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Clinical Trials/NCT03092557
NCT03092557CompletedNot Applicable

A Pilot Study of a New Ultrasonographic Tool to Assess Regional Pulmonary Strain in Patients Under General Anesthesia

Centre hospitalier de l'Université de Montréal (CHUM)2 sites in 1 country10 target enrollmentStarted: July 24, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
10
Locations
2
Primary Endpoint
Feasibility of the measurement of local pleural strain using ultrasonography

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

Determination of local pleural strain

Experimental

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

Intervention: Determination of local pleural strain (Other)

Outcomes

Primary Outcomes

Feasibility of the measurement of local pleural strain using ultrasonography

Time Frame: At the end of study on Day 1

Proportion of successfully analyzed lung ultrasonographic clips

Secondary Outcomes

  • Intra-observer variability(At the end of study on Day 1)
  • Maximal axial deformation(At the end of study on Day 1)
  • Cumulative axial translation(At the end of study on Day 1)
  • Cumulative lateral translation(At the end of study on Day 1)
  • Maximal lateral deformation(At the end of study on Day 1)
  • Mean magnitude of shear deformation(At the end of study on Day 1)
  • Inter-observer variability(At the end of study on Day 1)

Investigators

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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