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Clinical Trials/NCT03405779
NCT03405779RecruitingNot 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 enrollmentStarted: March 12, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
10
Locations
1
Primary Endpoint
Average absolute lateral deformation

Study 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

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

Study Sites (1)

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