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BIPAP- versus flow-controlled ventilation in burn patients: A monocentric, randomised controlled trial

BIPAP- versus flow-controlled ventilation in burn patients: A monocentric, randomised controlled trial - BIFLOWBURN

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00033223
Enrollment
24
Registered
2023-12-22
Start date
2024-01-02
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn patients in need of ventilation

Interventions

Group 1: Flow-controlled ventilation (FCV) with an individualised positive end-expiratory pressure and an individualised driving pressure, resulting in a liberal tidal volume Group 2: Controlled Bipha

Sponsors

Klinik für Anästhesiologie, Intensiv- und Schmerzmedizin; BG Universitätsklinikum Bergmannsheil Bochum gGmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: - in already ventilated patients: invasive ventilation for = 24 hours before admission to the Burn Centre - in not ventilated patients: indication for tracheal intubation and controlled ventilation within 48 hours of admission to the Burn Centre - estimated (further) duration of ventilation = 24 hours - start of intervention = 48 hours after admission to the Burn Centre - a central venous catheter and an arterial line for the intensive care treatment - signed informed consent by the patient or a legal presentative, by a representative of the patients will in incompetent patients or by a study-independent physician in charge in incompetent patients without a respresentative of the patients will

Exclusion criteria

Exclusion criteria: - participation in another interventional trial - invasive ventilation for > 24 hours before admission to the Burn Centre - start of the intervention > 48 hours after admission to the Burn Centre - estimated (further) duration of ventilation < 24 hours - no informed consent by the patient, by a legal representative, by a representative of the patients will in incompetent patients or by a study-independent physician in charge in incompetent patients without a respresentative of the patients will

Design outcomes

Primary

MeasureTime frame
Computed mechanical power in joules per minute (J/min) during up to 70 hours of controlled ventilation

Secondary

MeasureTime frame
Main study: - oxygenation indices during controlled ventilation - arterial partial pressures of carbon dioxide (PaCO2) during controlled ventilation - ventilation parameters during controlled ventilation - incidences of pulmonary complications up to 10 days after starting the intervention - incidences of extra-pulmonary complications up to 10 days after starting the intervention - duration of ventilation - intensive care unit and total inpatient length of stay - different intensive care scores (including APACHE and SAPS) up to 10 days after starting the intervention - mortality 30 days, 90 days and half a year after starting the intervention Ancillary studies: - parameters of indirect calorimetry during controlled ventilation - parameters of advanced haemodynamic monitoring (including PiCCO-Technology and Acumen IQ Sensor) - characterization of the (acute) lung and burn inhalational injury regarding pulmonary and systemic biomarkers

Countries

Germany

Contacts

Public ContactSimon Becker

Klinik für Anästhesiologie, Intensiv- und Schmerzmedizin; BG Universitätsklinikum Bergmannsheil Bochum gGmbH

simon.becker@bergmannsheil.de+49 234 302 6917

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026