Biphasic Positive Airway Pressure Ventilation Versus Flow-Controlled Ventilation in Burn Patients
NCT ID: NCT07041957
Last Updated: 2025-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
24 participants
INTERVENTIONAL
2025-07-31
2028-06-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Flow-Controlled Ventilation
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.
Individualized flow-controlled ventilation strategy
1. 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 via Biphasic Positive Airway Pressure Ventilation
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.
Pressure-controlled ventilation strategy via the application of Biphasic Positive Airway Pressure ventilation
1. 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.
Interventions
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Individualized flow-controlled ventilation strategy
1. 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
1. 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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Department of Plastic, Reconstructive and Burn Surgery, BG University Hospital Bergmannsheil, Ruhr University Bochum, Bochum, Germany
UNKNOWN
Department of Medical Informatics, Biometry and Epidemiology, Ruhr University Bochum, Bochum, Germany
UNKNOWN
Medical Proteom-Center (MPC), Ruhr University Bochum, Bochum, Germany
UNKNOWN
Department of Anesthesiology, Intensive Care and Pain Medicine, BG University Hospital Bergmannsheil, Ruhr University Bochum
UNKNOWN
Department of Anesthesiology, Intensive Care, Pain and Palliative Care, Marien Hospital Herne, Ruhr University Bochum, Bochum, Germany
UNKNOWN
University Hospital Bergmannsheil Bochum
OTHER
Responsible Party
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Simon Becker
Jun.-Prof. Dr. med. Simon Becker, M.D.
Principal Investigators
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Peter K. Zahn, Prof. Dr. med., M.D.
Role: 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.
Role: PRINCIPAL_INVESTIGATOR
Ruhr University Bochum, BG University Hospital Bergmannsheil, Department of Anesthesiology, Intensive Care and Pain Medicine
Locations
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BG University Hospital Bergmannsheil, Ruhr University Bochum
Bochum, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Van 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.
Spraider 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.
Abram 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.
Urner 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.
Santer 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.
Cressoni 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.
Other Identifiers
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23-7944
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
23-7944
Identifier Type: -
Identifier Source: org_study_id
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