Biphasic Positive Airway Pressure Ventilation Versus Flow-Controlled Ventilation in Burn Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital Bergmannsheil Bochum

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

24 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital Bergmannsheil Bochum

Lead sponsor

Ruhr University of Bochum

Collaborator