University Health Network
Toronto, Ontario, M5G 2N2, Canada
NCT Number: NCT03612583
This study is designed to test a proposed strategy for lung- and diaphragm-protective ventilation (LDPV) in patients with acute hypoxemic respiratory failure. Ventilation and sedation will be titrated to evaluate whether it is feasible and safe within this patient population.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Toronto, Ontario, M5G 2N2, Canada
Lung injury and diaphragm injury incurred by mechanical ventilation have very serious adverse effects on patients with acute respiratory failure. Lung injury results from excessive mechanical stress and strain applied to the lung by the ventilator and/or respiratory muscles, while diaphragm injury results from either insufficient or excessive inspiratory effort.
The objective of this study is to investigate a new LDPV strategy designed to prevent both disuse-mediated and load-induced diaphragm injury, while also preventing excess global and regional mechanical stress and strain in the injured lung. To achieve these goals, the following specific targets to be met are: (1) respiratory muscle effort similar to that of healthy subjects breathing at rest, (2) lung stress within safe limits, and (3) clinically acceptable gas exchange.
Targets are assessed through measurements of global lung stress, tidal recruitment, inspiratory effort, diaphragm contractile effort and adequacy of respiratory muscle and systemic tissue perfusion. Measurements commence at enrollment and continue for 24 hours consecutively.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ventilation and sedation will be progressively modified according to the LDPV algorithm to achieve targets. Patients will be crossed-over to the opposite PEEP strategy. LDPV titration will then be repeated to achieve LDPV targets. After establishing a combination of ventilation and sedation settings at which LDPV targets are achieved, the targets will be maintained over a 24-hour period.
Other names: LDPV
Time frame: Assessed after achievement of LDPV targets for 24 hours
Time frame: Assessed 10 minutes after PEEP and sedation are adjusted
Time frame: Assessed 10 minutes after PEEP and sedation are adjusted
Time frame: Assessed 10 minutes after PEEP and sedation are adjusted
Time frame: Assessed 10 minutes after PEEP and sedation are adjusted
Time frame: Assessed 10 minutes after PEEP and sedation are adjusted
Time frame: Assessed after completing the 24-hour maintenance period
We will compare the model's prediction of patient's esophageal pressure, pH and transpulmonary pressure to the actual observed values
University Health Network, Toronto
Other
Acronym: LANDMARK
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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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