A New Ultrasonographic Tool to Assess Pulmonary Strain in Patients Under One-lung Ventilation.

Mechanical Ventilation Complication Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03817918
• Other study ID #: 18.304
• Status: Completed
• Phase: N/A
• Start date: March 21, 2019
• Est. completion date: May 17, 2019

Study information

• Verified date: June 2019
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 17, 2019
• Est. primary completion date: May 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Injury
• Mechanical Ventilation Complication
• Ventilator-Induced Lung Injury

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the measurement of local pleural strain using ultrasonography	Proportion of successfully analyzed lung ultrasonographic clips	At the end of the study on Day 1
Secondary	Average absolute lateral deformation	Change in percentage from baseline expiratory values	At the end of the study on Day 1
Secondary	Cumulated range of absolute lateral deformation	Change in percentage from baseline expiratory values	At the end of the study on Day 1
Secondary	Average absolute lateral shift	Change in percentage from baseline expiratory values	At the end of the study on Day 1
Secondary	Cumulated range of absolute lateral shift	Change in percentage from baseline expiratory values	At the end of the study on Day 1
Secondary	Average von mises	Change in percentage from baseline expiratory values	At the end of the study on Day 1