- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04194346
Determination of Normal Values of Regional Pulmonary Strain Using a New Ultrasonographic Tool in Healthy Volunteers (Strain)
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 study will aim to establish normal pleural strain values using ultrasonography in healthy volunteers.
Purpose: The primary objective is to calculate 95% confidence intervals in pleural strain for a set of 8 inspired volumes at 15 predetermined lung areas in healthy volunteers.
The secondary objectives of the study are:
- to modelize the relation between pleural strain and inspired volume
- to modelize the relation between pleural strain and global pulmonary volumetric strain
- to modelize the relation between pleural strain and maximal echo intensity change
- to compare the regional distribution pattern of pleural strain in healthy volunteers in dependent versus non-dependent areas.
Hypothesis: Elastography using the Lagrangian speckle model estimator based on optical flow allows the determination of normal mean values and 95% confidence intervals of pleural strain (average Von Mises coefficient) in 15 predetermined lung areas for a set of 8 inspired volumes in healthy volunteers.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Martin Girard, MD, FRCPC
- Phone Number: 12132 514-890-8000
- Email: martin.girard@umontreal.ca
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H2X 3E4
- Recruiting
- Centre hospitalier de l'Université de Montréal (CHUM)
-
Sub-Investigator:
- Guy Cloutier, Ing, PhD
-
Sub-Investigator:
- André Denault, MD, FRCPC
-
Principal Investigator:
- Martin Girard, MD, FRCPC
-
Sub-Investigator:
- Bruno-Pierre Dubé, MD, FRCPC
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Sub-Investigator:
- Michaël Chassé, MD, FRCPC
-
Contact:
- Julie Desroches, PhD
- Phone Number: 24542 514-890-8000
- Email: anesthesie.recherche.chum@ssss.gouv.qc.ca
-
Contact:
- Vicky Thiffault, RN, CCRP
- Phone Number: 24542 514-890-8000
- Email: anesthesie.recherche.chum@ssss.gouv.qc.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy volunteers (20 men/20 women)
- 18 years old and over
- Functional capacity superior to 4 METs (metabolic equivalent of task)
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
- Obesity (Body Mass Index superior to 30 kg/m2)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Determination of local pleural strain
The average Von Mises coefficient will be calculated for each recorded ultrasound loop using a non-invasive vascular elastography platform.
|
Healthy volunteers will have lung ultrasonography at 15 predetermined sites for a common volume continuum between 5 and 15 cc/kg.
For each volume, 3 respiratory cycles will be recorded.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average Von Mises
Time Frame: At the end of the study on Day 1
|
Three respiratory cycles will be analyzed using an elastography technique based on optical flow to calculate the average Von Mises coefficient.
The mean value will be retained.
|
At the end of the study on Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sum of the ranges of cumulated absolute axial and cumulated absolute lateral deformation
Time Frame: At the end of the study on Day 1
|
Three respiratory cycles will be analyzed using an elastography technique based on optical flow to calculate the sum of the ranges of cumulated absolute axial and cumulated absolute lateral deformation in percentage for each cycle.
The mean value will be retained.
|
At the end of the study on Day 1
|
Range of cumulated absolute lateral deformation
Time Frame: At the end of the study on Day 1
|
Three respiratory cycles will be analyzed using an elastography technique based on optical flow to calculate the range of cumulated absolute lateral deformation in percentage for each respiratory cycle.
The mean value will be retained.
|
At the end of the study on Day 1
|
Cumulated absolute lateral translation
Time Frame: At the end of the study on Day 1
|
Three respiratory cycles will be analyzed using an elastography technique based on optical flow to calculate the cumulated absolute lateral translation in millimeters for each respiratory cycle.
The mean value will be retained.
|
At the end of the study on Day 1
|
Maximal echo intensity change
Time Frame: At the end of the study on Day 1
|
Three respiratory cycles will be analyzed to calculate the maximal echo intensity change using an ordinal scale from 0 to 255.
The mean value will be retained.
|
At the end of the study on Day 1
|
Collaborators and Investigators
Investigators
- Principal Investigator: Martin Girard, MD, FRCPC, Centre hospitalier de l'Université de Montréal (CHUM)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 19.251
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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