ARDS (Acute Respiratory Distress Syndrome)
Conditions
Brief 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. 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.
Interventions
DEVICEVariable Ventilation
Strategy of mechanical ventilation based on varying tidal volume breath to breath to provide therapeutic benefits in patients with ARDS.
DEVICEConventional Ventilation
Strategy of mechanical ventilation based on delivery of a constant size low tidal volume.
Sponsors
Brigham and Women's Hospital
Baystate Medical Center
Boston University
Oregon Health and Science University
University of Alabama at Birmingham
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking will be used in this study.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessed by the incidence of pre-specified AEs over the first 24 hours | Maximum of 24 hours of VV | Barotrauma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung mechanics | Every 12 hours to maximum of 24 hours of VV | Lung compliance, airways resistance, peak and plateau pressures |
| Gas exchange | Every 12 hours to maximum of 24 hours of VV | SpO2, PaO2/FiO2 ratio, oxygenation index, dead space, and lung injury score. |
| Feasibility of VV implementation. | Every 12 hours during 24 hours of VV | Qualitative feedback from Research and Clinical staff of the device and implementation in the ICU setting. |
Countries
United States
Contacts
CONTACTRebecca Baron, MD
PRINCIPAL_INVESTIGATORRebecca Baron, MD
Brigham and Women's Hospital
Outcome results
None listed