Flow-Controlled Ventilation to Improve Postoperative Pulmonary Outcome After Thoracic Surgery

NCT07623395 | Not Yet Recruiting

• 1 other identifier: CTU S26.006
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

In an international multicenter randomized clinical pilot trial, intraoperative flow-controlled ventilation (FCV) will be compared with volume-controlled ventilation (VCV) in patients scheduled for (open, video- or robot-assisted) thoracic surgery with one-lung ventilation (OLV). This pilot trial is designed to test the feasibility and safety of FCV during all phases of intraoperative ventilation, and in particular during OLV, and to inform the design of a future trial testing the efficacy of FCV with regard to postoperative outcomes, including postoperative pulmonary complications (PPC). The ventilation modes are conducted with CE-marked medical devices (anesthesia ventilators or medical ventilators), however these medical devices themselves are not under investigation. All CE-marked standard medical devices from varied manufacturers in use at the participating study centers will be used in full accordance with their instructions for use. FCV has shown safety and feasibility in various surgical settings, including thoracic surgery with OLV, however its feasibility in a multicenter trial has not been investigated yet.

Conditions

Mechanical Ventilation; Postoperative Pulmonary Complications (PPCs)

Keywords

Flow-Controlled Ventilation; Thoracic Surgery; One-Lung Ventilation; Mechanical Power

Outcome Measures

Primary Outcomes (1)

• Feasibility (Proportion of Full Adherence to the Ventilation Protocols)

  Outcomes in this pilot study are selected to support the evaluation of feasibility of the ventilation protocols used and study protocol integrity. The primary outcome of this pilot study is a composite of feasibility issues of the ventilation protocols, including * correct use of predefined standard ventilator settings; * correct titration of PEEP and driving pressure (with FCV), and correct PEEP and tidal volume (with VCV); * correct titration of FiO2; * correct respiratory monitoring; * any significant deviation from the predefined standard ventilator settings, beyond pre-approved deviations for safety; and * any significant deviation in ventilator settings based on surgeon's assessment of surgical conditions. At least 80% of patients must receive ventilation according to the study protocol to progress to the future trial.

  From enrollment to the end of intraoperative surgical procedures at the day of surgery.

Secondary Outcomes (2)

• Safety (Proportion of unacceptable ventilation parameters and incidence of intraoperative pulmonary complications)

  From enrollment to the end intraoperative surgical procedures on the day of surgery.

• Protocol Feasibility (Proportion of full adherence to the study protocol)

  From enrollment to the seventh postoperative day or until discharge from the hospital.

Other Outcomes (1)

• Incidence of Postoperative Pulmonary Complications

  From enrollment to the seventh postoperative day or until discharge from the hospital

Study Arms (2)

Flow-Controlled Ventilation

EXPERIMENTAL

The intervention to be investigated is an intraoperative ventilation strategy with individualized FCV with dynamic compliance guided titration of PEEP and driving pressure during all phases of intraoperative ventilation, and in particular OLV, aiming at maximum recruitment of lung tissue without causing overdistention.

Procedure: Flow-Controlled Ventilation

Volume-Controlled Ventilation

ACTIVE COMPARATOR

intraoperative ventilation strategy with current best practice lung protective VCV with standard PEEP

Procedure: Volume-Controlled Ventilation

Interventions

Flow-Controlled Ventilation PROCEDURE

In the FCV group, patients will be ventilated using the EVONE ventilator with dynamic compliance-guided titration of PEEP and driving pressure. Ventilation starts with a PEEP of 5 cmH2O and a Ppeak of 15 cmH2O. Both parameters are increased stepwise to identify the PEEP associated with the highest tidal volume and best dynamic compliance, followed by further adjustment of Ppeak to determine the optimal driving pressure. No recruitment maneuvers are routinely performed. Ventilation is provided with an I:E ratio of 1:1, while flow is adjusted to maintain normocapnia (target etCO2 4.5-5.8 kPa). FiO2 is titrated to maintain SpO2 \>92%. Rescue crossover to conventional VCV is permitted in cases of ventilator malfunction or unresolved impairment of oxygenation, ventilation, or CO2 elimination, at the discretion of the attending anesthesiologist.

Flow-Controlled Ventilation

Volume-Controlled Ventilation PROCEDURE

In the VCV group, intraoperative ventilation will be provided using standard anesthesia ventilators routinely used at the participating centers. Patients will receive lung-protective VCV with tidal volumes of 7-9 ml/kg predicted body weight during two-lung ventilation and 5-6 ml/kg during one-lung ventilation. Respiratory rate and FiO2 will be adjusted to maintain normocapnia (target etCO2 4.5-5.8 kPa) and SpO2 \>92%, with an inspiratory-to-expiratory ratio of 1:1 to 1:2. Ventilation will start with a PEEP of 5 cmH2O, while further adjustments of ventilatory parameters, including PEEP, are left to the discretion of the attending anesthesiologist according to routine clinical practice. Rescue crossover to FCV is not permitted; however, switching to another conventional ventilation mode is allowed in cases of ventilator malfunction or unresolved impairment of oxygenation, ventilation, or CO2 elimination.

Volume-Controlled Ventilation

Eligibility Criteria

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

You may qualify if:

• aged ≥ 18 years; and
• scheduled for elective open, video- or robot-assisted thoracic surgery with one-lung ventilation using a double-lumen tube (DLT); and
• able to give written informed consent.

You may not qualify if:

• body weight \< 40 kg;
• ASA score IV - VI;
• lung separation with other method than DLT (e.g. difficult airway, tracheostomy);
• previous lung surgery;
• COPD GOLD grades III and IV, lung fibrosis, documented bullae, severe emphysema, pneumothorax;
• uncontrolled asthma;
• Heart failure NYHA Grade 3 and 4, Coronary Heart Disease CCS Grade 3 and 4;
• documented pulmonary arterial hypertension \>25 mmHg mPAP at rest or \>40mmHg syst. (estimated by ultrasound) or \>20 mmHg mPAP measured by right heart catheterization, or pulmonary vascular resistance \> 2.0 Wood units;
• documented or suspected neuromuscular disease (thymoma, myasthenia, myopathies, muscular dystrophies, others);
• planned mechanical ventilation after surgery;
• bilateral procedures;
• surgery in prone position;
• persistent hemodynamic instability, intractable shock;
• intracranial injury or tumor;
• esophagectomy, pleural surgery only, sympathectomy surgery only, chest wall surgery only, mediastinal surgery only, lung transplantation;

Sponsors & Collaborators

• Cantonal Hospital of St. Gallen: lead

Study Sites (1)

Department of Anaesthesiology, HOCH Health Ostschweiz, Cantonal Hospital St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

Related Publications (3)

• Hanselmann J, Wagner F, Schultz MJ, Yurttas T. Flow Controlled as Compared to Pressure-Controlled Ventilation for One-Lung Ventilation During Thoracic Surgery. A A Pract. 2026 Apr 14;20(4):e02185. doi: 10.1213/XAA.0000000000002185. eCollection 2026 Apr 1.

  PMID: 41980035 BACKGROUND

• Abram J, Spraider P, Martini J, Velik-Salchner C, Dejaco H, Augustin F, Putzer G, Hell T, Barnes T, Enk D. Flow-controlled versus pressure-controlled ventilation in thoracic surgery with one-lung ventilation - A randomized controlled trial. J Clin Anesth. 2025 Apr;103:111785. doi: 10.1016/j.jclinane.2025.111785. Epub 2025 Feb 27.

  PMID: 40020438 BACKGROUND

• Wittenstein J, Scharffenberg M, Ran X, Keller D, Michler P, Tauer S, Theilen R, Kiss T, Bluth T, Koch T, Gama de Abreu M, Huhle R. Comparative effects of flow vs. volume-controlled one-lung ventilation on gas exchange and respiratory system mechanics in pigs. Intensive Care Med Exp. 2020 Dec 18;8(Suppl 1):24. doi: 10.1186/s40635-020-00308-0.

  PMID: 33336305 BACKGROUND

Related Links

• website of the PROFLOW Series
• Website of the Protective Ventilation Network

Study Officials

• Timur Yurttas, MD

  Department of Anaesthesiology, HOCH Health Ostschweiz, Cantonal Hospital St. Gallen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timur Yurttas, MD

CONTACT

0041714949158; info@proflow-series.org

Sara Wijnant, MD, PhD

CONTACT

0041714941501; sara.wijnant@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Study participants are blinded to their group-specific intervention assignment after randomization, meaning that all patients will remain unaware of their allocation until the conclusion of the pilot study. The treating physicians and the staff responsible for intra- and postoperative patient care cannot be blinded due to the use of different ventilation devices during the interventions. The same study personnel also conduct the postoperative follow-up assessments. Therefore, the study is conducted in a single blinded design.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Senior Physician, MD, Department of Anaestheisology

Model Details: International multicenter randomized clinical pilot trial

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)