An interventional study of Lung ultrasonography in Ventilator-Induced Lung Injury and Mechanical Ventilation Complication, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-19.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Other
Mechanical ventilation is frequently used in the operating room and 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 a severe pre-existing 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. Already 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 at predetermined pulmonary areas using ultrasound imaging in patients undergoing thoracic surgery requiring one-lung ventilation. This dataset will be used to help plan larger scale studies.
At four different time points during thoracic surgery, images of the pleura of the dependent lung will be made at 2 predetermined areas. The images will be made: after induction (tidal volume of 10 mL/kg), during two-lung ventilation (tidal volume of 10 mL/kg) and during one-lung ventilation (tidal volume of 10 mL/kg and 5 mL/kg). The sites to be studied will be: the 3rd intercostal space at the mid-clavicular line (dependent lung), the 8th intercostal space at the posterior axillary line (dependent lung). 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. A depth of 4 cm will be used and adjusted in order to have the pleural line located between the center and the three-quarts of the screen. The beam's focal zone will be positioned at the level of the pleural line. A 12 MHz frequency will be used.
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 in relation to tidal volume. The principal investigator or a co-investigator will visually validate the speckle-tracking.
399 studies on the registry are indexed under Lung Injury; 50 are open to participants now.
This study's enrollment of 10 is below the median of 53 across 239 interventional studies indexed under Lung Injury.
Browse Lung Injury studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 370 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The local pleural strain will be determined over three consecutive respiratory cycles using lung ultrasonography
Procedure: Lung ultrasonography
Patients undergoing thoracic surgery under general anesthesia using one-lung ventilation will have lung ultrasonography at 2 predetermined sites at four different time points
Feasibility of the measurement of local pleural strain using ultrasonography
Proportion of successfully analyzed lung ultrasonographic clips
Time frame: At the end of the study on Day 1
Average absolute lateral deformation
Change in percentage from baseline expiratory values
Time frame: At the end of the study on Day 1
Cumulated range of absolute lateral deformation
Change in percentage from baseline expiratory values
Time frame: At the end of the study on Day 1
Average absolute lateral shift
Change in percentage from baseline expiratory values
Time frame: At the end of the study on Day 1
Cumulated range of absolute lateral shift
Change in percentage from baseline expiratory values
Time frame: At the end of the study on Day 1
Average von mises
Change in percentage from baseline expiratory values
Time frame: At the end of the study on Day 1
Plan to share: No
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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Centre hospitalier de l'Université de Montréal (CHUM)