Assessing Lung Inhomogeneity During Ventilation for Acute Hypoxemic Respiratory Failure (NCT03589482) | Clinical Trial Compass
CompletedNot Applicable
Assessing Lung Inhomogeneity During Ventilation for Acute Hypoxemic Respiratory Failure
Canada20 participantsStarted 2019-03-01
Plain-language summary
Mechanical ventilation can cause damage by overstretching the lungs, especially when the lungs are collapsed or edematous. Raising ventilator pressures can reduce lung collapse and this can prevent overstretching from mechanical ventilation. It remains uncertain how much pressure (PEEP - positive end-expiratory pressure) should be used on the ventilator and how to identify patients who will benefit from higher ventilator pressures vs. lower ventilator pressures. The investigators are using a unique new imaging technology, electrical impedance tomography (EIT), to study this problem and to determine the safest and most effective ventilator pressure level. The results of this study will inform future trials of higher vs. lower PEEP strategies in mechanically ventilated patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Acute (≤7 days) hypoxemia with PaO2:FiO2 ratio less than or equal to 200 mm Hg
* Oral endotracheal intubation and mechanical ventilation
* Bilateral airspace opacities on chest radiograph or CT
Exclusion Criteria:
* Contraindication to EIT electrode placement (burns, chest wall bandaging limiting electrode placement)
* Contraindication to esophageal catheter placement (recent upper GI surgery, actively bleeding esophageal varices)
* Respiratory failure predominantly due to cardiogenic cause or fluid overload
* Ongoing hemodynamic instability (requiring 2 vasopressor agents by continuous infusion AND rising vasopressor infusion rate requirements in the previous 8 hours)
* Ongoing ventilatory instability (P/F \< 70 mm Hg, pH \< 7.2; ventilator driving pressures, PEEP, or FiO2 increasing by more than 25% in previous 30 minutes)
* Intracranial hypertension (suspected or diagnosed by medical team)
* Known or suspected pneumothorax recognized within previous 72 hours
* Bronchopleural fistula
* Bridge to lung transplant
* Recent lung transplantation (within previous 6 weeks)
* Attending physician deems the transient application of high airway pressures (\>40 cm H2O) to be unsafe
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intratidal ventilation heterogeneity
Timeframe: Assessed after completion of 3 hours on randomized strategy (EIT vs ExPRESS)