Individualized Positive End-expiratory Pressure Guided by End-expiratory Lung Volume in the Acute Respiratory Distress Syndrome

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Jul 4, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new way to set a specific breathing support called Positive End-Expiratory Pressure (PEEP) for patients with acute respiratory distress syndrome (ARDS). Researchers believe that by tailoring PEEP settings based on individual patients' lung needs, they can improve their overall health outcomes. The trial will measure a specific lung volume to determine the best PEEP level for each patient, which may help their lungs work better during treatment.

To be eligible for the trial, participants must be adults aged 18 to 85 who have been diagnosed with ARDS within the last week and are on mechanical ventilation. Key inclusion criteria include having difficulty breathing with a specific level of oxygen in the blood and showing certain lung patterns on imaging tests. Throughout the trial, participants will be closely monitored to see how well this personalized approach to PEEP works compared to standard methods. It's important to note that certain health conditions, such as pregnancy or severe heart issues, may exclude someone from participating in the study.

Gender

ALL

Eligibility criteria

• Eligibility inclusion criteria, according to the ARDS Berlin definition, will be assessed within the first 24 hours from the initiation of invasive mechanical ventilation:
• • 1. Acute respiratory failure within 1 week of a known clinical insult or new or worsening respiratory symptoms;
• • 2. Bilateral infiltrates at the chest x-ray or CT scan, not fully explained by effusions, lobar/lung collapse, or nodules;
• • 3. Respiratory failure not fully explained by cardiac failure or fluid overload; objective assessment required to exclude hydrostatic edema if no risk factor present.
• • 4. PaO2/FiO2 ratio≤150 mmHg after 30 mins - 1 hour of mechanical ventilation with PEEP=5 cmH2O.
• • 5. Written informed consent.
• Exclusion Criteria:
• • 1. Pregnancy;
• • 2. Pneumothorax;
• • 3. Acute brain injury;
• • 4. Clinical signs of history of decompensated heart failure (New York Heart Association class 3-4 before the acute phase of the disease or documented ejection fraction\<35% or pulmonary capillary wedge pressure\>18 mmHg) or acute coronary syndrome;
• • 5. Intubation as a result of an acute exacerbation of chronic pulmonary disease: chronic obstructive pulmonary disease, asthma, cystic fibrosis, etc;
• • 6. Clinically evident intrinsic PEEP (≥2 cmH2O) during screening visit (End-expiratory pause to achieve Flow=0);
• • 7. BMI\>35;
• • 8. BMI\<15 or body weight\<35 Kg;
• • 9. Any chronic disease requiring long-term oxygen therapy or mechanical ventilation at home;
• • 10. Neuromuscular disease of any kind;
• • 11. Severe chronic liver disease (Child-Pugh C or worse);
• • 12. Bone marrow transplantation or chemotherapy-induced neutropenia;
• • 13. History of liver or lung transplant;
• • 14. Decision to withhold life-sustaining treatment;
• • 15. Need for therapy with inhaled nitric oxide due to documented pulmonary arterial hypertension;
• • 16. Life-threatening hypoxemia deemed to require extracorporeal membrane oxygenation (ECMO);
• • 17. Presence of documented barotrauma;
• • 18. High risk of mortality within 3 months from other than ARDS (severe neurological damage, age \>85 years and cancer patients in terminal stages of the disease).
• • 19. Persistent hemodynamic instability, intractable shock (norepinephrine\>1 mcg/kg/h and/or blood lactate\>5 mmol/L and/or considered too hemodynamically unstable for enrolment in the study by the patient's managing physician).
• • 20. More than 24 hours from endotracheal intubation to the time of the screening visit.