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The Variable Ventilation Trial (Part A) (VV (A))

25. august 2026 oppdatert av: Rebecca Baron, Brigham and Women's Hospital

A Bayesian, Operationally Seamless Adaptive Phase 2A/2B, Open-label, Multi-center, Randomized, Two-part Trial to Evaluate the Safety, Efficacy, and Optimal Tidal Volume Distribution of Variable Ventilation (VV) in Participants Undergoing Mechanical Ventilatory Support for Acute Respiratory Distress Syndrome

The goal of this clinical trial is to learn if a breathing machine (ventilator) method called "variable ventilation" can help protect the lungs of adult patients with acute respiratory distress syndrome (ARDS) who need help breathing through a ventilator. In variable ventilation, the size of each breath given by the machine changes slightly from breath to breath, instead of staying the same size in every breath. The study has two parts, A (safety and feasibility) and B (efficacy). This entry will cover the part A (safety study).

The main questions part A aims to answer are:

  1. Is variable ventilation safe to use in adults with ARDS?
  2. Is it feasible to deliver this method of ventilation to patients?

Researchers will compare variable ventilation to the standard breathing machine method used today to see if variable ventilation is safe and feasible.

Participants will be placed on an FDA approved ventilator that can deliver conventional mechanical ventilation and variable ventilation. Participants will:

  • Have a period of stabilization on conventional ventilation, followed by 24 hours of variable ventilation, followed by 24 hours of conventional ventilation.
  • Be checked regularly for breathing, oxygen levels, lung function, and plasma biomarkers.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35294
        • University of Alabama at Birmingham
        • Ta kontakt med:
    • Massachusetts
    • New York
    • Oregon
      • Portland, Oregon, Forente stater, 97239-3098
        • Oregon Health & Science University
    • Utah

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  1. Patients ≥21 years old admitted to the Surgical, Trauma, Burn, Coronary or Medical ICUs with ARDS according to the Berlin criteria [50] and requiring mechanical ventilation will be eligible for inclusion.
  2. Not more than 96 hours of mechanical ventilation before randomization
  3. Anticipated need for at least 48 more hours of controlled mechanical ventilation

  4. Intubated and mechanically ventilated for ARDS according to the Berlin criteria

    • Hypoxemia of acute onset, within the past 7 days
    • Mild or moderate hypoxemia, PaO2/FiO2 ratio 100 - 300 mm Hg
    • Presence of a risk factor for ARDS
    • Respiratory failure not fully explained by cardiac failure or fluid overload
    • Bilateral opacities not explained by effusions, lobar collapse, or nodules

Exclusion Criteria:

Demographic

  1. Age less than 21 years
  2. Pregnant or breastfeeding
  3. Prisoner
  4. Concurrent participation in another investigational drug study
  5. Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if they would receive all supportive care except for attempts at resuscitation from cardiac arrest)
  6. No consent or inability to obtain consent or appropriate legal representative not available
  7. Physician refusal to allow enrollment in the trial
  8. Moribund patient not expected to survive 24 hours
  9. Treating team unwilling to use ARDS network low tidal volume strategy or variable ventilation mode
  10. Use, or planned use of ECMO
  11. Stroke (ischemic or hemorrhagic) or traumatic brain injury (TBI) within the prior 3 months
  12. Burns > 40% total body surface area (TBSA)
  13. Severe airway inhalational injury
  14. Diffuse alveolar hemorrhage

  15. Any of the following hallmarks of Severe COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) grade 3 or 4

    1. FEV1 < 50% predicted
    2. Resting arterial blood gas values PaO2<55, SaO2<88%, or PaCO2>55
    3. Home invasive or non-invasive ventilation other than for sleep apnea
    4. Cor Pulmonale
    5. Candidate for, or has received, lung volume reduction surgery, bronchoscopic intervention to reduce end-expiratory lung volume, or lung transplantation

  16. Any of the following cardiac problems:

    1. Acute myocardial infarction (MI) or acute coronary syndrome within the last 90 days
    2. Coronary artery bypass graft (CABG) surgery within 30 days
    3. Angina pectoris, or use of nitrates, with activities of daily living
    4. Cardiopulmonary disease classified as NYHA class IV

    Physiological Exclusions

  17. Evidence of current barotrauma (e.g., pneumothorax, pneumomediastinum, or subcutaneous emphysema)
  18. Hemodynamic instability defined by inability to maintain a mean arterial pressure > 60 mm Hg.
  19. Other respiratory instability PEEP ≥18 cmH2O, suctioning more than hourly, Pplateau > 35 cm H2O, severe respiratory acidosis pH<7.25.
  20. Increased ICP > 20 cmH2O or mechanism of injury leading to concern for increased ICP
  21. Active bleeding with hemodynamic instability.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Variable Ventilation
Strategy of mechanical ventilation based on varying tidal volume breath to breath to provide therapeutic benefits in patients with ARDS. The variable ventilation (VV) strategy will be implemented on a commercially available ventilator.
Enhet: Variable Ventilation
Strategy of mechanical ventilation based on varying tidal volume breath to breath to provide therapeutic benefits in patients with ARDS.
Placebo komparator: Conventional Ventilation
Standard strategy of mechanical ventilation based on constant size low tidal volume implemented on a commercially available ventilator.
Enhet: Conventional Ventilation
Strategy of mechanical ventilation based on delivery of a constant size low tidal volume.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Tidsramme: Maximum of 24 hours of VV
Barotrauma
Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Tidsramme: Maximum of 24 hours of VV
Worsening Hypoxemia
Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Tidsramme: Maximum of 24 hours of VV
Worsening ventilation
Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Tidsramme: Maximum of 24 hours of VV
New onset arrhythmia requiring cardioversion
Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Tidsramme: Maximum of 24 hours of VV
Hemodynamic instability
Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Tidsramme: Maximum of 24 hours of VV
ST-segment elevation myocardial infarction
Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Tidsramme: Maximum of 24 hours of VV
Self-extubation
Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Tidsramme: Maximum of 24 hours of VV
Stroke
Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Tidsramme: Maximum of 24 hours of VV
Death
Maximum of 24 hours of VV

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Lung mechanics
Tidsramme: Every 12 hours to maximum of 24 hours of VV
Lung compliance, airways resistance, peak and plateau pressures
Every 12 hours to maximum of 24 hours of VV
Gas exchange
Tidsramme: Every 12 hours to maximum of 24 hours of VV
SpO2, PaO2/FiO2 ratio, oxygenation index, dead space, and lung injury score.
Every 12 hours to maximum of 24 hours of VV
Feasibility of VV implementation.
Tidsramme: Every 12 hours during 24 hours of VV
Qualitative feedback from Research and Clinical staff of the device and implementation in the ICU setting.
Every 12 hours during 24 hours of VV

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Brigham and Women's Hospital

Samarbeidspartnere

Boston University
University of Alabama at Birmingham
Oregon Health and Science University
Baystate Medical Center

Etterforskere

  • Hovedetterforsker: Rebecca Baron, MD, Brigham and Women's Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. februar 2027

Primær fullføring (Antatt)

1. februar 2031

Studiet fullført (Antatt)

31. august 2031

Datoer for studieregistrering

Først innsendt

25. august 2026

Først innsendt som oppfylte QC-kriteriene

25. august 2026

Først lagt ut (Faktiske)

27. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026P001935
  • HT94252510768 (Annet stipend/finansieringsnummer: DOD)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

We will only be sharing data in agregate.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

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