Early Switch from Controlled to Assisted Ventilation
- Conditions
- Acute Hypoxemic Respiratory FailureMechanical Ventilation
- Interventions
- Other: Pre-specified switch from controlled to assisted ventilation when PaO2/FiO2-ratio > 200 mmHg
- Registration Number
- NCT06438198
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 18 years old
- Written informed consent from a legal representative
- Mechanical ventilation via an endotracheal tube
- Acute hypoxemic respiratory failure with PaO2/FiO2 ratio < 200 mmHg
- Under continuous sedation with or without paralysis
- Expected mechanical ventilation duration of <48 hours
- Pure chronic obstructive pulmonary disease exacerbation
- Pre-existent respiratory muscle disease
- Contraindication to EIT monitoring (as per clinical protocol, e.g. pacemaker, burns or thoracic wounds limiting electrode placement)
- Contra-indications to oesophageal manometry (as per clinical protocol, e.g., recent oesophageal surgery, oesophageal varices, severe bleeding disorders)
- Known pregnancy
- Anticipating withdrawal of life support and/or shift to palliation as the goal of care
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mechanically ventilated adults Pre-specified switch from controlled to assisted ventilation when PaO2/FiO2-ratio > 200 mmHg Switch from controlled to assisted mechanical ventilation when PaO2/FiO2-ratio \> 200 mmHg. Before switch (on controlled ventilation) participants will undergo an electrical impedance tomography (EIT) perfusion measurement as well as a photon-counting CT (PCCT) scan to assess lung perfusion and ventilation/perfusion mismatch. From 15 minutes before until 4 hours after switch and 30 minutes twice daily for 72 hours or until switch failure participants will be monitored continuously using EIT, esophageal pressure and gastric pressure.
- Primary Outcome Measures
Name Time Method Regional lung stress 72 hours The change in regional lung stress as derived from EIT recordings by computing the regional ventilation distribution (ventral-to-dorsal ratio).
- Secondary Outcome Measures
Name Time Method Blood inflammatory biomarkers 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 (%)
Breathing effort 72 hours Time-course of breathing effort during assisted ventilation as measured with esophageal manometry (cmH2O).
Electrical Impedance Tomography (EIT) parameters 72 hours Change in EIT parameters after transition from controlled to assisted ventilation (%)
Electrical Impedance Tomography (EIT)-derived ventilation/perfusion mismatch 30 minutes Ventilation/perfusion mismatch during controlled ventilation measured with EIT
Respiratory mechanics 72 hours Change in respiratory mechanics after transition from controlled to assisted ventilation (cmH2O)
Patient-ventilator asynchrony 72 hours Percentage of asynchronous breaths during assisted ventilation
Gas exchange 72 hours Change in gas exchange after transition from controlled to assisted ventilation (%)
Hemodynamics 72 hours Change in hemodynamics after transition from controlled to assisted ventilation (%)
Breath condensate inflammatory biomarkers 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 (%)
Photon-Counting Computed Tomography (PCCT)-derived ventilation/perfusion mismatch 30 minutes Ventilation/perfusion mismatch during controlled ventilation measured with photon-counting CT scan
Ventilator-free days 28 days Ventilator-free days at day 28
Trial Locations
- Locations (1)
Erasmus MC
🇳🇱Rotterdam, Netherlands