Samsung medical center
Seoul, 06351, South Korea
NCT Number: NCT04260451
Pulmonary complications are the most common complication in thoracic surgery and the leading cause of mortality.Therefore, lung protection is utmost important, and protective ventilation is strongly recommended in thoracic surgery. Protective ventilation is a prevailing ventilatory strategy in these days and is comprised of small tidal volume, limited inspiratory pressure, and application of positive end-expiratory pressure. However, several retrospective studies recently suggested that tidal volume, inspiratory pressure, and positive end-expiratory pressure are not related to patient outcomes, or only related when they influenced the driving pressure. Recently, the investigators reported the first prospective study about the driving pressure-guided ventilation in thoracic surgery. PEEP was titrated to bring the lowest driving pressure in each patient and applied throughout the one lung ventilation. The application of individualized PEEP reduced the incidence of pulmonary complications.However, that study was small size single center study with 312 patients. Thus, investigators try to perform large scale multicenter study. Through this study investigators evaluate that driving pressure-guided ventilation can reduce the incidence of postoperative pulmonary complications compared with conventional protective ventilation in thoracic surgery.
Looking for future studies?
Notify Me19 year and older
All sexes
Interventional
Not applicable
Seoul, 06351, South Korea
Nowdays, the usual setting of protective ventilation during one lung ventilation is tidal volume (VT) 5 ml/kg of predicted body weight, positive end-expiratory pressure (PEEP) 5 cm H2O and plateau pressure (Pplat) less than 25 cmH2O.
However, a high incidence of postoperative pulmonary complications is still being observed even with a protective ventilatory strategy.
Driving pressure is [Pplat - PEEP] and is the pressure required for the alveolar opening. Static lung compliance (Cstat) is expressed as [VT / (Pplat - PEEP)]. Thus, driving pressure is also expressed as [VT / Cstat]. Driving pressure has an inverse relationship with Cstat and orthodromic relationship with VT according to this formula. High driving pressure indicates poor lung condition with decreased lung compliance.
Thus, investigator try to prove that driving pressure limited ventilation is superior in preventing postoperative pulmonary complications to existing protective ventilation in large scale multicenter study.
Recruit maneuver perform all group after intubation (stepwise increase of positive end expiratory pressure 5,10,15 cmH2O with tidal volume 5mL/kg).
The control arm receives existing conventional protective ventilation with tidal volume of 5mL/kg of ideal body weight and PEEP of 5 cmH2O during one-lung ventilation.
The driving pressure arm receives driving pressure limited ventilation with tidal volume of 5mL/kg of ideal body weight and individualized PEEP. Individualized PEEP is adjusted to minimize driving pressure, it find through decremental PEEP titration from 10 to 2 cmH2O during one-lung ventilation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Adults older than or equal to 19 years with American Society of Anesthesiologists physical status Ⅰ-Ⅲ Patient who undergoes one-lung ventilation (more than 60 minutes) for elective thoracic surgery
Exclusion criteria
Driving Pressure Limited Ventilation
Positive end expiratory pressure is adjusted to minimize driving pressure, plateau pressure minus end expiratory pressure from 10 to 2 cmH2O during one-lung ventilation.
Time frame: within the first 7 days after surgery
Postoperative pulmonary complications are defined as one or more of the following:
Time frame: 15 minutes after one-lung ventilation
Partial pressure of oxygen in arterial blood (PaO2, mmHg) or PaO2/Inspired oxygen fraction (PF ratio)
Time frame: during surgery
the need for rescue ventilation to treat hypoxia (Inspired oxygen fraction 1.0, two lung ventilation, recruitment, PEEP change, Tidal volume change, continuous positive pressure ventilation, change to pressure control mode)
Time frame: 15 minutes after one-lung ventilation
Lung compliance (mL/mmHg)
Time frame: within the first 1 days after surgery
C-reactive protein (mg/L) of laboratory exam
Time frame: within the first 3 days after surgery
red blood cell, fresh frozen plasma, platelet
Time frame: within the first 7 days after surgery
acute kidney injury(acute kidney injury network criteria): Stage I: Diuresis < 0.5 mg/kg (6 h) or increase in serum Cr > 0.3 mg/dl. Stage II: Diuresis < 0.5 mg/kg (12 h) or basal Cr x 2 mg/dL. Stage III: Diuresis < 0.3 mg/kg (24 h) or anuria (12 h) or basal Cr x 3 mg/dL, or Cr > 4 mg/dL or renal replacement therapy.
Time frame: within the first 7 days after surgery
diagnosed by Confusion Assessment method (CAM: positive or negative) or Medicines for treating delirium symptoms include antipsychotic drugs and benzodiazepines
Time frame: within the first 7 days after surgery
: The CDC defines a superficial incisional surgical site infection as one which meets the following criteria.
Time frame: within the first 7 days after surgery
Acute myocardial injury with clinical evidence of acute myocardial ischemia and with detection of a rise and/or fall of cardiac troponin values with at least one value above the 99th percentile upper reference limit and at least one of the following:
Time frame: within the first 7 days after surgery
Percutaneous coronary intervention or coronary artery surgery
Time frame: within the first 7 days after surgery
Magnetic resonance imaging diagnosis
Time frame: within the first 7 days after surgery
: A subset of sepsis (a life-threatening organ dysfunction resulting from dysregulated host responses to infection) in which underlying circulatory, cellular, and metabolic abnormalities are profound enough to substantially increase the risk of mortality. Despite adequate fluid resuscitation, patients have hypotension requiring vasopressors to maintain a mean arterial blood pressure above 65 mmHg and have an elevated serum lactate concentration of more than 2 mmol/L
Time frame: within the first 7 days after surgery
New arrhythmias that persist for more than 2 days
Time frame: within the first 30 days after surgery
the duration of hospital stay and intensive care unit stay (day)
Time frame: within the first 30 days after surgery
re-admission because of surgical related problems
Time frame: within the first 30 days after surgery
in hospital death or out of hospital
Samsung Medical Center
Other
Comparison of Postoperative Pulmonary Complications Between Driving Pressure Guided Ventilation and Conventional Protective Ventilation in Thoracic Surgery
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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.
Published trials that share one or more normalized conditions with this study.
NCT06457763
One-Lung Ventilation, Pathologic Processes
Istanbul, Maltepe, Turkey (Türkiye)
View Trial DetailsNCT06505772
One-Lung Ventilation, Thoracic Surgery
Damascus, Syria
View Trial DetailsNCT05946707
Lung Diseases, Mechanical Ventilation
Innsbruck, Tyrol, Austria
View Trial DetailsNCT04740151
Artificial Respiration, One-Lung Ventilation
Trieste, Italy
View Trial Details