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Clinical Trials/NCT04534933
NCT04534933
Completed
Not Applicable

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

Medical University Innsbruck1 site in 1 country46 target enrollmentOctober 29, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Positive-Pressure Respiration, Intrinsic
Sponsor
Medical University Innsbruck
Enrollment
46
Locations
1
Primary Endpoint
paO2 / FiO2 ratio (Horowitz Index)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 29, 2020
End Date
February 16, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Medical University Innsbruck
Responsible Party
Sponsor

Eligibility Criteria

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%)

Outcomes

Primary Outcomes

paO2 / FiO2 ratio (Horowitz Index)

Time Frame: after 30 minutes of one lung ventilation

Comparison of oxygenation assessed by arterial partial pressure of oxygen (paO2) / fraction of inspired oxygen (FiO2)

Secondary Outcomes

  • 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))
  • 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))
  • 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))
  • 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))
  • 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))
  • 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))
  • 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))
  • 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))
  • length of PACU stay(Time from PACU admission to transfer to a general ward in hours)
  • 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))
  • Concentration of plamatic cytokine levels(preoperative before induction of general anesthesia and postoperative at PACU admission and 1 hour thereafter)
  • length of hospital stay(days from surgery to hospital discharge)
  • postoperative pulmonary complications (PPC)(until hospital discharge or day 30 of hospital stay)
  • 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))
  • 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))

Study Sites (1)

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