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CompletedNCT03092557Updated Oct 30, 2017

A New Ultrasonographic Tool to Assess Regional Pulmonary Strain

An interventional study of Determination of local pleural strain 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 2017-10-30.

Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study is designed to assess the feasibility of the measurement of local pleural strain at 4 different anatomical sites.

The secondary objectives of the study are:

  • To assess intra- and inter-observer variability in the measurement of local pleural strain
  • To identify the strain parameters demonstrating the most clinically relevant and the most significant correlation with a change in tidal volume

Hypothesis: The analysis of lung ultrasonographic sequences using speckle-tracking allows the determination of local pleural strain in 4 predetermined pulmonary areas.

Read the detailed description

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 assess the feasibility of the measurement of local pleural strain in 4 predetermined pulmonary areas using ultrasonographic imaging.

Following the induction of general anesthesia and the patient's intubation, 4 different tidal volumes of 6 ml/kg, 8ml/kg, 10 ml/kg and 12 ml/kg will be studied. For each volume, images of the pleura will be made at 4 predetermined areas. The sites to be studied will be: the 4th intercostal space at the mid-clavicular line (left and right side), the 7th intercostal space at the posterior axillary line (left and right side). For each tidal volume, 3 consecutive respiratory cycles at each site will be recorded for subsequent analysis.

To assess intra- and inter-observer variability, for the 10 ml/kg tidal volume only, the examination will be immediately repeated by a second observer at the 4 predetermined sites. The first observer will also return to repeat the examination at the same sites.

Mechanical ventilation parameters will be standardized throughout the study as follows: volume-controlled ventilation, respiratory rate at 12 breaths per minute adjusted to obtain expired carbon dioxide (CO2) between 30 and 40 mm Hg, initial inspired oxygen fraction of 40% adjusted between 40% and 80% to obtain oxygen saturation ≥ 92% and positive end-expiratory pressure at 6 cm H2O. In the event of a desaturation (saturation inferior to 90%) despite an increase in inspired oxygen fraction, the study will be stopped and adjustments of mechanical ventilation parameters will be left to the attending anesthesiologist's discretion.

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 ribs and pleura with the pointer towards the participant's head. Depth will be adjusted in order to have the pleural line in the center of the screen. The beam's focal zone will be positioned at the level of the pleural line. A 12 megahertz (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. An experienced technician will visually validate the speckle-tracking.

02

Conditions studied

  • Ventilator-Induced Lung Injury
  • Mechanical Ventilation Complication
03

In context

Lung Injury

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with presumed healthy lungs undergoing elective surgery under general anesthesia requiring neuromuscular blocking agents and orotracheal intubation

Exclusion criteria

Exclusion Criteria:

  • Previous thoracic procedure (chest tube, thoracotomy, thoracoscopy)
  • Pre-existing pulmonary disease (asthma, chronic obstructive pulmonary disease, lung fibrosis)
  • Active or previous history of smoking
  • Need for supplemental oxygen
  • Abnormal pulmonary function tests (when available)
  • Obesity (Body Mass Index superior to 30 kg/m2)
  • Functional capacity inferior to 4 metabolic equivalent of task (METs)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Determination of local pleural strain

    Patients will receive four different tidal volumes in random order (6 mL/kg, 8 mL/kg, 10 mL/kg, 12 mL/kg).

    Other: Determination of local pleural strain

Interventions

  • OtherDetermination of local pleural strain

    For each tidal volume, the local pleural strain will be determined over three consecutive respiratory cycles at four predetermined sites using lung ultrasonography.

06

What researchers measure

Primary outcomes

  1. Feasibility of the measurement of local pleural strain using ultrasonography

    Proportion of successfully analyzed lung ultrasonographic clips

    Time frame: At the end of study on Day 1

Secondary outcomes

  1. Intra-observer variability

    Agreement and bias will be calculated according to Bland and Altman

    Time frame: At the end of study on Day 1

  2. Inter-observer variability

    Agreement and bias will be calculated according to Bland and Altman

    Time frame: At the end of study on Day 1

  3. Maximal axial deformation

    Increase from baseline in percentage

    Time frame: At the end of study on Day 1

  4. Maximal lateral deformation

    Increase from baseline in percentage

    Time frame: At the end of study on Day 1

  5. Mean magnitude of shear deformation

    Increase from baseline in percentage

    Time frame: At the end of study on Day 1

  6. Cumulative axial translation

    Difference from baseline in millimeters

    Time frame: At the end of study on Day 1

  7. Cumulative lateral translation

    Difference from baseline in millimeters

    Time frame: At the end of study on Day 1

07

Study locations

1 site
  • Centre Hospitalier de l'Université de Montréal (CHUM)
    Montreal, Quebec H2L 4M1, Canada
08

References and documents

Publications

  • Girard M, Roy Cardinal MH, Chasse M, Garneau S, Cavayas YA, Cloutier G, Denault AY. Regional pleural strain measurements during mechanical ventilation using ultrasound elastography: A randomized, crossover, proof of concept physiologic study. Front Med (Lausanne). 2022 Sep 15;9:935482. doi: 10.3389/fmed.2022.935482. eCollection 2022. PubMed 36186794 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03092557
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Responsible party
Sponsor
First posted
Mar 28, 2017
Start date
Jul 24, 2017
Primary completion
Oct 26, 2017
Completion
Oct 26, 2017
Last update
Oct 30, 2017

Study contacts

Martin Girard, MD, FRCPC
principal investigator · Centre hospitalier de l'Université de Montréal (CHUM)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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