Flow Controlled Ventilation in Thoracic Surgery

Not Applicable

Completed

• Conditions: Positive-Pressure Respiration, Intrinsic
• Interventions: Device: Evone; Device: Primus

• Registration Number: NCT04534933
• Lead Sponsor: Medical University Innsbruck

Brief Summary

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.

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 Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-31
• Study First Posted: 2020-09-01
• Study Start: 2020-10-29
• Primary Completion: 2022-02-16
• Study Completion: 2022-02-16
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FCV	Evone	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.
PCV	Primus	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)	Comparison of applied tidal volume
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)	Comparison of measured respiratory compliance
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)	Comparison of set positive end-expiratory pressure
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)	Comparison of set peak pressure
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)	Comparison of resulting driving pressure
applied mechanical power	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)	Comparison of calculated applied mechanical power from the ventilator
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)	Comparison of measured respiratory resistance
postoperative pulmonary complications (PPC)	until hospital discharge or day 30 of hospital stay	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.
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)	Comparison of measured mean arterial pressure
length of PACU stay	Time from PACU admission to transfer to a general ward in hours	Duration of the patient at the post-anesthesia care unit (PACU)
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)	Comparison of measured central venous pressure
Concentration of plamatic cytokine levels	preoperative before induction of general anesthesia and postoperative at PACU admission and 1 hour thereafter	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).
length of hospital stay	days from surgery to hospital discharge	Comparison of length of hospital stay after thoracic surgery
decarboxylation (paCO2)	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)	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
venous admixture (Qs / Qt)	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)	Comparison of calculated venous admixure from arterial and central venous blood gas analysis
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)	Comparison of respiratory minute volume
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)	Comparison of respiratory rate
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)	Comparison of measured heart rate

Trial Locations

Locations (1)

Medical University Innsbruck; 🇦🇹 Innsbruck, Tyrol, Austria