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.
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
- Conditions the study is for
- Ventilator-Induced Lung Injury, Mechanical Ventilation Complication
- 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
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 group | Role | What they receive |
|---|---|---|
| Determination of local pleural strain | Experimental | Patients 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.
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)
Intra-observer variability
Agreement and bias will be calculated according to Bland and Altman
Measured: At the end of study on Day 1
Inter-observer variability
Agreement and bias will be calculated according to Bland and Altman
Measured: At the end of study on Day 1
Maximal axial deformation
Increase from baseline in percentage
Measured: At the end of study on Day 1
Maximal lateral deformation
Increase from baseline in percentage
Measured: At the end of study on Day 1
Mean magnitude of shear deformation
Increase from baseline in percentage
Measured: At the end of study on Day 1
Cumulative axial translation
Difference from baseline in millimeters
Measured: At the end of study on Day 1
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.
- First posted28 Mar 2017
- Study start24 Jul 2017
- Primary completion26 Oct 2017
- Study completion26 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilator-Induced Lung InjuryStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Girard, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a New Ultrasonographic Tool to Assess Regional Pulmonary Strain in Patients Under General Anesthesia
- ClinicalTrials.gov ID
- NCT03092557
- Acronym / sponsor ID
- 16.386
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 26 Oct 2017 (actual)
- Study completion
- 26 Oct 2017 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, interventional, cohort study
| Arm | Type | Receives |
|---|---|---|
| Determination of local pleural strain | Experimental | Other: Determination of local pleural strainPatients will receive four different tidal volumes in random order (6 mL/kg, 8 mL/kg, 10 mL/kg, 12 mL/kg). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with presumed healthy lungs undergoing elective surgery under general anesthesia requiring neuromuscular blocking agents and orotracheal intubation
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determination of local pleural strainFor each tidal volume, the local pleural strain will be determined over three consecutive respiratory cycles at four predetermined sites using lung ultrasonography. | Other | Determination of local pleural strain |
Primary outcome
Feasibility of the measurement of local pleural strain using ultrasonography
Time frame: At the end of study on Day 1
Proportion of successfully analyzed lung ultrasonographic clips
7 secondary outcomes
Intra-observer variability
Time frame: At the end of study on Day 1
Inter-observer variability
Time frame: At the end of study on Day 1
Maximal axial deformation
Time frame: At the end of study on Day 1
Maximal lateral deformation
Time frame: At the end of study on Day 1
Mean magnitude of shear deformation
Time frame: At the end of study on Day 1
Cumulative axial translation
Time frame: At the end of study on Day 1
Cumulative lateral translation
Time frame: At the end of study on Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
- Derived from this study: PubMed 36186794Girard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Girard, MD, FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
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.