About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Individualized flow-controlled ventilation strategy
- Pressure-controlled ventilation strategy via the application of Biphasic Positive Airway Pressure ventilation
Treatment groups
Sponsors and collaborators
University Hospital Bergmannsheil Bochum
Lead sponsor
Ruhr University of Bochum
Collaborator