ARDS, Human, Hypoxemia, Pneumonia, Pulmonary Sepsis
Conditions
Brief summary
During One-lung ventilation, the use of lower tidal volumes (VT) is helpful to avoid over-distension, provide sufficient oxygenation, but can result in increased atelectasis. Nevertheless, it is not known if, during one-lung ventilation with constant low VT, moderate levels of PEEP combined with lung recruitment maneuvers are superior to variable PEEP for intraoperative oxygenation and protection against PPCs. Aim of the study is to compare a strategy using constant tidal volume with recruitment maneuvers versus variable PEEP with recruitment maneuvers during thoracic surgery in adults. The investigators hypothesize that in adult, non-obese patients undergoing thoracic surgery under standardized OLV with variable PEEP and recruitment maneuvers as compared to constant PEEP without recruitment maneuvers prevent PPCs. Patients will be randomly assigned to one of two groups: FIX PEEP VOLUME GROUP (Groupfix): mechanical ventilation with constant (6 ml/kgIBW) tidal volume and PEEP of 5 cmH2O with recruitment maneuvers VARIABLE PEEP GROUP (Groupvar): mechanical ventilation with constant (6 ml/kgIBW) tidal volume with variable PEEP with recruitment maneuvers.
Detailed description
Lung separation will be performed by DLT technique. Mechanical ventilation will be applied in volume-controlled mode. During two-lung ventilation, VT will be set at 8 mL/kg predicted body weight. During one-lung ventilation, in GroupFix VT will be decreased to 6 mL/kg PBW with 5 cmH2O PEEP. In GroupVar VT mechanical ventilation with constant (6 ml/kgIBW) tidal volume with variable PEEP with recruitment maneuvers.
Interventions
Change of Positive End-Exspiratory Pressure during one-lung ventilation
Sponsors
University of Debrecen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient scheduled for open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring OLV (no emergency surgery) * BMI \< 35 kg/m2 * Age ≥ 18 years * Expected duration of surgery \> 60 min * Expected duration of anesthesia \> 90 min
Exclusion criteria
* COPD GOLD 3+4, lung fibrosis, documented bullae, severe emphysema, pneumothorax * uncontrolled asthma * NYHA 3+4, CCS 3+4 * previous thoracic surgery * ARDS (Berlin definition) * documented pulmonary arterial hypertension \> 40 mmHg syst * documented or suspected neuromuscular disease (thymoma, myasthenia) * planned mechanical ventilation after surgery * bilateral procedures * lung separation with other method than DLT (eg diff. airway, trachestomy) * surgery in prone position * persistent hemodynamic instability, intractable shock * intracranial injury or tumor * enrollment in other interventional study or refusal of informed consent * pregnancy (excluded by anamnesis and/or laboratory analysis)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative oxygenation | 1 day | PaO2 \< 60 mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pulmonary complications | 90 days | Infiltrate or atelectasis on chest X-ray, fever, laboratory and physical signs of infection |
| Postoperative extra-pulmonary complications | 90 days | new atrial fibrillation, tachycardia, heart failure, myocardial infarct |
| 30 day survival/mortality | 30 days | number of death within 30 days after surgery |
| 90 day survival/mortality | 90 days | number of death within 90 days after surgery |
| Postoperative oxygenation | 90 days | SpO2/FiO2 ratio |
Countries
Hungary
Outcome results
None listed