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A New Ultrasonographic Tool to Assess Regional Pulmonary Strain

Primary Purpose

Ventilator-Induced Lung Injury, Mechanical Ventilation Complication

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Determination of local pleural strain
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ventilator-Induced Lung Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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
  • 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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Determination of local pleural strain

Arm Description

Patients will receive four different tidal volumes in random order (6 mL/kg, 8 mL/kg, 10 mL/kg, 12 mL/kg).

Outcomes

Primary Outcome Measures

Feasibility of the measurement of local pleural strain using ultrasonography
Proportion of successfully analyzed lung ultrasonographic clips

Secondary Outcome Measures

Intra-observer variability
Agreement and bias will be calculated according to Bland and Altman
Inter-observer variability
Agreement and bias will be calculated according to Bland and Altman
Maximal axial deformation
Increase from baseline in percentage
Maximal lateral deformation
Increase from baseline in percentage
Mean magnitude of shear deformation
Increase from baseline in percentage
Cumulative axial translation
Difference from baseline in millimeters
Cumulative lateral translation
Difference from baseline in millimeters

Full Information

First Posted
March 12, 2017
Last Updated
October 26, 2017
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT03092557
Brief Title
A New Ultrasonographic Tool to Assess Regional Pulmonary Strain
Official Title
A Pilot Study of a New Ultrasonographic Tool to Assess Regional Pulmonary Strain in Patients Under General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 24, 2017 (Actual)
Primary Completion Date
October 26, 2017 (Actual)
Study Completion Date
October 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator-Induced Lung Injury, Mechanical Ventilation Complication

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, interventional, cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Determination of local pleural strain
Arm Type
Experimental
Arm Description
Patients will receive four different tidal volumes in random order (6 mL/kg, 8 mL/kg, 10 mL/kg, 12 mL/kg).
Intervention Type
Other
Intervention Name(s)
Determination of local pleural strain
Intervention Description
For each tidal volume, the local pleural strain will be determined over three consecutive respiratory cycles at four predetermined sites using lung ultrasonography.
Primary Outcome Measure Information:
Title
Feasibility of the measurement of local pleural strain using ultrasonography
Description
Proportion of successfully analyzed lung ultrasonographic clips
Time Frame
At the end of study on Day 1
Secondary Outcome Measure Information:
Title
Intra-observer variability
Description
Agreement and bias will be calculated according to Bland and Altman
Time Frame
At the end of study on Day 1
Title
Inter-observer variability
Description
Agreement and bias will be calculated according to Bland and Altman
Time Frame
At the end of study on Day 1
Title
Maximal axial deformation
Description
Increase from baseline in percentage
Time Frame
At the end of study on Day 1
Title
Maximal lateral deformation
Description
Increase from baseline in percentage
Time Frame
At the end of study on Day 1
Title
Mean magnitude of shear deformation
Description
Increase from baseline in percentage
Time Frame
At the end of study on Day 1
Title
Cumulative axial translation
Description
Difference from baseline in millimeters
Time Frame
At the end of study on Day 1
Title
Cumulative lateral translation
Description
Difference from baseline in millimeters
Time Frame
At the end of study on Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with presumed healthy lungs undergoing elective surgery under general anesthesia requiring neuromuscular blocking agents and orotracheal intubation 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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Girard, MD, FRCPC
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36186794
Citation
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.
Results Reference
derived

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A New Ultrasonographic Tool to Assess Regional Pulmonary Strain

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