Regional Assessment of the Risk of Lung Injury in Ventilated Patients

NCT ID: NCT06486259

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-07-01

Brief Summary

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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

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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.

Conditions

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ARDS, Human

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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ventral

Ventral half of the lung

..

Controlled mechanical ventilation

Intervention Type OTHER

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

Controlled mechanical ventilation

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital El Cruce

OTHER

Sponsor Role lead

Responsible Party

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Nestor Pistillo

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nestor Pistillo, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Alta Complejidad en Red El Cruce Néstor C. Kirchner

Locations

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Hospital El Cruce

San Juan Bautista, Buenos Aires, Argentina

Site Status RECRUITING

Countries

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Argentina

Central Contacts

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Nestor Pistillo, MD

Role: CONTACT

01134367989

Osvaldo Fariña, MD

Role: CONTACT

Facility Contacts

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Nestor Pistillo, MD

Role: primary

01134367989

Osvaldo Fariña

Role: backup

References

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Vinokurenko VM. [Dependence of dark adaptation on climatic factors]. Voen Med Zh. 1970 Dec;12:62-3. No abstract available. Russian.

Reference Type BACKGROUND
PMID: 5508674 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 5537108 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3230208 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9445314 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10673186 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17392642 (View on PubMed)

Other Identifiers

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EL CRUCE HOSPITAL

Identifier Type: -

Identifier Source: org_study_id

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