Regional Assessment of the Risk of Lung Injury in Ventilated Patients (RLY)

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

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.

Study Overview

• Status: Recruiting
• Conditions: ARDS, Human
• Intervention / Treatment: Other: Controlled mechanical ventilation

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.

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: Nestor Pistillo, MD; Phone Number: 01134367989; Email: nestor.pistillo@hospitalelcruce.org
• Study Contact Backup: Name: Osvaldo Fariña, MD; Phone Number: 01140524299; Email: osvaldo.fariña@hospitalelcruce.org

Study Locations

• Argentina
  • Buenos Aires
    • Florencio Varela, Buenos Aires, Argentina, 1853
      • Recruiting
      • Hospital El Cruce
      • Contact: Nestor Pistillo, MD; Phone Number: 01134367989; Email: nestor.pistillo@hospitalelcruce.org
      • Contact: Osvaldo Fariña; Phone Number: 01140524299; Email: osvaldo.fariña@hospitalelcruce.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute respiratory distress syndrome requiring mechanical ventilatory assistanc

Description

Inclusion Criteria: ARDS patients

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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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ventral; Ventral half of the lung ..	Other: Controlled 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
Dorsal; Dorsal half of the lung	Other: Controlled 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison of regional lung volume	comparison of regional lung volume in ml	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison of regional volume of hyperinflated lung	comparison of regional volume of hyperinflated lung in ml	1 hour
comparison of regional lung deformation	comparison of regional lung deformation in percentage	1 hour
comparison of the amount of unstable lung	comparison of the amount of unstable lung in percentage	1 hour

Collaborators and Investigators

• Sponsor: Hospital El Cruce
• Investigators: Principal Investigator: Nestor Pistillo, MD, Hospital de Alta Complejidad en Red El Cruce Néstor C. Kirchner

Publications and helpful links

General Publications

• Dreyfuss D, Saumon G. Ventilator-induced lung injury: lessons from experimental studies. Am J Respir Crit Care Med. 1998 Jan;157(1):294-323. doi: 10.1164/ajrccm.157.1.9604014. No abstract available.
• Vinokurenko VM. [Dependence of dark adaptation on climatic factors]. Voen Med Zh. 1970 Dec;12:62-3. No abstract available. Russian.
• Vallejo-Nagera JA. [New dimensions in the physician-patient relations]. An R Acad Nac Med (Madr). 1970;87(3):247-54. No abstract available. Spanish.
• Mascheroni D, Kolobow T, Fumagalli R, Moretti MP, Chen V, Buckhold D. Acute respiratory failure following pharmacologically induced hyperventilation: an experimental animal study. Intensive Care Med. 1988;15(1):8-14. doi: 10.1007/BF00255628.
• Hotchkiss JR Jr, Blanch L, Murias G, Adams AB, Olson DA, Wangensteen OD, Leo PH, Marini JJ. Effects of decreased respiratory frequency on ventilator-induced lung injury. Am J Respir Crit Care Med. 2000 Feb;161(2 Pt 1):463-8. doi: 10.1164/ajrccm.161.2.9811008.
• Fujita Y, Fujino Y, Uchiyama A, Mashimo T, Nishimura M. High peak inspiratory flow can aggravate ventilator-induced lung injury in rabbits. Med Sci Monit. 2007 Apr;13(4):BR95-100.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: ARDS; Mechanical ventilation; VILI
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Respiratory Distress Syndrome; Lung Injury
• Other Study ID Numbers: EL CRUCE HOSPITAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No