Medical University Innsbruck
Innsbruck, Tyrol, 6020, Austria
NCT Number: NCT04534933
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.
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Notify Me18 year–99 year
All sexes
Interventional
Not applicable
Innsbruck, Tyrol, 6020, Austria
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Airway ventilation device
Airway ventilation device
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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: Time from PACU admission to transfer to a general ward in hours
Duration of the patient at the post-anesthesia care unit (PACU)
Time frame: days from surgery to hospital discharge
Comparison of length of hospital stay after thoracic surgery
Time frame: 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.
Medical University Innsbruck
Other
Flow Controlled Ventilation Versus Pressure Controlled Ventilation in Thoracic Surgery With One Lung Ventilation - a Prospective, Randomized Clinical Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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