Evaluating ventilatory parameters to predict outcomes in ARDS patients
Occlusion Pressure at 100 Msec, TCe ( Expiratory Time Constant ), Stress Energy Density, Mechanical Power, Ventilatory Ratio and C20/Cdyn in Predicting Outcomes in Patients With Moderately Severe ARDS, Who Are on Mechanical Ventilation
This study is testing whether certain breathing measurements can help predict how well patients with moderate Acute Respiratory Distress Syndrome (ARDS) will do while on a ventilator.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | CentraCare Academic / other |
| Locations | 1 site (Saint Cloud, Minnesota) |
| Trial ID | NCT06400095 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess whether specific ventilatory parameters, such as occlusion pressure and expiratory time constant, can predict outcomes in patients with moderately severe Acute Respiratory Distress Syndrome (ARDS) who are on mechanical ventilation. The study will analyze the relationship between mechanical power, driving pressure, and patient outcomes, focusing on the risks of ventilation-induced lung injury. By monitoring these parameters, the researchers hope to improve understanding of how mechanical ventilation affects ARDS patients and potentially guide treatment strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with severe ARDS requiring mechanical ventilation and exhibiting a PF ratio of less than 150.
Not a fit: Patients with conditions such as COPD, pulmonary fibrosis, or those requiring ECMO may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction of outcomes for ARDS patients on mechanical ventilation, potentially enhancing patient management and care.
How similar studies have performed: Other studies have indicated that mechanical power and driving pressure can predict mortality in ARDS patients, suggesting this approach has a foundation in previous research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with Acute respiratory failure needing mechanical ventilation * Diagnosis of Severe ARDS with severity: PF ratio \< 150, with PEEP/CPAP \> 5 Exclusion Criteria: * r2 \< 0.95, monitored on the ventilator * Expiratory flow that is not first-order or non-exponential decay * Patients with Nor-epinephrine requirements \> 0.1 mcg/kg/min within 2 hours of intubation * Patients requiring ECMO ( Extracorporeal membrane oxygenation) * Patients with COPD or pulmonary fibrosis with a premorbid FEV1 \< 1.5 L * Severe atherosclerotic vascular disease * Patients with a chest tube, intra-abdominal hypertension or with its risk factors * Patients with structural heart disease including pulmonary hypertension (RVSP \> 45) and heart failure * All comfort care orders in the ICU * Patients who underwent tracheostomy
Where this trial is running
Saint Cloud, Minnesota
- St Cloud Hospital — Saint Cloud, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Ramakanth Pata, MD FCCP — Centracare health System
- Study coordinator: Ramakanth Pata, MD FCCP
- Email: cookybrey1@gmail.com
- Phone: 320-240-2207
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.