The goal of this clinical trial is to learn if the new ventilation mode flow-controlled ventilation (FCV) is a more protective mode of ventilation for adult patients after severe burn injury. The main question it aims to answer is:
Does FCV reduce the mechanical power (a key determinant of ventilator-induced lung injury) compared to conventional pressure-controlled ventilation (PCV) during ventilation of patients with burn injury?
Researchers will compare FCV with PCV for up to 70 hours of ventilation to see if the mechanical power is reduced during ventilation of participants being in need of ventilation after severe burn injury.
Ventilation of participants will be controlled by either FCV or PCV. Group-specific ventilation will have the following characteristics:
* FCV: Control of airway flows during inspiration and expiration, use of individualized lower and upper airway pressures and no fixed values for the volumes being inspired and expired (tidal volumes) * PCV: No control of airway flows during expiration, use of individualized lower airway pressures and upper airway pressures for a fixed tidal volume during each breath (6-8 ml/kg ideal body weight)
In total, at least 24 participants in need of ventilation after severe burn injury will be ventilated either with FCV (12 participants) or PCV (12 participants) for up to 70 hours.
During ventilation mechanical power is computed according to certain ventilation parameters. Additionally, we evaluate organ functions of the cardiovascular systems, the lungs and other organs during and after the group-specific ventilation.
Body weight ≥ 40 kg
Invasive ventilation time ≤ 24 hours before admission to the burn ICU or indication for intubation and invasive ventilation within 48 hours after admission to the burn ICU
Estimated (further) invasive ventilation time ≥ 24 hours
Intervention start within 48 hours after admission to the burn ICU
Participation in another interventional trial
Duration of invasive ventilation > 24 hours at the time point of admission to the burn ICU
Estimated (further) invasive ventilation time < 24 hours
Patients being treated in the burn ICU for (suspected) severe skin reactions such as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)
Parallel
Individualized flow-controlled ventilation strategy
Other intervention1. Compliance-guided PEEP trial: An incremental PEEP trial from 5 to 15 cmH2O in 2 cmH2O steps with a constant driving pressure (ΔP) will be performed. At the first PEEP level, the tidal volume is set to 6-8 ml/kg PBW. The best PEEP level is defined as the one with the highest dynamic compliance. Participants are ventilated with this PEEP level + 1-2 cmH2O for a reduction of lung de-recruitment and atelectrauma. 2. Compliance-guided driving pressure (ΔP) trial: In the FCV group, an additional incremental ΔP trial in 1 cmH2O steps is initiated after the PEEP trial. This trial evaluates if the tidal volume increases (over-)proportional to the dynamic compliance on the previous ΔP level when the ΔP is increased by 1 cmH2O. In the FCV group, participants are ventilated with a ΔP consistent with the highest dynamic compliance ± 1-2 cmH2O. The compliance-guided PEEP and ΔP trials are repeated every 8 hours in order to account for changes in overall lung compliance.
Pressure-controlled ventilation strategy via the application of Biphasic Positive Airway Pressure ventilation
Other intervention1. Compliance-guided PEEP trial: An incremental PEEP trial from 5 to 15 cmH2O in 2 cmH2O steps with a constant driving pressure (ΔP)will be performed. At the first PEEP level, the tidal volume is set to 6-8 ml/kg PBW. The best PEEP level is defined as the one with the highest dynamic compliance. Participants are ventilated with this PEEP level + 1-2 cmH2O for a reduction of lung de-recruitment and atelectrauma. 2. The driving pressure (ΔP) is set to achieve a tidal volume of 6-8 ml/kg predicted body weight. The compliance-guided PEEP trial is repeated every 8 hours in order to account for changes in overall lung compliance.
Mechanical power
We will compute mechanical power in joules per minute (J/min) hourly according to the surrogate formulae \[Minute ventilation \* (Peak airway pressure + PEEP + Inspiratory flow/6)\]/20 for FCV and 0.098 \* respiratory rate \* tidal volume \* \[PEEP + ΔP\] for PCV/BIPAP
Dissipated energy/power
The hysteresis of the pressure-volume loop represents the dissipated energy in joules, that is dissipated during one ventilation cycle. The dissipated power per unit time can be computed by the respiratory rate per unit time, e.g. Joules per minute (J/min).
Respiratory rate
Respiratory rate per minute
Tidal volume
Tidal volume in ml
Minute volume
Minute volume in liter per minute
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University Hospital Bergmannsheil Bochum
Lead sponsor
Ruhr University of Bochum
Collaborator
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