Flow Controlled Ventilation in Thoracic Surgery

Flow Controlled Ventilation Versus Pressure Controlled Ventilation in Thoracic Surgery With One Lung Ventilation - a Prospective, Randomized Clinical Study

This trial investigates effects of individualized (by compliance guided pressure settings) flow-controlled ventilation compared to best clinical practice pressure-controlled ventilation in thoracic surgery requiring one lung ventilation.

Study Overview

• Status: Completed
• Conditions: Positive-Pressure Respiration, Intrinsic
• Intervention / Treatment: Device: Evone; Device: Primus

Detailed Description

Flow-controlled ventilation (FCV) is a novel ventilation method with promising first results in porcine studies as well as clinical cross-over trials. A more efficient and maybe lung protective ventilation strategy would be crucial in the challenging situation of one lung ventilation during thoracic surgery, when the whole gas exchange has to be provided by just one half of the lungs.

Thus, individualized FCV, based on compliance guided pressure settings, will be compared to standard of pressure-controlled ventilation in thoracic surgery requiring one lung ventilation in a randomized controlled trial. Based on previous preclinical trials an improvement of oxygenation by 15% will be expected and in order to transfer the preclinical results to humans oxygenation assessed by paO2 / FiO2 ratio after 30 minutes of one lung ventilation is the main primary outcome parameter of this study. Furthermore, improved recruitment of lung tissue due to controlled expiratory flow in FCV will be anticipated without the need of recruitment maneuvers, which may cause deleterious effects on lung tissue. Accordingly any recruitment maneuvers will be omitted in the FCV group.

The investigators hypothesize that improved gas exchange in terms of improved oxygenation and reduced respiratory minute volume required for CO2-removal will be achieved with FCV compared to PCV. Secondary outcome parameters such as the incidence of postoperative pulmonary complications will be additionally assessed in order to plan future studies with clinically relevant outcome.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Medical University Innsbruck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male and female subjects ≥ 18 years
• Body weight ≥ 40 kg
• Elective thoracic surgery requiring OLV
• ASA I-III
• Written informed consent

Exclusion Criteria:

• Emergency surgery
• Female subjects known to be pregnant
• Known participation in another interventional clinical trial
• high pulmonary risk (ppo FEV1<20ml/kg in male or ppo FEV1<18ml/kg in female)
• Empyema evacuation or signs of pulmonary infection
• High grade CMP (EF<30%)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FCV; Artificial ventilation will be performed with individualized flow-controlled ventilation (Evone, Ventinova Medical B.V., Eindhoven, the Netherlands) during thoracic surgery. Individualization will be established by compliance guided end-expiratory and peak pressure setting during two lung ventilation as well as one lung ventilation, flow setting will be adjusted to secure normocapnia during two lung ventilation and the targeted paCO2 during one lung ventilation is 40-60 mmHg, provided that pH >7.2. The I:E ratio will be set to 1:1. The FiO2 will be set to achieve normoxia during two lung ventilation, increased to 100% before lung isolation and after 15 minutes of one-lung ventilation again decreased to secure normoxia or mild hyperoxia (target paO2 of 75-120 mmHg). No recruitment maneuver will be performed for re-inflation of the separated lung and after regain of spontaneous breathing tracheal extubation performed in the operating room.	Device: Evone; Airway ventilation device
Active Comparator: PCV; Artificial ventilation will be performed with pressure-controlled ventilation (Primus, Dräger, Lübeck, Germany) during thoracic surgery. Peak pressure will be set to achieve a tidal volume of 6-8 ml/kg predicted body weight (PBW) at a compliance titrated positive end-expiratory pressure during two lung ventilation and the tidal volume will be reduced to 4-6 ml/kg PBW during one lung ventilation. Respiratory rate will be set to maintain normocapnia during two lung ventilation and a targeted paCO2 level during one lung ventilation of 40-60 mmHg, provided that pH > 7.2. The I:E ratio will be set to 1:1.5 except extension of expiration is necessary in order to avoid air trapping. The FiO2 will be set to achieve normoxia during two lung ventilation, increased to 100% before lung isolation until 15 minutes of one lung ventilation and decreased thereafter to achieve a targeted paO2 level of 75-120 mmHg. For re-inflation a manual recruitment maneuver will be performed under surgical guidance.	Device: Primus; Airway ventilation device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
paO2 / FiO2 ratio (Horowitz Index)	Comparison of oxygenation assessed by arterial partial pressure of oxygen (paO2) / fraction of inspired oxygen (FiO2)	after 30 minutes of one lung ventilation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
decarboxylation (paCO2)	Required respiratory minute volume to achieve a taregeted paCO2 of 35-45 mmHg during two lung ventilation and 40-60 mmHg during one lung ventilation	during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
venous admixture (Qs / Qt)	Comparison of calculated venous admixure from arterial and central venous blood gas analysis	during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
respiratory minute volume	Comparison of respiratory minute volume	during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
respiratory rate	Comparison of respiratory rate	during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
tidal volume	Comparison of applied tidal volume	during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
positive end-expiratory pressure	Comparison of set positive end-expiratory pressure	during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
peak pressure	Comparison of set peak pressure	during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
driving pressure	Comparison of resulting driving pressure	during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
respiratory compliance	Comparison of measured respiratory compliance	during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
applied mechanical power	Comparison of calculated applied mechanical power from the ventilator	during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
respiratory resistance	Comparison of measured respiratory resistance	during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
heart rate	Comparison of measured heart rate	during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
mean arterial pressure	Comparison of measured mean arterial pressure	during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
central venous pressure	Comparison of measured central venous pressure	during two lung ventilation in supine position after anesthesia induction (T1) and change to lateral position (T2), after 15 (T3), 30 (T4) and 60 minutes (T5) of one lung ventilation and after reinflation before tracheal extubation (T6)
Concentration of plamatic cytokine levels	Plasmatic cytokine level of IL-6, IL-8, IL-10 and TNF-alpha will be assessed pre- (before induction of general anesthesia) and postoperative (ad PACU admission and 60 minutes therafter).	preoperative before induction of general anesthesia and postoperative at PACU admission and 1 hour thereafter
length of PACU stay	Duration of the patient at the post-anesthesia care unit (PACU)	Time from PACU admission to transfer to a general ward in hours
length of hospital stay	Comparison of length of hospital stay after thoracic surgery	days from surgery to hospital discharge
postoperative pulmonary complications (PPC)	PPC will be assessd daily until hospital discharge or day 30 of hospital stay from the medical records during the follow-up period. The European Perioperative Clinical Outcome (EPCO) definition will be used to assess the occurrence of PPC.	until hospital discharge or day 30 of hospital stay

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Investigators: Principal Investigator: Judith Martini, MD, Medical University Innsbruck, Dept. of Anaesthesiology

Publications and helpful links

General Publications

• Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.
• Schmidt J, Wenzel C, Mahn M, Spassov S, Cristina Schmitz H, Borgmann S, Lin Z, Haberstroh J, Meckel S, Eiden S, Wirth S, Buerkle H, Schumann S. Improved lung recruitment and oxygenation during mandatory ventilation with a new expiratory ventilation assistance device: A controlled interventional trial in healthy pigs. Eur J Anaesthesiol. 2018 Oct;35(10):736-744. doi: 10.1097/EJA.0000000000000819.
• Weber J, Schmidt J, Straka L, Wirth S, Schumann S. Flow-controlled ventilation improves gas exchange in lung-healthy patients- a randomized interventional cross-over study. Acta Anaesthesiol Scand. 2020 Apr;64(4):481-488. doi: 10.1111/aas.13526. Epub 2019 Dec 30.
• Weber J, Straka L, Borgmann S, Schmidt J, Wirth S, Schumann S. Flow-controlled ventilation (FCV) improves regional ventilation in obese patients - a randomized controlled crossover trial. BMC Anesthesiol. 2020 Jan 28;20(1):24. doi: 10.1186/s12871-020-0944-y.

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2020
• Primary Completion (Actual): February 16, 2022
• Study Completion (Actual): February 16, 2022

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (Actual): September 1, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: thoracic surgery; one lung ventilation; pressure controlled ventilation; flow controlled ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Positive-Pressure Respiration, Intrinsic
• Other Study ID Numbers: 1014/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No