A New Ultrasonographic Tool to Assess Pulmonary Strain in the ICU

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM) (Other)
Overall Status
Recruiting
CT.gov ID
NCT03405779
Collaborator
(none)
10
1
54.7
0.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official 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.
Actual Study Start Date :
Mar 12, 2018
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Average absolute lateral deformation [At the end of study on Day 1]

    Change in percentage from baseline expiratory value

Secondary Outcome Measures

  1. Cumulated range of absolute lateral deformation [At the end of study on Day 1]

    Change in percentage from baseline expiratory value

  2. Average absolute axial deformation [At the end of study on Day 1]

    Change in percentage from baseline expiratory value

  3. Cumulated range of absolute axial deformation [At the end of study on Day 1]

    Change in percentage from baseline expiratory value

  4. Average von mises [At the end of study on Day 1]

    Change in percentage from baseline expiratory value

  5. Average absolute lateral shear [At the end of study on Day 1]

    Change in percentage from baseline expiratory value

  6. Cumulated range of absolute lateral shear [At the end of study on Day 1]

    Change in percentage from baseline expiratory value

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier de l'Université de Montréal (CHUM) Montréal Quebec Canada H2X 3E4

Sponsors and Collaborators

  • Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

  • Principal Investigator: Martin Girard, MD,FRCPC, Centre hospitalier de l'Université de Montréal (CHUM)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT03405779
Other Study ID Numbers:
  • 17.277
First Posted:
Jan 23, 2018
Last Update Posted:
Jun 28, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 28, 2022