Lung Ultrasound for Mechanical Ventilation Complication

(Strain Trial)

Recruiting at 1 trial location

Overseen By Martin Girard, MD, FRCPC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Pulmonary disease, Smoking, Obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance the safety of mechanical ventilation by using lung ultrasound to detect potential lung injuries early. It focuses on understanding normal lung stretch in healthy individuals, which could help prevent issues in those with lung diseases. The trial employs ultrasound, a safe and non-invasive tool, to measure lung strain (stretch) in different lung areas. Healthy individuals who have never smoked and have no lung diseases may be suitable candidates for this trial. As an unphased study, this trial offers a unique opportunity to contribute to advancing medical knowledge and improving future patient care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves healthy volunteers without pre-existing pulmonary conditions, it's possible that certain medications might be restricted. Please consult with the trial coordinators for specific guidance.

What prior data suggests that lung ultrasound is safe for assessing pleural strain?

Research shows that lung ultrasound is safe in medical settings. Studies have found it to be a non-invasive and radiation-free method, making it easy for patients to tolerate. No reports of serious side effects have emerged from using lung ultrasound, and it is already commonly used in intensive care units. It aids doctors in making better decisions about patient care, especially for those on breathing machines. Although lung ultrasound is not new, its ability to detect lung problems early is promising. This could lead to safer treatment changes for patients needing breathing support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using lung ultrasound for mechanical ventilation complications because it offers a non-invasive way to assess lung health. Unlike traditional methods that might involve more invasive procedures or radiation exposure, this approach uses ultrasound technology to visualize and evaluate the lungs safely. By calculating the Von Mises coefficient with a vascular elastography platform, this technique provides detailed insights into pleural strain, helping doctors make more informed decisions. This method could potentially lead to quicker, more accurate detection of complications, improving patient outcomes without the risks associated with current diagnostic techniques.

What evidence suggests that lung ultrasound is effective for detecting pulmonary overdistension?

Research has shown that lung ultrasound, the focus of this trial, serves as a helpful tool for managing patients on breathing machines. Studies indicate it can detect lung problems early, potentially preventing further damage. This non-invasive method is used in critical care to assess lung conditions without exposing patients to radiation. It effectively identifies lung issues. By providing real-time images, lung ultrasound aids doctors in making safer decisions about machine settings, potentially reducing complications such as ventilator-induced lung injury. ^{1 3 4 5 6}

Who Is on the Research Team?

Martin Girard, MD, FRCPC

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

This trial is for healthy volunteers aged 18 and over, with a good level of fitness (able to perform activities worth more than 4 METs). It's not suitable for those who've had chest surgeries, are obese (BMI over 30), have lung diseases like asthma or COPD, or are current/former smokers.

Inclusion Criteria

Functional capacity superior to 4 METs (metabolic equivalent of task)

I am a healthy volunteer.

Exclusion Criteria

My BMI is over 30.

I have had a previous chest surgery or procedure.

I have a lung condition like asthma, COPD, or fibrosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Measurement

Participants will have their functional residual capacity (FRC) measured by a nitrogen dilution technique and will breathe 8 different inspired volumes. Tidal volumes will be measured using a spirometer.

1 day

1 visit (in-person)

Ultrasonography

Ultrasonographic imaging will be used to calculate pleural strain values at 15 predetermined lung areas using a non-invasive vascular elastography platform.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate adverse effects after the ultrasonography procedure.

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Lung ultrasound

Trial Overview The study is testing the use of lung ultrasound as a tool to measure pulmonary strain in healthy individuals. The goal is to establish normal values for lung strain during mechanical ventilation and understand how it relates to different volumes of air inspired into the lungs.

How Is the Trial Designed?

Group I: Determination of local pleural strain Experimental Treatment 1 Intervention

The average Von Mises coefficient will be calculated for each recorded ultrasound loop using a non-invasive vascular elastography platform.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11988767/

Lung Ultrasound in Mechanical Ventilation: A Purposive ... Conclusions: This review highlights the potential of LUS to improve clinical decision making and patient outcomes in the context of MV. Keywords: lung ...

2. atsjournals.org atsjournals.org/doi/10.1164/rccm.201802-0236CI

Lung Ultrasound for Critically Ill Patients This review describes basic lung ultrasound semiotics and its applications in the critically ill, with specific focus on the mechanically ventilated patient.

3. jtd.amegroups.org jtd.amegroups.org/article/view/103321/html

Lung ultrasound as a diagnostic tool for pulmonary ... Lung ultrasound score (LUSS) is associated with the severity of PCA and intensive care unit (ICU) stay, but not with the duration of mechanical ...

4. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/ryct.2021200564

Lung Ultrasound: The Essentials | Radiology Lung US is a highly sensitive and specific modality that aids in the evaluation of the lungs for many different abnormalities.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024073249

Association of point-of-care lung ultrasound findings with ... Our study demonstrated that DPE >0.95 and NLC ≥3 were associated with PPCs after cardiac surgery based on bedside lung ultrasound findings in the ICU.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12446649/

Lung ultrasound in the management of mechanical ventilation ... This narrative review highlights the growing and multifaceted role of lung ultrasound (LUS) in the management of mechanically ventilated ...