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

NCT04194346 | Completed

• 1 other identifier: 19.251
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (1)

• Average Von Mises

  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 Outcomes (4)

• Sum of the ranges of cumulated absolute axial and cumulated absolute lateral deformation

  At the end of the study on Day 1

• Range of cumulated absolute lateral deformation

  At the end of the study on Day 1

• Cumulated absolute lateral translation

  At the end of the study on Day 1

• Maximal echo intensity change

  At the end of the study on Day 1

Study Arms (1)

Determination of local pleural strain

EXPERIMENTAL

The average Von Mises coefficient will be calculated for each recorded ultrasound loop using a non-invasive vascular elastography platform.

Procedure: Lung ultrasound

Interventions

Lung ultrasound PROCEDURE

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.

Determination of local pleural strain

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: An equal number of men and women will be recruited.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers (20 men/20 women)
• years old and over
• Functional capacity superior to 4 METs (metabolic equivalent of task)

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

Study Officials

• Martin Girard, MD, FRCPC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, interventional

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 11, 2019
• Study Start: March 1, 2023
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)