A New Ultrasonographic Tool to Assess Pulmonary Strain in Patients Under One-lung Ventilation. (STRAIN-VUP)
Primary Purpose
Ventilator-Induced Lung Injury, Mechanical Ventilation Complication
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lung ultrasonography
Sponsored by
About this trial
This is an interventional other trial for Ventilator-Induced Lung Injury
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing thoracic surgery in lateral position requiring one-lung ventilation
Exclusion Criteria:
- Obesity (Body Mass Index superior to 30 kg/m2)
- Emergency surgery
- Previous thoracic procedure (chest tube, thoracotomy, thoracoscopy)
- Previous participation to the study
- Patient refusal
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
The local pleural strain will be determined over three consecutive respiratory cycles using lung ultrasonography
Outcomes
Primary Outcome Measures
Feasibility of the measurement of local pleural strain using ultrasonography
Proportion of successfully analyzed lung ultrasonographic clips
Secondary Outcome Measures
Average absolute lateral deformation
Change in percentage from baseline expiratory values
Cumulated range of absolute lateral deformation
Change in percentage from baseline expiratory values
Average absolute lateral shift
Change in percentage from baseline expiratory values
Cumulated range of absolute lateral shift
Change in percentage from baseline expiratory values
Average von mises
Change in percentage from baseline expiratory values
Full Information
NCT ID
NCT03817918
First Posted
January 24, 2019
Last Updated
June 18, 2019
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
1. Study Identification
Unique Protocol Identification Number
NCT03817918
Brief Title
A New Ultrasonographic Tool to Assess Pulmonary Strain in Patients Under One-lung Ventilation.
Acronym
STRAIN-VUP
Official Title
A Pilot Study of a New Ultrasonographic Tool to Assess Regional Pulmonary Strain in Patients Under General Anesthesia Using One-lung Ventilation.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 21, 2019 (Actual)
Primary Completion Date
May 17, 2019 (Actual)
Study Completion Date
May 17, 2019 (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
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 create a small dataset of local pleural strain values assessed at predetermined pulmonary areas using ultrasound imaging in patients undergoing thoracic surgery requiring one-lung ventilation. This dataset will be used to help plan larger scale studies.
Detailed Description
At four different time points during thoracic surgery, images of the pleura of the dependent lung will be made at 2 predetermined areas. The images will be made: after induction (tidal volume of 10 mL/kg), during two-lung ventilation (tidal volume of 10 mL/kg) and during one-lung ventilation (tidal volume of 10 mL/kg and 5 mL/kg). The sites to be studied will be: the 3rd intercostal space at the mid-clavicular line (dependent lung), the 8th intercostal space at the posterior axillary line (dependent lung). Three consecutive respiratory cycles at each site will be recorded for subsequent analysis.
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 pleura with the pointer towards the participant's head. A depth of 4 cm will be used and adjusted in order to have the pleural line located between the center and the three-quarts of the screen. The beam's focal zone will be positioned at the level of the pleural line. A 12 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. The principal investigator or a co-investigator 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
The local pleural strain will be determined over three consecutive respiratory cycles using lung ultrasonography
Intervention Type
Procedure
Intervention Name(s)
Lung ultrasonography
Intervention Description
Patients undergoing thoracic surgery under general anesthesia using one-lung ventilation will have lung ultrasonography at 2 predetermined sites at four different time points
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 the study on Day 1
Secondary Outcome Measure Information:
Title
Average absolute lateral deformation
Description
Change in percentage from baseline expiratory values
Time Frame
At the end of the study on Day 1
Title
Cumulated range of absolute lateral deformation
Description
Change in percentage from baseline expiratory values
Time Frame
At the end of the study on Day 1
Title
Average absolute lateral shift
Description
Change in percentage from baseline expiratory values
Time Frame
At the end of the study on Day 1
Title
Cumulated range of absolute lateral shift
Description
Change in percentage from baseline expiratory values
Time Frame
At the end of the study on Day 1
Title
Average von mises
Description
Change in percentage from baseline expiratory values
Time Frame
At the end of the study on Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing thoracic surgery in lateral position requiring one-lung ventilation
Exclusion Criteria:
Obesity (Body Mass Index superior to 30 kg/m2)
Emergency surgery
Previous thoracic procedure (chest tube, thoracotomy, thoracoscopy)
Previous participation to the study
Patient refusal
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
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A New Ultrasonographic Tool to Assess Pulmonary Strain in Patients Under One-lung Ventilation.
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