Determination of Normal Values of Regional Pulmonary Strain Using a New Ultrasonographic Tool in Healthy Volunteers

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM) (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04194346
Collaborator
(none)
20
1
1
5
4

Study Details

Study Description

Brief Summary

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 5 inspired volumes at 4 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 4 predetermined lung areas for a set of 5 inspired volumes in healthy volunteers.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Lung ultrasound
N/A

Detailed Description

Participants will have their functional residual capacity (FRC) measured by a nitrogen dilution technique. Subsequently, they will be instructed to breathe 5 different inspired volumes (6, 8, 10, 12 and 15 ml/kg predicted body weight). Tidal volumes will be measured using a spirometer. For each inspired volume, 3 respiratory cycles will be recorded at four predetermined anatomic sites: left and right 3rd intercoastal space at the mid-clavicular line, and left and right 8th intercoastal space at the posterior axillary line. For each image, the probe will be oriented perpendicularly to the ribs. A research, non-commercially available, non-invasive vascular elastography platform will be used to calculate the various strain parameters for all of the recorded cineloops. For each recorded clip, an experienced lung ultrasonographer will segment the pleura on a single reference image. From this image, an algorithm will define a region of interest which will be tracked throughout the rest of the images of the video sequence. Finally, the algorithm will calculate the various components of pleural strain.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective, interventionalProspective, interventional
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Determination of Normal Values of Regional Pulmonary Strain Using a New Ultrasonographic Tool in Healthy Volunteers
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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.

Procedure: Lung ultrasound
Healthy volunteers will have lung ultrasonography at 4 predetermined sites for a set of 5 inspired volumes. For each volume, 3 respiratory cycles will be recorded.

Outcome Measures

Primary Outcome Measures

  1. Average Von Mises [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.

Secondary Outcome Measures

  1. Sum of the ranges of cumulated absolute axial and cumulated absolute lateral deformation [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.

  2. Range of cumulated absolute lateral deformation [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.

  3. Cumulated absolute lateral translation [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.

  4. Maximal echo intensity change [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy volunteers (10 men/10 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier de l'Université de Montréal (CHUM) Montréal Quebec Canada H2X 3E4

Sponsors and Collaborators

  • Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

  • Principal Investigator: Martin Girard, MD, FRCPC, Centre hospitalier de l'Université de Montréal (CHUM)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT04194346
Other Study ID Numbers:
  • 19.251
First Posted:
Dec 11, 2019
Last Update Posted:
May 31, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 31, 2022