentMarch 12, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mechanical Ventilation Complication
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Enrollment
10
Locations
1
Primary Endpoint
Average absolute lateral deformation
Status
Recruiting
Last Updated
7 months ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
March 12, 2018
End Date
February 1, 2026
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Average absolute lateral deformation

Time Frame: At the end of study on Day 1

Change in percentage from baseline expiratory value

Secondary Outcomes

  • Average absolute axial deformation(At the end of study on Day 1)
  • Cumulated range of absolute lateral deformation(At the end of study on Day 1)
  • Cumulated range of absolute axial deformation(At the end of study on Day 1)
  • Average von mises(At the end of study on Day 1)
  • Average absolute lateral shear(At the end of study on Day 1)
  • Cumulated range of absolute lateral shear(At the end of study on Day 1)

Study Sites (1)

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