Acute Hypoxemic Respiratory Failure, Mechanical Ventilation
Conditions
Keywords
Electrical Impedance Tomography, Esophageal manometry, Controlled Mechanical Ventilation, Assisted Mechanical Ventilation, Respiratory Monitoring
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.
Interventions
OTHERPre-specified switch from controlled to assisted ventilation when PaO2/FiO2-ratio > 200 mmHg
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.
Sponsors
Erasmus Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Electrical Impedance Tomography (EIT) parameters | 72 hours | Change in EIT parameters after transition from controlled to assisted ventilation (%) |
| Photon-Counting Computed Tomography (PCCT)-derived ventilation/perfusion mismatch | 30 minutes | Ventilation/perfusion mismatch during controlled ventilation measured with photon-counting CT scan |
| 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) |
| Breathing effort | 72 hours | Time-course of breathing effort during assisted ventilation as measured with esophageal manometry (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 (%) |
| 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 (%) |
| 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 (%) |
| Ventilator-free days | 28 days | Ventilator-free days at day 28 |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATORAnnemijn Jonkman, PhD
Erasmus Medical Center
Outcome results
None listed