NCT06878313

Brief Summary

Mechanical ventilation is essential for managing acute respiratory distress syndrome (ARDS), but it can also cause ventilator-induced lung injury (VILI) due to mechanical forces. VILI results from the interaction between lung structure and mechanical ventilation factors, such as tidal volume, plateau pressure, driving pressure, inspiratory flow, respiratory rate, and PEEP. Intrinsic factors like lung heterogeneity further increase the risk. Elastic power (EP), a key component, is linked to repetitive alveolar stretching and disease progression. Study Objectives: Examine the correlation between elastic power and pulmonary hyperinflation. Compare EP's sensitivity and specificity with other overdistension markers like driving pressure, plateau pressure, upper inflection point, and compliance.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
2mo left

Started Apr 2025

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Apr 2025Jul 2026

First Submitted

Initial submission to the registry

March 11, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

March 11, 2025

Last Update Submit

March 11, 2025

Conditions

Keywords

ARDSVILIMechanical Ventilation

Outcome Measures

Primary Outcomes (1)

  • Comparison between pulmonary hyperinflation and pulmonary elastic power

    1 hour

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients (≥18 years) with moderate-to-severe acute respiratory distress syndrome (ARDS) included in UCI.

You may not qualify if:

  • History of emphysema, asthma, or pneumothorax.
  • Severe instability at the time of the study preventing the PEEP titration maneuver, defined by at least one of the following indicators: SaO₂ ≤ 90%, shock requiring \>0.5 γ/kg/min of norepinephrine, complex arrhythmia, myocardial ischemia, or intracranial hypertension refractory to initial treatment.
  • Patients with do-not-resuscitate orders and pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Xie Y, Shi J, Liu S, Chen X, Wang Y, Li X, Yan Y. Association of elastic power in mechanical ventilation with the severity of acute respiratory distress syndrome: a retrospective study. Eur J Med Res. 2024 Jan 3;29(1):5. doi: 10.1186/s40001-023-01577-7.

    PMID: 38173033BACKGROUND
  • Modesto I Alapont V, Aguar Carrascosa M, Medina Villanueva A. Stress, strain and mechanical power: Is material science the answer to prevent ventilator induced lung injury? Med Intensiva (Engl Ed). 2019 Apr;43(3):165-175. doi: 10.1016/j.medin.2018.06.008. Epub 2018 Nov 5. No abstract available. English, Spanish.

    PMID: 30409677BACKGROUND
  • Marini JJ, Thornton LT, Rocco PRM, Crooke PS. From pressure to tension: a model of damaging inflation stress. Crit Care. 2023 Nov 15;27(1):441. doi: 10.1186/s13054-023-04675-4.

    PMID: 37968744BACKGROUND
  • Gattinoni L, Marini JJ, Collino F, Maiolo G, Rapetti F, Tonetti T, Vasques F, Quintel M. The future of mechanical ventilation: lessons from the present and the past. Crit Care. 2017 Jul 12;21(1):183. doi: 10.1186/s13054-017-1750-x.

    PMID: 28701178BACKGROUND

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of intensive care

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 14, 2025

Study Start

April 1, 2025

Primary Completion

April 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 14, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share