A New Ultrasonographic Tool to Assess Regional Pulmonary Strain

NCT ID: NCT03092557

Last Updated: 2017-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-24
• Study Completion Date: 2017-10-26

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.

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 ribs and pleura with the pointer towards the participant's head. Depth will be adjusted in order to have the pleural line in the center of the screen. The beam's focal zone will be positioned at the level of the pleural line. A 12 megahertz (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. An experienced technician will visually validate the speckle-tracking.

Conditions

Ventilator-Induced Lung Injury; Mechanical Ventilation Complication

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Determination of local pleural strain

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

Group Type: EXPERIMENTAL

Determination of local pleural strain

Intervention Type: OTHER

For each tidal volume, the local pleural strain will be determined over three consecutive respiratory cycles at four predetermined sites using lung ultrasonography.

Interventions

Determination of local pleural strain

For each tidal volume, the local pleural strain will be determined over three consecutive respiratory cycles at four predetermined sites using lung ultrasonography.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Girard, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Countries

Canada

References

Girard M, Roy Cardinal MH, Chasse M, Garneau S, Cavayas YA, Cloutier G, Denault AY. Regional pleural strain measurements during mechanical ventilation using ultrasound elastography: A randomized, crossover, proof of concept physiologic study. Front Med (Lausanne). 2022 Sep 15;9:935482. doi: 10.3389/fmed.2022.935482. eCollection 2022.

Reference Type: DERIVED

PMID: 36186794 (View on PubMed)

Other Identifiers

16.386

Identifier Type: -

Identifier Source: org_study_id