NCT06486259

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2024

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

June 10, 2024

Last Update Submit

June 26, 2024

Conditions

ARDS, Human

Keywords

ARDSVILIMechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • comparison of regional lung volume

    comparison of regional lung volume in ml

    1 hour

Secondary Outcomes (3)

  • comparison of regional volume of hyperinflated lung

    1 hour

  • comparison of regional lung deformation

    1 hour

  • comparison of the amount of unstable lung

    1 hour

Study Arms (2)

ventral

Ventral half of the lung ..

Other: Controlled mechanical ventilation

Dorsal

Dorsal half of the lung

Other: Controlled mechanical ventilation

Interventions

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

Dorsalventral

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute respiratory distress syndrome requiring mechanical ventilatory assistanc

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital El Cruce

San Juan Bautista, Buenos Aires, 1853, Argentina

RECRUITING

Related Publications (6)

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

    PMID: 5508674BACKGROUND

  • 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.

    PMID: 5537108BACKGROUND

  • 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.

    PMID: 3230208BACKGROUND

  • 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.

    PMID: 9445314BACKGROUND

  • 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.

    PMID: 10673186BACKGROUND

  • 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.

    PMID: 17392642BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Nestor Pistillo, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nestor Pistillo, MD

CONTACT

01134367989nestor.pistillo@hospitalelcruce.org

Osvaldo Fariña, MD

CONTACT

01140524299osvaldo.fariña@hospitalelcruce.org

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 10, 2024

First Posted

July 3, 2024

Study Start

December 1, 2023

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

July 3, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)