- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03817918
A New Ultrasonographic Tool to Assess Pulmonary Strain in Patients Under One-lung Ventilation. (STRAIN-VUP)
A Pilot Study of a New Ultrasonographic Tool to Assess Regional Pulmonary Strain in Patients Under General Anesthesia Using One-lung Ventilation.
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H2X 3E4
- Centre hospitalier de l'Université de Montréal (CHUM)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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 local pleural strain will be determined over three consecutive respiratory cycles using lung ultrasonography
|
Patients undergoing thoracic surgery under general anesthesia using one-lung ventilation will have lung ultrasonography at 2 predetermined sites at four different time points
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of the measurement of local pleural strain using ultrasonography
Time Frame: At the end of the study on Day 1
|
Proportion of successfully analyzed lung ultrasonographic clips
|
At the end of the study on Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average absolute lateral deformation
Time Frame: At the end of the study on Day 1
|
Change in percentage from baseline expiratory values
|
At the end of the study on Day 1
|
Cumulated range of absolute lateral deformation
Time Frame: At the end of the study on Day 1
|
Change in percentage from baseline expiratory values
|
At the end of the study on Day 1
|
Average absolute lateral shift
Time Frame: At the end of the study on Day 1
|
Change in percentage from baseline expiratory values
|
At the end of the study on Day 1
|
Cumulated range of absolute lateral shift
Time Frame: At the end of the study on Day 1
|
Change in percentage from baseline expiratory values
|
At the end of the study on Day 1
|
Average von mises
Time Frame: At the end of the study on Day 1
|
Change in percentage from baseline expiratory values
|
At the end of the study on Day 1
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18.304
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.
Clinical Trials on Ventilator-Induced Lung Injury
-
Capital Medical UniversityBeijing Tiantan HospitalCompleted
-
Ayse UlgeyNot yet recruitingVentilator-induced Lung InjuryTurkey
-
Lungpacer Medical Inc.CompletedVentilator Induced Lung InjuryParaguay
-
Lingling DingNot yet recruitingElectroacupuncture | Lung Injury, Ventilator Induced
-
Shanghai Zhongshan HospitalUnknownMechanical Ventilation | Transpulmonary Pressure | Ventilator-induced Lung InjuryChina
-
Kocaeli UniversityCompletedVentilator-Induced Lung Injury | Ventilator Adverse Event | Lung Injury, AcuteTurkey
-
Gazi UniversityCompletedVentilator Induced Lung Injury | Respiratory Distress, NewbornTurkey
-
E-DA HospitalCompletedVentilator-Induced Lung Injury | One-lung Ventilation | Lung VentilatorTaiwan
-
University of Sao PauloInCor Heart InstituteCompletedAcute Lung Injury | Cardiac Disease | Ventilator Induced Lung InjuryBrazil
-
University Hospital OstravaRecruitingARDS | Lung Injury, Ventilator InducedCzechia
Clinical Trials on Lung ultrasonography
-
Rajiv Gandhi Cancer Institute & Research Center...Completed
-
Assiut UniversityRecruitingCOVID-19 PneumoniaEgypt
-
Bursa Yüksek İhtisas Education and Research HospitalCompleted
-
University Hospital, CaenCompletedUltrasonography | Education | General PracticeFrance
-
Centre hospitalier de l'Université de Montréal...RecruitingVentilator-Induced Lung Injury | Mechanical Ventilation ComplicationCanada
-
University Hospital, CaenCompletedLower Resp Tract Infection | Ultrasound Therapy; ComplicationsFrance
-
Kırıkkale UniversityEnrolling by invitationSuspected Damage to Fetus From Other Disease in the Mother, Affecting Management of Mother, With Delivery | Patient Death or Serious Disability Associated With A Haemolytic Reaction Due to the Administration of ABO-Incompatible Blood or Blood ProductsTurkey
-
South Egypt Cancer InstituteRecruiting
-
Azienda Sanitaria-Universitaria Integrata di UdineMaastricht UniversityUnknown
-
Seoul National University HospitalRecruitingPulmonary ComplicationKorea, Republic of