Burn InjuryBIFLOWBURNNCT07041957
Biphasic Positive Airway Pressure Ventilation Versus Flow-Controlled Ventilation in Burn Patients
A study of Burn Injury and Inhalational Injury, run by University Hospital Bergmannsheil Bochum at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Burn Injury, Inhalational Injury, Pulmonary Complications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
BG University Hospital Bergmannsheil, Ruhr University Bochum
Bochum, 44789
Simon Becker, Jun.-Prof. Dr. med., M.D., +49 234 - 302 6917, simon.becker@rub.de
About this study
Official title: Biphasic Positive Airway Pressure Ventilation Versus Flow-Controlled Ventilation in Burn Patients: A Monocentric, Randomized Controlled, Parallel Group 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?
Read more
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.
Read the detailed description
Invasive ventilation can cause ventilator-induced lung injury. There is growing evidence that high mechanical power during (prolonged) controlled ventilation is associated with ventilator-induced lung injury and pulmonary complications.
Large animal model and perioperative clinical trial data have shown that the individualized application of the flow-controlled ventilation (FCV) mode can reduce mechanical power compared to conventional pressure-controlled ventilation (PCV).
Burn patients with or without inhalational injury are at high risk of pulmonary complications like pneumonias or the acute respiratory distress syndrome due to the hyperinflammatory state and also the intensive care treatment after a burn injury. If these patients need mechanical ventilation, this might aggravate lung injury.
With the study BIFLOWBURN we want to test the hypothesis that the mechanical power during controlled ventilation of burn patients is reduced with the individualized application of FCV compared to conventional PCV via Biphasic Positive Airway Pressure (BIPAP) ventilation.
BIFLOWBURN is a single-center, randomized, parallel-group trial with two intervention arms:
- Controlled BIPAP ventilation (n=12) with a compliance-guided positive end-expiratory pressure (PEEP) and driving pressure (ΔP) for tidal volumes of 6-8 ml/kg predicted body weight compared to
- optimized FCV (n=12) with a compliance-guided PEEP and a compliance-guided ΔP, resulting in liberal tidal volumes.
The group-specific controlled ventilation mode will be applied for a maximum of 70 hours.
As the primary study endpoint, the mechanical power in joules per minute (J/min) is computed during group-specific controlled ventilation.
As secondary study aims, clinically relevant patient outcomes are analyzed as explorative secondary outcomes, e.g., lung function, ventilatory parameters, the incidences of pulmonary and extra-pulmonary complications as well as different intensive care scores for the assessment of organ dysfunctions.
As an additional sub-study with an exploratory approach, parameters of different advanced haemodynamic monitoring techniques are assessed. Within a further ancillary study, biomarkers of acute lung injury and/or the burn inhalational injury will be characterized by molecular biological methods.
BIFLOWBURN is the first randomized controlled trial which assesses mechanical power during the ventilation of burn patients by comparing the alternative mode of flow-controlled ventilation with a conventional ventilation mode.
- Conditions
- Burn Injury, Inhalational Injury, Pulmonary Complications, Ventilator-induced Lung Injury (VILI)
- Being tested
- Individualized flow-controlled ventilation strategy, Pressure-controlled ventilation strategy via the application of Biphasic Positive Airway Pressure ventilation
- Keywords
- Flow-controlled ventilation, Pressure-controlled ventilation, Mechanical Power, Dissipated Energy, Ventilator-induced lung injury
- Medical subject headings
- Burns, Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized flow-controlled ventilation strategyOther
Also called FCV
- 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.
- 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 ventilationOther
Also called PCV via BIPAP
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Flow-Controlled Ventilation | Experimental | Individualized flow-controlled ventilation (FCV) with a compliance-guided positive end-expiratory pressure (PEEP), a compliance-guided driving pressure (ΔP) resulting in a liberal tidal volume, and adjustment of airway flows and respiratory rates being required for normocapnia. Receives: Other: Individualized flow-controlled ventilation strategy |
| Pressure-Controlled Ventilation via Biphasic Positive Airway Pressure Ventilation | Active comparator | Conventional pressure-controlled ventilation via application of Biphasic Positive Airway Pressure (BIPAP) ventilation with a compliance-guided positive end-expiratory pressure (PEEP), a driving pressure (ΔP) for a tidal volume of 6-8 ml/kg predicted body weight, and adjustment of respiratory rates being required for normocapnia but no adjustment/control of airway flows. Receives: Other: Pressure-controlled ventilation strategy via the application of Biphasic Positive Airway Pressure ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Mechanical power will be assessed hourly during up to 70 hours of controlled, group-specific ventilation.
Secondary outcomes (16)
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).
Measured: The dissipated energy/power will be assessed at least hourly/continously during up to 70 hours of controlled, group-specific ventilation.
Respiratory rate
Respiratory rate per minute
Measured: Respiratory rates will be assessed hourly during up to 70 hours of controlled, group-specific ventilation.
Tidal volume
Tidal volume in ml
Measured: Tidal volumes will be assessed hourly during up to 70 hours of controlled, group-specific ventilation.
Minute volume
Minute volume in liter per minute
Measured: Minute volumes will be assessed hourly during up to 70 hours of controlled, group-specific ventilation.
Airway pressures
Airway pressures like positive end-expiratory pressure (PEEP), peak airway pressure, driving pressure (ΔP) and mean airway pressure in cmH2O
Measured: Airway pressures will be assessed hourly during up to 70 hours of controlled, group-specific ventilation.
Dynamic compliance
Dynamic compliance in ml per cmH2O will be calculated according to the formula tidal volume/driving pressure.
Measured: Dynamic compliances will be assessed hourly during up to 70 hours of controlled, group-specific ventilation.
Airway resistance
Airway resistance in cmH2O/L/s as displayed on the ventilator.
Measured: Airway resistances will be assessed hourly during up to 70 hours of controlled, group-specific ventilation.
Oxygenation indices
Computed as partial pressure of arterial oxygen/inspired oxygen fraction
Measured: Oxygenation indices will be assessed every 4-8 hours with arterial blood gas analyses during up to 70 hours of controlled, group-specific ventilation.
Pulmonary complications
Incidence of pulmonary complications including but not limited to need for non-invasive ventilation / high flow nasal cannula therapy, reintubation, tracheotomy, prone positioning, ARDS, pleural effusions, pneumothorax, bronchoscopy, suspected or confirmed pneumonia
Measured: Pulmonary complications will be assessed within the first ten days after randomization.
Extra-pulmonary complications
Incidence of extra-pulmonary complications including but not limited to systemic inflammatory response syndrome (SIRS), sepsis, septic shock, new arrythmias, cardiac arrest, infection other than pneumonia treated with antibiotics, delirium, acute kidney injury
Measured: Extra-pulmonary complications will be assessed within the first ten days after randomization.
Sequential Organ Failure Assessment (SOFA) Score
The Sequential Organ Failure Assessment (SOFA) Score ranges from zero (no organ failure present) to 24 (most severe failure in all assessed organ systems).
Measured: The Sequential Organ Failure Assessment (SOFA) Score will be assessed daily within the first ten days after randomization.
Lung Injury Score (Murray)
The Murray Score for Acute Lung Injury is ranging from zero (no lung injury) to 16 (most severe lung injury).
Measured: The Lung Injury Score will be assessed daily within the first ten days after randomization.
Acute Physiology and Chronic Health Evaluation (APACHE) Score
The Acute Physiology and Chronic Health Evaluation (APACHE) Score provides an estimate of in-hospital ICU mortality with lower score values being associated with a lower mortality rate and higher score values being associated with a higher mortality rate.
Measured: The Acute Physiology and Chronic Health Evaluation (APACHE) Score will be assessed daily within the first ten days after randomization.
Duration of invasive ventilation
The total length of invasive ventilation will be assessed in minutes.
Measured: Participants will be followed-up on length of invasive ventilation for 6 months after the interventions.
Length of stay
Participant will be monitored on ICU and hospital length of stay in days.
Measured: Participants will be followed-up for 6 months after the interventions.
Mortality
Mortality of participants will be monitored up to 6 months after the interventions.
Measured: Participants will be followed-up for 6 months after the interventions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study startJul 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Burn InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Bergmannsheil Bochum
- Sponsor type
- University, hospital or other
- Collaborators
- Ruhr University of Bochum, Department of Anesthesiology, Intensive Care, Pain and Palliative Care, Marien Hospital Herne, Ruhr University Bochum, Bochum, Germany
- Responsible party
- Principal investigator, Simon Becker, University Hospital Bergmannsheil Bochum
- Investigators
- Peter K. Zahn, Prof. Dr. med., M.D., Study director, Ruhr University Bochum, BG University Hospital Bergmannsheil, Department of Anesthesiology, Intensive Care and Pain MedicineSimon Becker, Jun.-Prof. Dr. med., M.D., Principal investigator, Ruhr University Bochum, BG University Hospital Bergmannsheil, Department of Anesthesiology, Intensive Care and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041957
- Sponsor's protocol ID
- 23-7944
- Other IDs
- 23-7944
- Acronym
- BIFLOWBURN
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Before the enrolment of the last participant, the study protocol including the statistical analysis plan will be published in an appropriate journal after peer-reviewing. After pseudonymisation, data is transferred and processed with the web-based application software REDCap™. This enables data sharing of complete deidentified data sets of all primary and secondary study outcome data with the scientific community upon personal request with a reasonable proposal to the principal investigator.
Publications
Bittner E, Sheridan R. Acute Respiratory Distress Syndrome, Mechanical Ventilation, and Inhalation Injury in Burn Patients. Surg Clin North Am. 2023 Jun;103(3):439-451. doi: 10.1016/j.suc.2023.01.006. Epub 2023 Mar 21.
PubMed 37149380Van Oosten JP, Francovich JE, Somhorst P, van der Zee P, Endeman H, Gommers DAMPJ, Jonkman AH. Flow-controlled ventilation decreases mechanical power in postoperative ICU patients. Intensive Care Med Exp. 2024 Mar 19;12(1):30. doi: 10.1186/s40635-024-00616-9.
PubMed 38502268Spraider P, Abram J, Martini J, Putzer G, Glodny B, Hell T, Barnes T, Enk D. Flow-controlled versus pressure-controlled ventilation in cardiac surgery with cardiopulmonary bypass - A single-center, prospective, randomized, controlled trial. J Clin Anesth. 2023 Dec;91:111279. doi: 10.1016/j.jclinane.2023.111279. Epub 2023 Oct 3.
PubMed 37797394Abram J, Martini J, Spraider P, Putzer G, Ranalter M, Wagner J, Glodny B, Hell T, Barnes T, Enk D. Individualised flow-controlled versus pressure-controlled ventilation in a porcine oleic acid-induced acute respiratory distress syndrome model. Eur J Anaesthesiol. 2023 Jul 1;40(7):511-520. doi: 10.1097/EJA.0000000000001807. Epub 2023 Feb 7.
PubMed 36749046Urner M, Juni P, Hansen B, Wettstein MS, Ferguson ND, Fan E. Time-varying intensity of mechanical ventilation and mortality in patients with acute respiratory failure: a registry-based, prospective cohort study. Lancet Respir Med. 2020 Sep;8(9):905-913. doi: 10.1016/S2213-2600(20)30325-8. Epub 2020 Jul 28.
PubMed 32735841Santer P, Wachtendorf LJ, Suleiman A, Houle TT, Fassbender P, Costa EL, Talmor D, Eikermann M, Baedorf-Kassis E, Schaefer MS. Mechanical Power during General Anesthesia and Postoperative Respiratory Failure: A Multicenter Retrospective Cohort Study. Anesthesiology. 2022 Jul 1;137(1):41-54. doi: 10.1097/ALN.0000000000004256.
PubMed 35475882Cressoni M, Gotti M, Chiurazzi C, Massari D, Algieri I, Amini M, Cammaroto A, Brioni M, Montaruli C, Nikolla K, Guanziroli M, Dondossola D, Gatti S, Valerio V, Vergani GL, Pugni P, Cadringher P, Gagliano N, Gattinoni L. Mechanical Power and Development of Ventilator-induced Lung Injury. Anesthesiology. 2016 May;124(5):1100-8. doi: 10.1097/ALN.0000000000001056.
PubMed 26872367
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biphasic Positive Airway Pressure Ventilation Versus Flow-Controlled Ventilation in Burn Patients: A Monocentric, Randomized Controlled, Parallel Group Trial
- ClinicalTrials.gov ID
- NCT07041957
- Acronym / sponsor ID
- BIFLOWBURN / 23-7944
- Conditions
- Burn Injury, Inhalational Injury, Pulmonary Complications, Ventilator-induced Lung Injury (VILI)
- Keywords
- Flow-controlled ventilation, Pressure-controlled ventilation, Mechanical Power, Dissipated Energy, Ventilator-induced lung injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital Bergmannsheil BochumUniversity, hospital or other
- Collaborators
- Ruhr University of Bochum, Department of Anesthesiology, Intensive Care, Pain and Palliative Care, Marien Hospital Herne, Ruhr University Bochum, Bochum, Germany
- Study start
- Jul 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Invasive ventilation can cause ventilator-induced lung injury. There is growing evidence that high mechanical power during (prolonged) controlled ventilation is associated with ventilator-induced lung injury and pulmonary complications.
Large animal model and perioperative clinical trial data have shown that the individualized application of the flow-controlled ventilation (FCV) mode can reduce mechanical power compared to conventional pressure-controlled ventilation (PCV).
Burn patients with or without inhalational injury are at high risk of pulmonary complications like pneumonias or the acute respiratory distress syndrome due to the hyperinflammatory state and also the intensive care treatment after a burn injury. If these patients need mechanical ventilation, this might aggravate lung injury.
With the study BIFLOWBURN we want to test the hypothesis that the mechanical power during controlled ventilation of burn patients is reduced with the individualized application of FCV compared to conventional PCV via Biphasic Positive Airway Pressure (BIPAP) ventilation.
BIFLOWBURN is a single-center, randomized, parallel-group trial with two intervention arms:
- Controlled BIPAP ventilation (n=12) with a compliance-guided positive end-expiratory pressure (PEEP) and driving pressure (ΔP) for tidal volumes of 6-8 ml/kg predicted body weight compared to
- optimized FCV (n=12) with a compliance-guided PEEP and a compliance-guided ΔP, resulting in liberal tidal volumes.
The group-specific controlled ventilation mode will be applied for a maximum of 70 hours.
As the primary study endpoint, the mechanical power in joules per minute (J/min) is computed during group-specific controlled ventilation.
As secondary study aims, clinically relevant patient outcomes are analyzed as explorative secondary outcomes, e.g., lung function, ventilatory parameters, the incidences of pulmonary and extra-pulmonary complications as well as different intensive care scores for the assessment of organ dysfunctions.
As an additional sub-study with an exploratory approach, parameters of different advanced haemodynamic monitoring techniques are assessed. Within a further ancillary study, biomarkers of acute lung injury and/or the burn inhalational injury will be characterized by molecular biological methods.
BIFLOWBURN is the first randomized controlled trial which assesses mechanical power during the ventilation of burn patients by comparing the alternative mode of flow-controlled ventilation with a conventional ventilation mode.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flow-Controlled Ventilation | Experimental | Other: Individualized flow-controlled ventilation strategyIndividualized flow-controlled ventilation (FCV) with a compliance-guided positive end-expiratory pressure (PEEP), a compliance-guided driving pressure (ΔP) resulting in a liberal tidal volume, and adjustment of airway flows and respiratory rates being required for normocapnia. |
| Pressure-Controlled Ventilation via Biphasic Positive Airway Pressure Ventilation | Active comparator | Other: Pressure-controlled ventilation strategy via the application of Biphasic Positive Airway Pressure ventilationConventional pressure-controlled ventilation via application of Biphasic Positive Airway Pressure (BIPAP) ventilation with a compliance-guided positive end-expiratory pressure (PEEP), a driving pressure (ΔP) for a tidal volume of 6-8 ml/kg predicted body weight, and adjustment of respiratory rates being required for normocapnia but no adjustment/control of airway flows. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized flow-controlled ventilation strategyAlso: FCV1. 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. | Other | Flow-Controlled Ventilation |
| Pressure-controlled ventilation strategy via the application of Biphasic Positive Airway Pressure ventilationAlso: PCV via BIPAP1. 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. | Other | Pressure-Controlled Ventilation via Biphasic Positive Airway Pressure Ventilation |
Primary outcome
Mechanical power
Time frame: Mechanical power will be assessed hourly during up to 70 hours of controlled, group-specific ventilation.
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
16 secondary outcomes
Dissipated energy/power
Time frame: The dissipated energy/power will be assessed at least hourly/continously during up to 70 hours of controlled, group-specific ventilation.
Respiratory rate
Time frame: Respiratory rates will be assessed hourly during up to 70 hours of controlled, group-specific ventilation.
Tidal volume
Time frame: Tidal volumes will be assessed hourly during up to 70 hours of controlled, group-specific ventilation.
Minute volume
Time frame: Minute volumes will be assessed hourly during up to 70 hours of controlled, group-specific ventilation.
Airway pressures
Time frame: Airway pressures will be assessed hourly during up to 70 hours of controlled, group-specific ventilation.
Dynamic compliance
Time frame: Dynamic compliances will be assessed hourly during up to 70 hours of controlled, group-specific ventilation.
Airway resistance
Time frame: Airway resistances will be assessed hourly during up to 70 hours of controlled, group-specific ventilation.
Oxygenation indices
Time frame: Oxygenation indices will be assessed every 4-8 hours with arterial blood gas analyses during up to 70 hours of controlled, group-specific ventilation.
Pulmonary complications
Time frame: Pulmonary complications will be assessed within the first ten days after randomization.
Extra-pulmonary complications
Time frame: Extra-pulmonary complications will be assessed within the first ten days after randomization.
Sequential Organ Failure Assessment (SOFA) Score
Time frame: The Sequential Organ Failure Assessment (SOFA) Score will be assessed daily within the first ten days after randomization.
Lung Injury Score (Murray)
Time frame: The Lung Injury Score will be assessed daily within the first ten days after randomization.
Acute Physiology and Chronic Health Evaluation (APACHE) Score
Time frame: The Acute Physiology and Chronic Health Evaluation (APACHE) Score will be assessed daily within the first ten days after randomization.
Duration of invasive ventilation
Time frame: Participants will be followed-up on length of invasive ventilation for 6 months after the interventions.
Length of stay
Time frame: Participants will be followed-up for 6 months after the interventions.
Mortality
Time frame: Participants will be followed-up for 6 months after the interventions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Results publication: PubMed 37149380Bittner E, Sheridan R. Acute Respiratory Distress Syndrome, Mechanical Ventilation, and Inhalation Injury in Burn Patients. Surg Clin North Am. 2023 Jun;103(3):439-451. doi: 10.1016/j.suc.2023.01.006. Epub 2023 Mar 21.
- Results publication: PubMed 38502268Van Oosten JP, Francovich JE, Somhorst P, van der Zee P, Endeman H, Gommers DAMPJ, Jonkman AH. Flow-controlled ventilation decreases mechanical power in postoperative ICU patients. Intensive Care Med Exp. 2024 Mar 19;12(1):30. doi: 10.1186/s40635-024-00616-9.
- Results publication: PubMed 37797394Spraider P, Abram J, Martini J, Putzer G, Glodny B, Hell T, Barnes T, Enk D. Flow-controlled versus pressure-controlled ventilation in cardiac surgery with cardiopulmonary bypass - A single-center, prospective, randomized, controlled trial. J Clin Anesth. 2023 Dec;91:111279. doi: 10.1016/j.jclinane.2023.111279. Epub 2023 Oct 3.
- Results publication: PubMed 36749046Abram J, Martini J, Spraider P, Putzer G, Ranalter M, Wagner J, Glodny B, Hell T, Barnes T, Enk D. Individualised flow-controlled versus pressure-controlled ventilation in a porcine oleic acid-induced acute respiratory distress syndrome model. Eur J Anaesthesiol. 2023 Jul 1;40(7):511-520. doi: 10.1097/EJA.0000000000001807. Epub 2023 Feb 7.
- Results publication: PubMed 32735841Urner M, Juni P, Hansen B, Wettstein MS, Ferguson ND, Fan E. Time-varying intensity of mechanical ventilation and mortality in patients with acute respiratory failure: a registry-based, prospective cohort study. Lancet Respir Med. 2020 Sep;8(9):905-913. doi: 10.1016/S2213-2600(20)30325-8. Epub 2020 Jul 28.
- Results publication: PubMed 35475882Santer P, Wachtendorf LJ, Suleiman A, Houle TT, Fassbender P, Costa EL, Talmor D, Eikermann M, Baedorf-Kassis E, Schaefer MS. Mechanical Power during General Anesthesia and Postoperative Respiratory Failure: A Multicenter Retrospective Cohort Study. Anesthesiology. 2022 Jul 1;137(1):41-54. doi: 10.1097/ALN.0000000000004256.
- Results publication: PubMed 26872367Cressoni M, Gotti M, Chiurazzi C, Massari D, Algieri I, Amini M, Cammaroto A, Brioni M, Montaruli C, Nikolla K, Guanziroli M, Dondossola D, Gatti S, Valerio V, Vergani GL, Pugni P, Cadringher P, Gagliano N, Gattinoni L. Mechanical Power and Development of Ventilator-induced Lung Injury. Anesthesiology. 2016 May;124(5):1100-8. doi: 10.1097/ALN.0000000000001056.
- Individual participant dataSharing planned: Yes. Before the enrolment of the last participant, the study protocol including the statistical analysis plan will be published in an appropriate journal after peer-reviewing. After pseudonymisation, data is transferred and processed with the web-based application software REDCap™. This enables data sharing of complete deidentified data sets of all primary and secondary study outcome data with the scientific community upon personal request with a reasonable proposal to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Burn Injury and Inhalational Injury, run by University Hospital Bergmannsheil Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon Becker, Jun.-Prof. Dr. med., M.D. (+49 234 - 302 6917, simon.becker@rub.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical power (time frame: Mechanical power will be assessed hourly during up to 70 hours of controlled, group-specific ventilation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07041957, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.