Biphasic Positive Airway Pressure Ventilation Versus Flow-Controlled Ventilation in Burn Patients
Launched by UNIVERSITY HOSPITAL BERGMANNSHEIL BOCHUM · Jun 18, 2025
Trial Information
Current as of June 30, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two different ways to help adults breathe using a ventilator after they have had serious burn injuries. The goal is to find out if a newer method called flow-controlled ventilation (FCV) can protect the lungs better than the standard method, pressure-controlled ventilation (PCV). The researchers want to see if FCV reduces the stress put on the lungs by the ventilator, which can sometimes cause further lung damage. They will compare how much mechanical power (a measure related to lung injury risk) is used during breathing support with each method over about three days.
Adults who have had severe burns and need help breathing with a ventilator shortly after arriving in the burn intensive care unit may be eligible to join. To qualify, patients should weigh at least 40 kg (around 88 pounds), have been on a ventilator for less than 24 hours before arrival or need one within 48 hours of admission, and expect to need ventilation for at least another 24 hours. Participants will be randomly assigned to receive one of the two ventilation methods for up to 70 hours while doctors monitor their lung and organ functions closely. The study will include at least 24 patients and aims to better understand which ventilation type might offer safer breathing support after serious burn injuries.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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
- • Establishment of a central venous line and invasive blood pressure monitoring as part of the intensive care therapy before the intervention start
- • Signed informed consent from the participant, legal guardian, next of kin in incompetent patients, or an intensivist in charge and independent from the Trial Management Committee in incompetent patients without a representative of the patients will
- Exclusion Criteria:
- • 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)
- • Lack of consent from the participant, legal guardian, next of kin, or intensivist in charge to participate in the study
About University Hospital Bergmannsheil Bochum
University Hospital Bergmannsheil Bochum is a leading German medical center affiliated with Ruhr University Bochum, renowned for its comprehensive patient care, advanced medical research, and education. As a prominent clinical trial sponsor, the hospital is dedicated to advancing healthcare through innovative research and the development of new therapies across diverse medical specialties, ensuring high standards of scientific rigor and patient safety.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bochum, , Germany
Patients applied
Trial Officials
Peter K. Zahn, Prof. Dr. med., M.D.
Study Director
Ruhr University Bochum, BG University Hospital Bergmannsheil, Department of Anesthesiology, Intensive Care and Pain Medicine
Simon Becker, Jun.-Prof. Dr. med., M.D.
Principal Investigator
Ruhr University Bochum, BG University Hospital Bergmannsheil, Department of Anesthesiology, Intensive Care and Pain Medicine
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported