None listed
Conditions
Brief summary
AIM The primary aim of this study is to determine whether use of adaptive ventilation mode (AVM2) which uses an automated mechanical power algorithm leads to a decrease in driving pressure in patients with moderate to severe ARDS. HYPOTHESIS We hypothesized that, when compared to “traditional” Lung protective mechanical ventilation based on low tidal volume ventilation, ventilator settings selected by AVM2 will have a lower driving pressure DESIGN A single centre feasibility / physiological / proof of concept study in 20 ARDS patients within 24 hours of intubation (moderate to severe ARDS). Study design will be a prospective randomized cross-over study in 20 critically ill patients on controlled mechanical ventilation- with randomized 6 hours of LTV and 6 hours of AVM2. Study period 2 years Setting Single Centre study conducted in the Intensive care unit (ICU) at Flinders Medical Centre, Australia Population Inclusion: who are 'greater than and equal to' 18 years of age, intubated, and within 48h of a diagnosis of moderate/severe ARDS (PaO2/FiO2 <= 200 mmHg, PEEP >= 5 cm H2O, bilateral opacities on chest X-ray and respiratory failure not fully explained by cardiac failure or fluid overload) Exclusion: patients with active bronchospasm or a history of significant chronic obstructive pulmonary disease or asthma, lack of consent (treating physician or next of kin), inevitable and imminent death, pregnancy, those receiving ECMO, or involvement in other prospective clinical studies. Intervention AVM2 which uses an automated mechanical power algorithm. Comparator Usual care, with a tidal volume-based approach as per the ARDSnet protocol Sample size 20 patient – feasibility study STUDY ENDPOINTS Outcomes The Primary outcome is driving pressure. Other secondary outcomes will include delivered tidal volume, mechanical power, PaO2/FiO2 ratio, PaCO2, pH, lung dead space and patients hemodynamic (hemodynamic data on MAP and HR were averaged during the last 5 min of each hour of the 6-h period)
Interventions
Before study inclusion, all patients will be ventilated with lung protective volume control ventilation (LTV). After obtaining informed consent, patients will be randomized in a 1:1 ratio to one of two groups: group I “LTV-AVM2”, first ventilated according to low tidal volume ventilation and then according to “minimized inspiratory power” with (adaptive ventilation mode 2 (AVM2), or group II “AVM2- LTV”, ventilated with both modes in the reversed order. After 6 hours, patients previously ventila
Before study inclusion, all patients will be ventilated with lung protective volume control ventilation (LTV). After obtaining informed consent, patients will be randomized in a 1:1 ratio to one of two groups: group I “LTV-AVM2”, first ventilated according to low tidal volume ventilation and then according to “minimized inspiratory power” with (adaptive ventilation mode 2 (AVM2), or group II “AVM2- LTV”, ventilated with both modes in the reversed order. After 6 hours, patients previously ventilated with LTV were switched to AVM2 and vice versa." LTV will based on the current standard of lung protective volume control ventilation at 6ml/kg while the AVM2 will dynamic and will be based to minimize inspiratory power Duration will be 6 hours for each mode This will be done by the bed side ICU consultant Adherence will be monitored by the ventilator and medical records
Sponsors
Flinders Medical Centre ICU
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
who were greater than equal to 18 years of age, intubated, and within 48h of a diagnosis of moderate/severe ARDS (PaO2/FiO2 less than or equal to 200 mmHg, PEEP more than or equal to 5 cm H2O, bilateral opacities on chest X-ray and respiratory failure not fully explained by cardiac failure or fluid overload)
Exclusion criteria
patients with active bronchospasm or a history of significant chronic obstructive pulmonary disease or asthma, lack of consent (treating physician or next of kin), inevitable and imminent death, pregnancy, those receiving ECMO, or involvement in other prospective clinical studies.
Outcome results
None listed