ARDS (Acute Respiratory Distress Syndrome)VV (A)NCT07791225
The Variable Ventilation Trial (Part A)
A study testing Variable Ventilation and Conventional Ventilation in people with ARDS (Acute Respiratory Distress Syndrome), run by Brigham and Women's Hospital at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome)
- What is being tested?
- Variable Ventilation and Conventional Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Feb 2027to 31 Aug 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Not more than 96 hours of mechanical ventilation before randomization
- Anticipated need for at least 48 more hours of controlled mechanical ventilation
- 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
Show all 9Show fewer
- 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
Who cannot join
- Demographic
- Age less than 21 years
- Pregnant or breastfeeding
- Prisoner
- Concurrent participation in another investigational drug study
- 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)
Show all 32Show fewer
- No consent or inability to obtain consent or appropriate legal representative not available
- Physician refusal to allow enrollment in the trial
- Moribund patient not expected to survive 24 hours
- Treating team unwilling to use ARDS network low tidal volume strategy or variable ventilation mode
- Use, or planned use of ECMO
- Stroke (ischemic or hemorrhagic) or traumatic brain injury (TBI) within the prior 3 months
- Burns > 40% total body surface area (TBSA)
- Severe airway inhalational injury
- Diffuse alveolar hemorrhage
- Any of the following hallmarks of Severe COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) grade 3 or 4
- FEV1 < 50% predicted
- Resting arterial blood gas values PaO2<55, SaO2<88%, or PaCO2>55
- Home invasive or non-invasive ventilation other than for sleep apnea
- Cor Pulmonale
- Candidate for, or has received, lung volume reduction surgery, bronchoscopic intervention to reduce end-expiratory lung volume, or lung transplantation
- Any of the following cardiac problems:
- Acute myocardial infarction (MI) or acute coronary syndrome within the last 90 days
- Coronary artery bypass graft (CABG) surgery within 30 days
- Angina pectoris, or use of nitrates, with activities of daily living
- Cardiopulmonary disease classified as NYHA class IV
- Physiological Exclusions
- Evidence of current barotrauma (e.g., pneumothorax, pneumomediastinum, or subcutaneous emphysema)
- Hemodynamic instability defined by inability to maintain a mean arterial pressure > 60 mm Hg.
- Other respiratory instability PEEP ≥18 cmH2O, suctioning more than hourly, Pplateau > 35 cm H2O, severe respiratory acidosis pH<7.25.
- Increased ICP > 20 cmH2O or mechanism of injury leading to concern for increased ICP
- Active bleeding with hemodynamic instability.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Peter Morris, MD, pmorris@uabmc.edu
Intermountain Health Intermountain Medical Center
Murray, Utah, 84107
Jessica Reimer, Jessica.Reimer@imail.org
Emma Murphy, Emma.Murphy@imail.org
Oregon Health & Science University
Portland, Oregon, 97239-3098
Baystate Health
Springfield, Massachusetts, 01199
Mark Tidswell, MD, mark.tidswell@baystatehealth.org
Montefiore Einstein
The Bronx, New York, 10461
Luke Andrea, 314-705-0925, landrea@montefiore.org
Daniel Ceusters, dceuster@montefiore.org
About this study
Official title: 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:
Read more
- Is variable ventilation safe to use in adults with ARDS?
- 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.
- Being tested
- Variable Ventilation, Conventional Ventilation
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Variable VentilationDevice
Strategy of mechanical ventilation based on varying tidal volume breath to breath to provide therapeutic benefits in patients with ARDS.
Conventional VentilationDevice
Strategy of mechanical ventilation based on delivery of a constant size low tidal volume.
| Study group | Role | What they receive |
|---|---|---|
| Variable Ventilation | Experimental | 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. Receives: Device: Variable Ventilation |
| Conventional Ventilation | Placebo comparator | Standard strategy of mechanical ventilation based on constant size low tidal volume implemented on a commercially available ventilator. Receives: Device: Conventional Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Barotrauma
Measured: Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Worsening Hypoxemia
Measured: Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Worsening ventilation
Measured: Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
New onset arrhythmia requiring cardioversion
Measured: Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Hemodynamic instability
Measured: Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
ST-segment elevation myocardial infarction
Measured: Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Self-extubation
Measured: Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Stroke
Measured: Maximum of 24 hours of VV
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Death
Measured: Maximum of 24 hours of VV
Secondary outcomes (3)
Lung mechanics
Lung compliance, airways resistance, peak and plateau pressures
Measured: Every 12 hours to maximum of 24 hours of VV
Gas exchange
SpO2, PaO2/FiO2 ratio, oxygenation index, dead space, and lung injury score.
Measured: Every 12 hours to maximum of 24 hours of VV
Feasibility of VV implementation.
Qualitative feedback from Research and Clinical staff of the device and implementation in the ICU setting.
Measured: Every 12 hours during 24 hours of VV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Feb 2027 (estimated)
- Primary completion1 Feb 2031 (estimated)
- Study completion31 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for ARDS (Acute Respiratory Distress Syndrome)Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Baystate Medical Center, Boston University, Oregon Health and Science University, University of Alabama at Birmingham
- Responsible party
- Principal investigator, Rebecca Baron, Brigham and Women's Hospital
- Investigators
- Rebecca Baron, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791225
- Sponsor's protocol ID
- 2026P001935
- Other IDs
- HT94252510768
- Acronym
- VV (A)
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We will only be sharing data in agregate.
Publications
Pillow JJ, Musk GC, McLean CM, Polglase GR, Dalton RG, Jobe AH, Suki B. Variable ventilation improves ventilation and lung compliance in preterm lambs. Intensive Care Med. 2011 Aug;37(8):1352-9. doi: 10.1007/s00134-011-2237-x. Epub 2011 May 13.
PubMed 21567115Suki B, Parameswaran H, Imsirovic J, Bartolak-Suki E. Regulatory Roles of Fluctuation-Driven Mechanotransduction in Cell Function. Physiology (Bethesda). 2016 Sep;31(5):346-58. doi: 10.1152/physiol.00051.2015.
PubMed 27511461Berry CA, Suki B, Polglase GR, Pillow JJ. Variable ventilation enhances ventilation without exacerbating injury in preterm lambs with respiratory distress syndrome. Pediatr Res. 2012 Oct;72(4):384-92. doi: 10.1038/pr.2012.97. Epub 2012 Jul 17.
PubMed 22805999Bartolak-Suki E, Imsirovic J, Parameswaran H, Wellman TJ, Martinez N, Allen PG, Frey U, Suki B. Fluctuation-driven mechanotransduction regulates mitochondrial-network structure and function. Nat Mater. 2015 Oct;14(10):1049-57. doi: 10.1038/nmat4358. Epub 2015 Jul 27.
PubMed 26213900Arold SP, Bartolak-Suki E, Suki B. Variable stretch pattern enhances surfactant secretion in alveolar type II cells in culture. Am J Physiol Lung Cell Mol Physiol. 2009 Apr;296(4):L574-81. doi: 10.1152/ajplung.90454.2008. Epub 2009 Jan 9.
PubMed 19136581Pillow JJ, Bartolak-Suki E, Noble PB, Berry CA, Suki B. Surfactant Protein Production during Maturation Is Enhanced by Natural Variability in Breathing. Am J Respir Cell Mol Biol. 2023 Jul;69(1):115-118. doi: 10.1165/rcmb.2022-0411LE. No abstract available.
PubMed 37387612Bellardine CL, Hoffman AM, Tsai L, Ingenito EP, Arold SP, Lutchen KR, Suki B. Comparison of variable and conventional ventilation in a sheep saline lavage lung injury model. Crit Care Med. 2006 Feb;34(2):439-45. doi: 10.1097/01.ccm.0000196208.01682.87.
PubMed 16424726Arold SP, Suki B, Alencar AM, Lutchen KR, Ingenito EP. Variable ventilation induces endogenous surfactant release in normal guinea pigs. Am J Physiol Lung Cell Mol Physiol. 2003 Aug;285(2):L370-5. doi: 10.1152/ajplung.00036.2003.
PubMed 12851212Thammanomai A, Hueser LE, Majumdar A, Bartolak-Suki E, Suki B. Design of a new variable-ventilation method optimized for lung recruitment in mice. J Appl Physiol (1985). 2008 May;104(5):1329-40. doi: 10.1152/japplphysiol.01002.2007. Epub 2008 Mar 13.
PubMed 18339891Bartolak-Suki E, Noble PB, Bou Jawde S, Pillow JJ, Suki B. Optimization of Variable Ventilation for Physiology, Immune Response and Surfactant Enhancement in Preterm Lambs. Front Physiol. 2017 Jun 23;8:425. doi: 10.3389/fphys.2017.00425. eCollection 2017.
PubMed 28690548Thammanomai A, Hamakawa H, Bartolak-Suki E, Suki B. Combined effects of ventilation mode and positive end-expiratory pressure on mechanics, gas exchange and the epithelium in mice with acute lung injury. PLoS One. 2013;8(1):e53934. doi: 10.1371/journal.pone.0053934. Epub 2013 Jan 9.
PubMed 23326543Suki B, Alencar AM, Sujeer MK, Lutchen KR, Collins JJ, Andrade JS Jr, Ingenito EP, Zapperi S, Stanley HE. Life-support system benefits from noise. Nature. 1998 May 14;393(6681):127-8. doi: 10.1038/30130. No abstract available.
PubMed 9603516Arold SP, Mora R, Lutchen KR, Ingenito EP, Suki B. Variable tidal volume ventilation improves lung mechanics and gas exchange in a rodent model of acute lung injury. Am J Respir Crit Care Med. 2002 Feb 1;165(3):366-71. doi: 10.1164/ajrccm.165.3.2010155.
PubMed 11818322Dellaca RL, Aliverti A, Lo Mauro A, Lutchen KR, Pedotti A, Suki B. Correlated variability in the breathing pattern and end-expiratory lung volumes in conscious humans. PLoS One. 2015 Mar 24;10(3):e0116317. doi: 10.1371/journal.pone.0116317. eCollection 2015.
PubMed 25803710
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07791225
- Acronym / sponsor ID
- VV (A) / 2026P001935
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Baystate Medical Center, Boston University, Oregon Health and Science University, University of Alabama at Birmingham
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Feb 2031 (estimated)
- Study completion
- 31 Aug 2031 (estimated)
- First posted
- 27 Aug 2026 (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.
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:
- Is variable ventilation safe to use in adults with ARDS?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Variable Ventilation | Experimental | Device: Variable VentilationStrategy 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. |
| Conventional Ventilation | Placebo comparator | Device: Conventional VentilationStandard strategy of mechanical ventilation based on constant size low tidal volume implemented on a commercially available ventilator. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Not more than 96 hours of mechanical ventilation before randomization
- Anticipated need for at least 48 more hours of controlled mechanical ventilation
- Intubated and mechanically ventilated for ARDS according to the Berlin criteria
Key exclusion criteria (32 listed)
- Demographic
- Age less than 21 years
- Pregnant or breastfeeding
- Prisoner
- Concurrent participation in another investigational drug study
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 |
|---|---|---|
| Variable VentilationStrategy of mechanical ventilation based on varying tidal volume breath to breath to provide therapeutic benefits in patients with ARDS. | Device | Variable Ventilation |
| Conventional VentilationStrategy of mechanical ventilation based on delivery of a constant size low tidal volume. | Device | Conventional Ventilation |
Primary outcome
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Time frame: Maximum of 24 hours of VV
Barotrauma
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Time frame: Maximum of 24 hours of VV
Worsening Hypoxemia
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Time frame: Maximum of 24 hours of VV
Worsening ventilation
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Time frame: Maximum of 24 hours of VV
New onset arrhythmia requiring cardioversion
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Time frame: Maximum of 24 hours of VV
Hemodynamic instability
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Time frame: Maximum of 24 hours of VV
ST-segment elevation myocardial infarction
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Time frame: Maximum of 24 hours of VV
Self-extubation
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Time frame: Maximum of 24 hours of VV
Stroke
Safety assessed by the incidence of pre-specified AEs over the first 24 hours
Time frame: Maximum of 24 hours of VV
Death
3 secondary outcomes
Lung mechanics
Time frame: Every 12 hours to maximum of 24 hours of VV
Gas exchange
Time frame: Every 12 hours to maximum of 24 hours of VV
Feasibility of VV implementation.
Time frame: Every 12 hours during 24 hours of VV
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Background: PubMed 21567115Pillow JJ, Musk GC, McLean CM, Polglase GR, Dalton RG, Jobe AH, Suki B. Variable ventilation improves ventilation and lung compliance in preterm lambs. Intensive Care Med. 2011 Aug;37(8):1352-9. doi: 10.1007/s00134-011-2237-x. Epub 2011 May 13.
- Background: PubMed 27511461Suki B, Parameswaran H, Imsirovic J, Bartolak-Suki E. Regulatory Roles of Fluctuation-Driven Mechanotransduction in Cell Function. Physiology (Bethesda). 2016 Sep;31(5):346-58. doi: 10.1152/physiol.00051.2015.
- Background: PubMed 22805999Berry CA, Suki B, Polglase GR, Pillow JJ. Variable ventilation enhances ventilation without exacerbating injury in preterm lambs with respiratory distress syndrome. Pediatr Res. 2012 Oct;72(4):384-92. doi: 10.1038/pr.2012.97. Epub 2012 Jul 17.
- Background: PubMed 26213900Bartolak-Suki E, Imsirovic J, Parameswaran H, Wellman TJ, Martinez N, Allen PG, Frey U, Suki B. Fluctuation-driven mechanotransduction regulates mitochondrial-network structure and function. Nat Mater. 2015 Oct;14(10):1049-57. doi: 10.1038/nmat4358. Epub 2015 Jul 27.
- Background: PubMed 19136581Arold SP, Bartolak-Suki E, Suki B. Variable stretch pattern enhances surfactant secretion in alveolar type II cells in culture. Am J Physiol Lung Cell Mol Physiol. 2009 Apr;296(4):L574-81. doi: 10.1152/ajplung.90454.2008. Epub 2009 Jan 9.
- Background: PubMed 37387612Pillow JJ, Bartolak-Suki E, Noble PB, Berry CA, Suki B. Surfactant Protein Production during Maturation Is Enhanced by Natural Variability in Breathing. Am J Respir Cell Mol Biol. 2023 Jul;69(1):115-118. doi: 10.1165/rcmb.2022-0411LE. No abstract available.
- Background: PubMed 16424726Bellardine CL, Hoffman AM, Tsai L, Ingenito EP, Arold SP, Lutchen KR, Suki B. Comparison of variable and conventional ventilation in a sheep saline lavage lung injury model. Crit Care Med. 2006 Feb;34(2):439-45. doi: 10.1097/01.ccm.0000196208.01682.87.
- Background: PubMed 12851212Arold SP, Suki B, Alencar AM, Lutchen KR, Ingenito EP. Variable ventilation induces endogenous surfactant release in normal guinea pigs. Am J Physiol Lung Cell Mol Physiol. 2003 Aug;285(2):L370-5. doi: 10.1152/ajplung.00036.2003.
- Background: PubMed 18339891Thammanomai A, Hueser LE, Majumdar A, Bartolak-Suki E, Suki B. Design of a new variable-ventilation method optimized for lung recruitment in mice. J Appl Physiol (1985). 2008 May;104(5):1329-40. doi: 10.1152/japplphysiol.01002.2007. Epub 2008 Mar 13.
- Background: PubMed 28690548Bartolak-Suki E, Noble PB, Bou Jawde S, Pillow JJ, Suki B. Optimization of Variable Ventilation for Physiology, Immune Response and Surfactant Enhancement in Preterm Lambs. Front Physiol. 2017 Jun 23;8:425. doi: 10.3389/fphys.2017.00425. eCollection 2017.
- Background: PubMed 23326543Thammanomai A, Hamakawa H, Bartolak-Suki E, Suki B. Combined effects of ventilation mode and positive end-expiratory pressure on mechanics, gas exchange and the epithelium in mice with acute lung injury. PLoS One. 2013;8(1):e53934. doi: 10.1371/journal.pone.0053934. Epub 2013 Jan 9.
- Background: PubMed 9603516Suki B, Alencar AM, Sujeer MK, Lutchen KR, Collins JJ, Andrade JS Jr, Ingenito EP, Zapperi S, Stanley HE. Life-support system benefits from noise. Nature. 1998 May 14;393(6681):127-8. doi: 10.1038/30130. No abstract available.
- Individual participant dataSharing planned: No. We will only be sharing data in agregate.
Related trials for ARDS (Acute Respiratory Distress Syndrome)
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
RecruitingObservational study
Pulmonary Immune Cell-microbiome Interactions in ARDS
ARDS, Human
RecruitingPhase 2
Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
Acute Respiratory Distress Syndrome, Infections
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Not yet recruitingObservational study
Right Heart Injury Monitoring on ECMO
Acute Respiratory Distress Syndrome (ARDS), Acute Respiratory Failure (ARF)
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.
Rebecca Baron, MD principal investigator
Brigham and Women's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Variable Ventilation and Conventional Ventilation in people with ARDS (Acute Respiratory Distress Syndrome), run by Brigham and Women's Hospital at 5 sites in United States.
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 32 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: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Baron, MD (617-525-6642, rbaron@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessed by the incidence of pre-specified AEs over the first 24 hours (time frame: Maximum of 24 hours of VV). The study lists 9 primary outcomes in all. 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 NCT07791225, which also lists 14 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 27 Aug 2026.