University Health Network
Toronto, Ontario, M5G 2N2, Canada
NCT Number: NCT03589482
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, M5G 2N2, Canada
Patients participating in this physiological cross-over randomized trial will undergo a series of PEEP maneuvers designed to assess lung recruitability, PEEP responsiveness, and optimal PEEP. EIT imaging and esophageal manometry will be employed throughout the protocol to quantify the effect of PEEP on lung function. Patients will be randomized to be ventilated at PEEP levels supplied by the ExPRESS strategy or by the EIT hyperdistention/collapse algorithm. The biological response will be assessed by measuring serum cytokines.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Electrical impedance tomography (EIT) is a new technique that enables real-time visualization of the distribution of ventilation at the bedside. This technique allows clinicians and investigators to immediately determine how applying higher or lower PEEP levels affect stress and strain in the lung. The investigators propose to apply this new technique to test a strategy for finding the optimal level of PEEP that prevents lung injury and improves outcomes in critically ill patients.
The ExPRESS algorithm is a traditional approach to selecting PEEP based on respiratory mechanics.
Time frame: Assessed after completion of 3 hours on randomized strategy (EIT vs ExPRESS)
A measure of variation in the distribution of ventilation throughout the lung as detected by electrical impedance tomography
Time frame: Assessed immediately after completion of decremental PEEP titration procedure
Compare the relative degree of agreement or disparity between PEEP levels recommended by different PEEP titration strategies
Time frame: Assessed 10 minutes after step PEEP increase from 6-8 to 16-18 cm H2O
Measurement of changes in oxygenation by PaO2/FiO2 ratio due to PEEP
Time frame: Assessed after completing 3 hours on the randomized PEEP strategy (EIT vs ExPRESS)
The swing in transpulmonary pressure during inspiration, a measure of dynamic lung stress
University Health Network, Toronto
Other
Acronym: ALIVE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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