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Regional Assessment of the Risk of Lung Injury in Ventilated Patients

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06486259
Acronym
RLY
Enrollment
10
Registered
2024-07-03
Start date
2023-12-01
Completion date
2024-07-01
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS, Human

Keywords

ARDS, VILI, Mechanical ventilation

Brief summary

Specific characteristics of the lung, such as its functional capacity, heterogeneity, and recruitment potential, can influence the development of ventilator-induced lung injury even under safe ventilation conditions. Objective: To evaluate the risk of ventilator-induced lung injury at the regional level in patients with acute respiratory distress syndrome ventilated with similar tidal volumes and inspiratory pressures.

Detailed description

Mechanical ventilation constitutes a crucial resource serving as a bridge to pulmonary recovery in acute respiratory distress syndrome. However, like any medical intervention, it carries risks of adverse effects, both at the pulmonary and systemic levels. Mechanisms involved in the development of ventilator-induced lung injury include excessive stretching and deformation of lung tissues (stress/strain), cyclic opening and closing of alveoli causing shear stress (atelectrauma injury), and the resulting biological response to tissue damage (biotrauma). To prevent and/or minimize the risk of ventilator-induced lung injury, monitoring of ventilatory mechanics seeks to understand the effects of the ventilatory cycle on the diseased lung. Factors such as tidal volume, plateau pressure, driving pressure, inspiratory flow, respiratory rate, excessive inspiratory effort, and occasionally positive end-expiratory pressure have been directly associated with the mechanism of damage. From an integrative perspective, the concept of mechanical power seeks to encompass most of these factors within a measurable unit thus expressing the energy repeatedly applied to the respiratory system over a unit of time. Mechanical power provides a more comprehensive view of the burden imposed on the lung and can assist in the identification and management of potential risks associated with mechanical ventilation. However, mechanical power is not the only factor involved in the development of VILI, as factors such as the duration of mechanical ventilation and the conditions specific to the diseased lung also play a role.ventilator-induced lung injury results from the relationship between the load imposed by the ventilator and the inability of the lung parenchyma to tolerate it. Factors such as reduced lung functional capacity, heterogeneity of aeration loss, and instability of collapsed alveoli, among others, can modulate the lung's tolerance to mechanical injury and influence the development of ventilator-induced lung injury . Finally, different regional lung conditions may give rise to the coexistence of different injury mechanisms in the same lung. Objective: To evaluate different mechanisms of ventilator-induced lung injury at the regional level in patients with acute respiratory distress syndrome ventilated in the supine position with similar lung load.

Interventions

OTHERControlled mechanical ventilation

Patients were ventilated under similar tidal volume, respiratory rate, and plateau pressure. PEEP was the adjustment variable to reach a similar plateau pressure

Sponsors

Hospital El Cruce
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

ARDS patients \-

Exclusion criteria

Patients with any of the following criteria were excluded: * History of emphysema, asthma, pneumothorax, or active bronchopulmonary fistula. * Severe instability at the time of the study defined by at least one of the following indicators: SaO2 ≤ 90%, shock requiring \> 0.5 γ/kg/min of noradrenaline, complex arrhythmia, myocardial ischemia, intracranial hypertension refractory despite first-line measures. * Esophageal pathology contraindicating esophageal balloon placement (esophageal varices, stenosis, trauma or esophageal surgery, tumor) and/or hematemesis. * Severe coagulopathy (platelet count \<20,000/mm3 or INR \>4. * Inability to undergo computed tomography: morbid obesity (\>170 kg) or abdominal circumference \>200 cm. * Patients with do-not-resuscitate orders and pregnant women. * Participation in another research study in the last 30 days.

Design outcomes

Primary

MeasureTime frameDescription
comparison of regional lung volume1 hourcomparison of regional lung volume in ml

Secondary

MeasureTime frameDescription
comparison of regional volume of hyperinflated lung1 hourcomparison of regional volume of hyperinflated lung in ml
comparison of regional lung deformation1 hourcomparison of regional lung deformation in percentage
comparison of the amount of unstable lung1 hourcomparison of the amount of unstable lung in percentage

Countries

Argentina

Contacts

Primary ContactNestor Pistillo, MD
nestor.pistillo@hospitalelcruce.org01134367989
Backup ContactOsvaldo Fariña, MD
osvaldo.fariña@hospitalelcruce.org01140524299

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026