Actively Recruiting

Age: 18Years - 75Years
All Genders
ID06486259

Regional Assessment of the Risk of Lung Injury in Ventilated Patients With Similar Lung Load

Led by Hospital El Cruce · Updated on 2024-07-03

10

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the risk of lung injury caused by mechanical ventilation in patients with acute respiratory distress syndrome (ARDS). The study focuses on how different lung characteristics like functional capacity, uneven lung aeration, and alveolar stability affect the chance of ventilator-induced lung injury, even when using similar safe ventilation settings. This observational study aims to better understand injury mechanisms occurring in different lung regions during ventilation in the supine position. The study observes patients receiving controlled mechanical ventilation where tidal volume, respiratory rate, and plateau pressure are kept similar. Positive end-expiratory pressure (PEEP) is adjusted to maintain a similar plateau pressure. Researchers compare lung injury mechanisms between the ventral (front) and dorsal (back) halves of the lung, evaluating regional lung volume, lung deformation, hyperinflated areas, and unstable lung tissue. Participants will be monitored during one-hour assessment periods where lung volumes and deformations are measured regionally. Various clinical parameters and imaging may be used to assess lung mechanics and injury risk. The research team will analyze these measurements to understand differences in lung response to ventilation. The study excludes patients with certain lung diseases or conditions that could interfere with monitoring or pose safety risks. The overall participation duration and follow-up depend on patient condition and study protocols.

CONDITIONS

Brief Title

Regional Assessment of the Risk of Lung Injury in Ventilated Patients

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 75 years
  • Diagnosis of acute respiratory distress syndrome (ARDS)
Not Eligible

You will not qualify if you...

  • History of emphysema, asthma, pneumothorax, or active bronchopulmonary fistula
  • Severe instability at the time of study such as low oxygen saturation, shock requiring high-dose noradrenaline, complex arrhythmia, myocardial ischemia, or refractory intracranial hypertension
  • Esophageal conditions preventing esophageal balloon placement or causing bleeding
  • Severe blood clotting disorders (platelets below 20,000/mm3 or INR above 4)
  • Inability to undergo computed tomography due to morbid obesity or large abdominal circumference
  • Do-not-resuscitate orders
  • Pregnancy
  • Participation in another research study within the last 30 days

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Approximately 1 hour

Participants undergoing mechanical ventilation are observed to evaluate regional lung injury mechanisms under controlled ventilation settings.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Hospital El Cruce

San Juan Bautista, Buenos Aires, Argentina, 1853

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Research Team

N

Nestor Pistillo, MD

O

Osvaldo Fariña, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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