Flow Controlled Ventilation in Thoracic Surgery

• Sponsor: Medical University Innsbruck (Other)
• Overall Status: Completed
• CT.gov ID: NCT04534933
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 2
• Actual Duration (Months): 15.6
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Positive-Pressure Respiration, Intrinsic	Device: Evone; Device: Primus	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: controlled, prospectivecontrolled, prospective
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Flow Controlled Ventilation Versus Pressure Controlled Ventilation in Thoracic Surgery With One Lung Ventilation - a Prospective, Randomized Clinical Study
• Actual Study Start Date: Oct 29, 2020
• Actual Primary Completion Date: Feb 16, 2022
• Actual Study Completion Date: Feb 16, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Horowitz Index [after 30 minutes of one lung ventilation]

   arterial partial pressure of oxygen (paO2) / fraction of inspired oxygen (FiO2)

Secondary Outcome Measures

1. pulmonary shunt fraction [after 30 minutes of one lung ventilation]

   calculation of pulmonary shunt fraction via arterial and central venous blood gas analysis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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%)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University Innsbruck	Innsbruck	Tyrol	Austria	6020

Sponsors and Collaborators

• Medical University Innsbruck

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Medical University Innsbruck
• ClinicalTrials.gov Identifier: NCT04534933
• Other Study ID Numbers: 1014/2020
• First Posted: Sep 1, 2020
• Last Update Posted: Feb 17, 2022
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Medical University Innsbruck: flow controlled ventilation; pressure controlled ventilation; thoracic surgery; one lung ventilation
• Additional relevant MeSH terms: Positive-Pressure Respiration, Intrinsic

Study Results

No Results Posted as of Feb 17, 2022