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

NCT07041957 | Not Yet Recruiting

• 1 other identifier: 23-7944
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  Mechanical power will be assessed hourly during up to 70 hours of controlled, group-specific ventilation.

Secondary Outcomes (16)

• Dissipated energy/power

  The dissipated energy/power will be assessed at least hourly/continously during up to 70 hours of controlled, group-specific ventilation.

• Respiratory rate

  Respiratory rates will be assessed hourly during up to 70 hours of controlled, group-specific ventilation.

• Tidal volume

  Tidal volumes will be assessed hourly during up to 70 hours of controlled, group-specific ventilation.

• Minute volume

  Minute volumes will be assessed hourly during up to 70 hours of controlled, group-specific ventilation.

• Airway pressures

  Airway pressures will be assessed hourly during up to 70 hours of controlled, group-specific ventilation.

Study Arms (2)

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.

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.

Other: Pressure-controlled ventilation strategy via the application of Biphasic Positive Airway Pressure ventilation

Interventions

Individualized flow-controlled ventilation strategy OTHER

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.

Also known as: FCV

Flow-Controlled Ventilation

Pressure-controlled ventilation strategy via the application of Biphasic Positive Airway Pressure ventilation OTHER

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.

Also known as: PCV via BIPAP

Pressure-Controlled Ventilation via Biphasic Positive Airway Pressure Ventilation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Bergmannsheil Bochum: lead
• Department of Plastic, Reconstructive and Burn Surgery, BG University Hospital Bergmannsheil, Ruhr University Bochum, Bochum, Germany: collaborator
• Department of Medical Informatics, Biometry and Epidemiology, Ruhr University Bochum, Bochum, Germany: collaborator
• Medical Proteom-Center (MPC), Ruhr University Bochum, Bochum, Germany: collaborator
• Department of Anesthesiology, Intensive Care and Pain Medicine, BG University Hospital Bergmannsheil, Ruhr University Bochum: collaborator
• Department of Anesthesiology, Intensive Care, Pain and Palliative Care, Marien Hospital Herne, Ruhr University Bochum, Bochum, Germany: collaborator

Study Sites (1)

BG University Hospital Bergmannsheil, Ruhr University Bochum

Bochum, 44789, Germany

Location

Related Publications (7)

• 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.

  PMID: 37149380 BACKGROUND

• 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.

  PMID: 38502268 BACKGROUND

• 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.

  PMID: 37797394 BACKGROUND

• 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.

  PMID: 36749046 BACKGROUND

• 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.

  PMID: 32735841 BACKGROUND

• 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.

  PMID: 35475882 BACKGROUND

• 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.

  PMID: 26872367 BACKGROUND

MeSH Terms

Conditions

Burns; Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Wounds and Injuries; Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Peter K. Zahn, Prof. Dr. med., M.D.

  Ruhr University Bochum, BG University Hospital Bergmannsheil, Department of Anesthesiology, Intensive Care and Pain Medicine

  STUDY DIRECTOR

• Simon Becker, Jun.-Prof. Dr. med., M.D.

  Ruhr University Bochum, BG University Hospital Bergmannsheil, Department of Anesthesiology, Intensive Care and Pain Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Becker, Jun.-Prof. Dr. med., M.D.

CONTACT

+49 234 - 302 6917; simon.becker@rub.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Due to different ventilators during the interventions, outcome assessors can only be blinded after intervention withdrawal. Participants are blinded throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jun.-Prof. Dr. med. Simon Becker, M.D.

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 27, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning immediately after publication of the respective main study and explorative ancillary studies with no end date.
• Access Criteria: IPD can be accessed by peers and other investigators upon personal request to the principal investigator with a reasonable proposal including a detailed description of the planned analyses. The Trial Management Committee will critically review this proposal together with the principal investigator.

Locations

DE (1)