Flow Controlled Ventilation in Thoracic Surgery

NCT04534933 | Completed

• 1 other identifier: 1014/2020
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Positive-Pressure Respiration, Intrinsic

Keywords

flow controlled ventilation; pressure controlled ventilation; thoracic surgery; one lung ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• 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)

• 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)

• 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

  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

  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)

Study Arms (2)

FCV

EXPERIMENTAL

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

PCV

ACTIVE COMPARATOR

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

Interventions

Evone DEVICE

Airway ventilation device

FCV

Primus DEVICE

Airway ventilation device

PCV

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Related Publications (4)

• 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.

  PMID: 25058504 BACKGROUND

• 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.

  PMID: 29734208 BACKGROUND

• 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.

  PMID: 31828755 BACKGROUND

• 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.

  PMID: 31992213 BACKGROUND

MeSH Terms

Conditions

Positive-Pressure Respiration, Intrinsic

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Judith Martini, MD

  Medical University Innsbruck, Dept. of Anaesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: controlled, prospective

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: September 1, 2020
• Study Start: October 29, 2020
• Primary Completion: February 16, 2022
• Study Completion: February 16, 2022
• Last Updated: December 16, 2024

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)