PROtective Ventilation With FLOW-Controlled Ventilation

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

February 2, 2025

Primary Completion Date

December 30, 2025

Study Completion Date

December 31, 2025

Conditions
Postoperative Pulmonary Complications (PPCs)Feasibility StudiesPilot Study
Interventions
OTHER

Intraoperative flow-controlled ventilation strategy

"In the FCV group, intraoperative ventilation will be provided with the EVONE (IES Ventinova Medical).PEEP and Ppeak are titrated guided by dynamic compliance, as follows: Starting from a default setting of 5 cmH2O of PEEP and 15 cmH2O of Ppeak, PEEP and Ppeak are equally increased by 1 cmH2O steps and the PEEP value with the highest VT and thus highest dynamic compliance is defined as best PEEP. Subsequently, Ppeak is stepwise (+1 cmH2O) increased until there is no further over-proportional increase in tidal volume (VT) (i.e. measured VT \> expected VT according to measured dynamic compliance), defined as best driving pressure. No recruitment maneuvers are carried out during FCV. With the I:E ratio set to 1:1, flow is adjusted to establish normocapnia (target etCO2 4.5 to 5.8 kPa). FiO2 is adjusted to maintain oxygen saturation (SpO2) \> 92%."

OTHER

Intraoperative pressure-controlled ventilation strategy

In the PCV group, intraoperative ventilation will be provided by a standard anesthesia ventilator in use in the respective participating centers. Patients will be ventilated in PCV mode, at the lowest inspired oxygen fraction (FiO2), to maintain oxygen saturation (SpO2) \> 92%. It is left to the discretion of the attending anesthesiologist to use a higher fraction of FiO2. Inspiratory to expiratory ratio is set at 1:1 to 1:2, respiratory rate will be adjusted to target normocapnia (target etCO2 4.5 to 5.8 kPa. VT will be set at 7 to 9 ml/kg predicted body weight (PBW). The PBW is calculated according to a predefined formula: 50 + 0.91 x (centimeters of height - 152.4) for males and 45.5 + 0.91 x (centimeters of height - 152.4) for females. Ventilation starts with 5 cm H2O PEEP, and can be increased to 10 cm H2O PEEP.

Trial Locations (4)

1007

NOT_YET_RECRUITING

Department of Anesthesiology, Amsterdam UMC, Amsterdam

6000

NOT_YET_RECRUITING

Department of Anesthesiology, Cantonal Hospital Luzern, Lucerne

9000

RECRUITING

Department of Anaesthesiology, Rescue- and Pain Medicine Cantonal Hospital St. Gallen, Sankt Gallen

44789

RECRUITING

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

All Listed Sponsors
collaborator

University Hospital Bergmannsheil Bochum

OTHER

collaborator

Luzerner Kantonsspital

OTHER

collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

lead

Cantonal Hospital of St. Gallen

OTHER