Flow Controlled Ventilation in Thoracic Surgery

Positive-Pressure Respiration, Intrinsic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04534933
• Other study ID #: 1014/2020
• Status: Completed
• Phase: N/A
• Start date: October 29, 2020
• Est. completion date: February 16, 2022

Study information

• Verified date: February 2020
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 16, 2022
• Est. primary completion date: February 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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%)

Related Conditions & MeSH terms

• Positive-Pressure Respiration, Intrinsic

Intervention

Device:
• Evone
Airway ventilation device
• Primus
Airway ventilation device

Locations

Country	Name	City	State
Austria	Medical University Innsbruck	Innsbruck	Tyrol

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Horowitz Index	arterial partial pressure of oxygen (paO2) / fraction of inspired oxygen (FiO2)	after 30 minutes of one lung ventilation
Secondary	pulmonary shunt fraction	calculation of pulmonary shunt fraction via arterial and central venous blood gas analysis	after 30 minutes of one lung ventilation