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

NCT03817918 | Completed

• 1 other identifier: 18.304
• Study Type: interventional
• Target: 10
• 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 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.

Conditions

Ventilator-Induced Lung Injury; Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Average absolute lateral deformation

  At the end of the study on Day 1

• Cumulated range of absolute lateral deformation

  At the end of the study on Day 1

• Average absolute lateral shift

  At the end of the study on Day 1

• Cumulated range of absolute lateral shift

  At the end of the study on Day 1

• Average von mises

  At the end of the study on Day 1

Study Arms (1)

Determination of local pleural strain

EXPERIMENTAL

The local pleural strain will be determined over three consecutive respiratory cycles using lung ultrasonography

Procedure: Lung ultrasonography

Interventions

Lung ultrasonography PROCEDURE

Patients undergoing thoracic surgery under general anesthesia using one-lung ventilation will have lung ultrasonography at 2 predetermined sites at four different time points

Determination of local pleural strain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing thoracic surgery in lateral position requiring one-lung ventilation

You may not qualify if:

• 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

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

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

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, cohort study

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 28, 2019
• Study Start: March 21, 2019
• Primary Completion: May 17, 2019
• Study Completion: May 17, 2019
• Last Updated: June 19, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)