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 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. It could not only improve respiratory values, but also decrease the incidence of postoperative pulmonary complications, which is a major cause of death after thoracic surgery.

Thus, individualized FCV, based on compliance guided pressure settings, will be compared to best clinical practice pressure-controlled ventilation in thoracic surgery requiring one lung ventilation in a randomized controlled trial. Based on a previous preclinical trial improved oxygenation will be expected and thus arterial partial pressure of oxygen (pO2) 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.

• 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
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female subjects ≥ 18 years
• Body weight ≥ 40 kg
• Size of double lumen tube ≥ 37 CH
• 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. Individualisation will be established by compliance guided end-expiratory and peak pressure setting during double lung ventilation as well as one lung ventilation, flow setting will be adjusted to secure normocapnia and I:E Ratio set to 1:1.	Device: Evone; Airway ventilation device
Active Comparator: PCV; Artificial ventilation will be performed with low tidal volume pressure-controlled ventilation (Primus, Dräger, Lübeck, Germany) during thoracic surgery. Peak pressure will be set to achieve a tidal volume of 7ml/kg predicted body weight at a compliance titrated positive end-expiratory pressure in double lung ventilation and 6ml/kg PBW in one lung ventilation. Respiratory rate will be set to maintain normocapnia and I:E ratio set to 1:1.5 except extension of expiration is necessary in order to avoid air trapping.	Device: Primus; Airway ventilation device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Horowitz Index	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
pulmonary shunt fraction	calculation of pulmonary shunt fraction via arterial and central venous blood gas analysis	after 30 minutes of one lung ventilation

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

• 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): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• 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