Respiratory Failure
Conditions
Brief summary
The study was designed to understand the pathophysiology of gas exchange derangement in critically ill patients with COVID-19. Specifically we will evaluate the effect of 3 different levels of positive end-expiratory pressure (PEEP) and two different levels of inspiratory oxygen fraction (FiO2) on gas exchange by analyzing shunt and dead space. Furthermore, complete respiratory mechanics and distribution of ventilation and perfusion by electrical impedance tomography will be assessed at each level of PEEP.
Interventions
PROCEDUREPEEP trial - Electrical Impedance Tomography
Three different levels of PEEP and two different levels of FiO2 will be tested without changing anything else in the baseline patient ventilation
Sponsors
Policlinico Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients admitted in intensive care unit for COVID-19 related Acute Respiratory Distress Syndrome (ARDS) requiring invasive mechanical ventilation
Exclusion criteria
* Pregnancy * Hemodynamic instability (80-90 mmHg increase or 30-40 mmHg decrease systolic arterial pressure compared to baseline value or need of vasopressors to maintain systolic blood pressure higher than 85 mmHg or electrocardiogram evidence of ischemia/arrhythmias) * Presence of pneumothorax and/or pneumomediastinum * Contraindications to Electrical Impedance Tomography (pacemaker, implantable cardioverter defibrillator, thoracic drainages)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shunt at three different levels of positive end expiratory pressure (PEEP) | 30 minutes after change of positive end expiratory pressure (PEEP) level | Shunt measured by arterial and mixed venous blood samples at each level of PEEP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dead space at three different levels of positive end expiratory pressure (PEEP) | 30 minutes after change of positive end expiratory pressure (PEEP) level | Dead space measured by capnography at each level of PEEP |
| Shunt and dead space at two different levels of inspiratory oxygen fraction for each level of positive end expiratory pressure (PEEP) | 30 minutes after change of positive end expiratory pressure (PEEP) level | Shunt measured by arterial and mixed venous blood samples and dead space measured by capnography at each level of PEEP |
| Ventilation/perfusion at three different levels of positive end expiratory pressure (PEEP) assessed by electrical impedance tomography (EIT) | 30 minutes after change of positive end expiratory pressure (PEEP) level | Ventilation/perfusion assessed by Electrical Impedance Tomography at each level of PEEP |
| Respiratory mechanics at three different levels of positive end expiratory pressure (PEEP) | 30 minutes after change of positive end expiratory pressure (PEEP) level | Respiratory mechanics (including esophageal pressure measurement) assessed at each level of PEEP by performing end-inspiratory and end-expiratory pauses |
Countries
Italy
Outcome results
None listed