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

ConditionsMechanical Ventilation Postoperative Pulmonary Complications (PPCs)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorCantonal Hospital of St. Gallen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

body weight < 40 kg;

ASA score IV - VI;

lung separation with other method than DLT (e.g. difficult airway, tracheostomy);

previous lung surgery;

Trial design

Design model

Parallel

Treatments tested in this trial

Flow-Controlled Ventilation
Procedure/Surgery
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.
Volume-Controlled Ventilation
Procedure/Surgery
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.

Treatment groups

140 Participants

are divided into 2 treatment groups

Group A: Flow-Controlled VentilationExperimental treatment 1 intervention

Group B: Volume-Controlled VentilationActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Secondary outcomes

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

Secondary outcomes of this pilot focus are related to safety of the ventilation protocols and feasibility of the study protocol. For safety this is a composite of: * unacceptable intraoperative measures of gas exchange; * unacceptable low minute ventilation; * unacceptable ventilator parameters; * intraoperative pulmonary complications, such as severe atelectases and pneumothorax; and * intraoperative hemodynamic complications, such as unexpected hypotension or need for high dosages of vasopressors, arrhythmias that need an intervention. Safety targets include SpO2 \>92%, EtCO2 4.5-5.8 kPa, and MAP \>65 mmHg. Rescue ventilation or crossover is permitted for persistent gas exchange abnormalities, haemodynamic instability, or ventilator malfunction despite corrective measures. Minute ventilation and vasopressor requirements are recorded without prespecified numerical thresholds.

Time frame

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

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

For study protocol feasibility this is a composite of: * proper handling of the regulatory aspects of the study, including correct enrollment of patients and correct randomization; * adherence to the study protocol, including, relevant ventilation strategy-related aspects; and relevant aspects not related to ventilation; and * correct and complete collection of intraoperative and postoperative variables and outcomes.

Time frame

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

Other outcomes

Incidence and severity of postoperative pulmonary complications

To test the effect of Flow-Controlled Ventilation on the incidence and severity of Postoperative Pulmonary Complications (PPC). PPC followed the 'PRECISION' Delphi framework and is a composite of: * Dyspnea * Bronchospasm (wheeze) * Upper airway obstruction * Tracheobronchitis * Atelectasis * Pleural effusion * Pulmonary congestion * Suspected respiratory infection * Pneumonia * Aspiration Pneumonitis * Hypoxemic Respiratory failure (mild/moderate/severe) * Hypercapnic respiratory failure * ARDS * Empyema * Hemothorax * Pneumothorax * Pulmonary embolism * Bronchopleural fistula * Reintubation * Bronchoscopy * Surgical re-intervention

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cantonal Hospital of St. Gallen

Lead sponsor

Source ClinicalTrials.gov

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