ARDS, HumanRLYNCT06486259
Regional Assessment of the Risk of Lung Injury in Ventilated Patients
An observational study of ARDS, Human, run by Hospital El Cruce at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ARDS, Human
- How many people
- 10 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Dec 2023to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute respiratory distress syndrome requiring mechanical ventilatory assistanc
Who may be able to join
- -
- 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.
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Hospital El Cruce
San Juan Bautista, Buenos Aires, 1853
Nestor Pistillo, MD, 01134367989, nestor.pistillo@hospitalelcruce.org
Osvaldo Fariña, 01140524299, osvaldo.fariña@hospitalelcruce.org
About this study
Official title: 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.
Read the 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.
- Conditions
- ARDS, Human
- Being tested
- Controlled mechanical ventilation
- Keywords
- ARDS, VILI, Mechanical ventilation
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled mechanical ventilationOther
Patients were ventilated under similar tidal volume, respiratory rate, and plateau pressure. PEEP was the adjustment variable to reach a similar plateau pressure
| Study group | Role | What they receive |
|---|---|---|
| ventral | Ventral half of the lung
.. Receives: Other: Controlled mechanical ventilation | |
| Dorsal | Dorsal half of the lung Receives: Other: Controlled mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of regional lung volume
comparison of regional lung volume in ml
Measured: 1 hour
Secondary outcomes (3)
comparison of regional volume of hyperinflated lung
comparison of regional volume of hyperinflated lung in ml
Measured: 1 hour
comparison of regional lung deformation
comparison of regional lung deformation in percentage
Measured: 1 hour
comparison of the amount of unstable lung
comparison of the amount of unstable lung in percentage
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Dec 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ARDS, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital El Cruce
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nestor Pistillo, Hospital El Cruce
- Investigators
- Nestor Pistillo, MD, Principal investigator, Hospital de Alta Complejidad en Red El Cruce Néstor C. Kirchner
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486259
- Sponsor's protocol ID
- EL CRUCE HOSPITAL
- Acronym
- RLY
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vinokurenko VM. [Dependence of dark adaptation on climatic factors]. Voen Med Zh. 1970 Dec;12:62-3. No abstract available. Russian.
PubMed 5508674Vallejo-Nagera JA. [New dimensions in the physician-patient relations]. An R Acad Nac Med (Madr). 1970;87(3):247-54. No abstract available. Spanish.
PubMed 5537108Mascheroni 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.
PubMed 3230208Dreyfuss 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.
PubMed 9445314Hotchkiss 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.
PubMed 10673186Fujita 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.
PubMed 17392642
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Assessment of the Risk of Lung Injury in Ventilated Patients With Similar Lung Load
- ClinicalTrials.gov ID
- NCT06486259
- Acronym / sponsor ID
- RLY / EL CRUCE HOSPITAL
- Conditions
- ARDS, Human
- Keywords
- ARDS, VILI, Mechanical ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hospital El CruceUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ventral | – | Other: Controlled mechanical ventilationVentral half of the lung .. |
| Dorsal | – | Other: Controlled mechanical ventilationDorsal half of the lung |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute respiratory distress syndrome requiring mechanical ventilatory assistanc
Key inclusion criteria (9 listed)
- -
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled mechanical ventilationPatients were ventilated under similar tidal volume, respiratory rate, and plateau pressure. PEEP was the adjustment variable to reach a similar plateau pressure | Other | Dorsal, ventral |
Primary outcome
comparison of regional lung volume
Time frame: 1 hour
comparison of regional lung volume in ml
3 secondary outcomes
comparison of regional volume of hyperinflated lung
Time frame: 1 hour
comparison of regional lung deformation
Time frame: 1 hour
comparison of the amount of unstable lung
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 5508674Vinokurenko VM. [Dependence of dark adaptation on climatic factors]. Voen Med Zh. 1970 Dec;12:62-3. No abstract available. Russian.
- Background: PubMed 5537108Vallejo-Nagera JA. [New dimensions in the physician-patient relations]. An R Acad Nac Med (Madr). 1970;87(3):247-54. No abstract available. Spanish.
- Background: PubMed 3230208Mascheroni 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.
- Background: PubMed 9445314Dreyfuss 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.
- Background: PubMed 10673186Hotchkiss 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.
- Background: PubMed 17392642Fujita 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nestor Pistillo, MD principal investigator
Hospital de Alta Complejidad en Red El Cruce Néstor C. Kirchner
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS, Human, run by Hospital El Cruce at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nestor Pistillo, MD (01134367989, nestor.pistillo@hospitalelcruce.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of regional lung volume (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06486259, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.