Erasmus MC
Rotterdam, Netherlands
NCT Number: NCT06438198
The goal of this physiological intervention study is to unravel the (patho)physiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure (PaO2/FiO2 ratio < 200 mmHg).
The intervention is that participants will be switched from controlled to assisted ventilation when PaO2/FiO2 ratio > 200 mmHg.
The primary endpoint is the change in regional lung stress (as derived by electrical impedance tomography) when switching from controlled to assisted ventilation and until a successful or failed switch.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Rotterdam, Netherlands
A crucial milestone in the trajectory of the mechanically ventilated patient is the switch from fully controlled mechanical ventilation to assisted ventilation. This switch should be made as early as feasible and safe, to limit the detrimental effects from prolonged controlled ventilation and sedation. However, there is also indirect evidence that excessive breathing effort during assisted ventilation may worsen lung injury (P-SILI). There are no guidelines that address this important switch moment.
Therefore, the overall aim of this physiological intervention study is to unravel the (patho)physiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure (PaO2/FiO2 ratio < 200 mmHg).
Participants will be switched from controlled to assisted ventilation switch when PaO2/FiO2 ratio > 200 mmHg and will be monitored continuously using electrical impedance tomography, and oesophageal and gastric pressure until 4 hours post-switch and twice daily for 72 hours or until switch failure (switch back to controlled ventilation within 72 hours).
The primary endpoint is the change in regional lung stress (as derived by electrical impedance tomography) when switching from controlled to assisted ventilation and until a successful or failed switch.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A pre-specified switch from controlled to assisted ventilation will be initiated when PaO2/FiO2-ratio > 200 mmHg. The moment of switch is pre-specified but patient management and ventilator settings are up to the clinical team. Switch is complete when the patient triggers all breaths spontaneously. Switch success is defined if patient reaches 72 hours on assisted ventilation. Switch failure is defined if patient switches back to controlled ventilation for more than 2 hours before 72 hours.
Time frame: 72 hours
The change in regional lung stress as derived from EIT recordings by computing the regional ventilation distribution (ventral-to-dorsal ratio).
Time frame: 72 hours
Change in EIT parameters after transition from controlled to assisted ventilation (%)
Time frame: 30 minutes
Ventilation/perfusion mismatch during controlled ventilation measured with photon-counting CT scan
Time frame: 30 minutes
Ventilation/perfusion mismatch during controlled ventilation measured with EIT
Time frame: 72 hours
Change in respiratory mechanics after transition from controlled to assisted ventilation (cmH2O)
Time frame: 72 hours
Time-course of breathing effort during assisted ventilation as measured with esophageal manometry (cmH2O).
Time frame: 72 hours
Percentage of asynchronous breaths during assisted ventilation
Time frame: 72 hours
Change in gas exchange after transition from controlled to assisted ventilation (%)
Time frame: 72 hours
Change in hemodynamics after transition from controlled to assisted ventilation (%)
Time frame: 72 hours
Blood biomarkers concentrations including cytokines and chemokines (i.e., interleukins, TNF-alpha, MCP-1 and MIP-1beta, CD14) measured as the difference between baseline vs. 72h (%)
Time frame: 72 hours
Swivel-derived exhaled-breath condensate biomarkers concentrations including cytokines and chemokines (i.e., interleukins, TNF-alpha, MCP-1 and MIP-1beta, CD14) measured as the difference between baseline vs. 72h (%)
Time frame: 28 days
Ventilator-free days at day 28
Erasmus Medical Center
Other
Unraveling the (Patho)Physiological Mechanisms and Potential Clinical Benefits of an Early Switch From Controlled to Assisted Ventilation
Acronym: SWITCH-SAFE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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