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Ventilator-Induced Lung InjuryNCT03092557

A New Ultrasonographic Tool to Assess Regional Pulmonary Strain

A study testing Determination of local pleural strain in people with Ventilator-Induced Lung Injury and Mechanical Ventilation Complication, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Determination of local pleural strain
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteCanada
Study dates
24 Jul 2017to 26 Oct 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Centre Hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec, H2L 4M1

Other trials in Canada

About this study

Official title: A Pilot Study of a New Ultrasonographic Tool to Assess Regional Pulmonary Strain in Patients Under General Anesthesia

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.

Being tested
Determination of local pleural strain
Medical subject headings
Ventilator-Induced Lung Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Determination of local pleural strainOther

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

Study groups in NCT03092557
Study groupRoleWhat they receive
Determination of local pleural strainExperimentalPatients will receive four different tidal volumes in random order (6 mL/kg, 8 mL/kg, 10 mL/kg, 12 mL/kg).
Receives: Other: Determination of local pleural strain

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Proportion of successfully analyzed lung ultrasonographic clips

    Measured: At the end of study on Day 1

Secondary outcomes (7)
  1. Intra-observer variability

    Agreement and bias will be calculated according to Bland and Altman

    Measured: At the end of study on Day 1

  2. Inter-observer variability

    Agreement and bias will be calculated according to Bland and Altman

    Measured: At the end of study on Day 1

  3. Maximal axial deformation

    Increase from baseline in percentage

    Measured: At the end of study on Day 1

  4. Maximal lateral deformation

    Increase from baseline in percentage

    Measured: At the end of study on Day 1

  5. Mean magnitude of shear deformation

    Increase from baseline in percentage

    Measured: At the end of study on Day 1

  6. Cumulative axial translation

    Difference from baseline in millimeters

    Measured: At the end of study on Day 1

  7. Cumulative lateral translation

    Difference from baseline in millimeters

    Measured: At the end of study on Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2017
  2. Study start24 Jul 2017
  3. Primary completion26 Oct 2017
  4. Study completion26 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective, interventional, cohort study
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03092557
Sponsor's protocol ID
16.386
Status last verified
Oct 2017
First submitted
12 Mar 2017
Last updated
30 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Determination of local pleural strain in people with Ventilator-Induced Lung Injury and Mechanical Ventilation Complication, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the measurement of local pleural strain using ultrasonography (time frame: At the end of study on Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03092557, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2017.

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