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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 low tidal volume 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 tidal volume with recruitment maneuvers during thoracic surgery in adults.
We hypothesize that in adult, non-obese patients undergoing thoracic surgery under standardized OLV with variable tidal volumes, modearte PEEP and recruitment maneuvers as compared to constant without recruitment maneuvers prevent PPCs.
Patients will be randomly assigned to one of two groups:
FIX TIDAL VOLUME GROUP (Groupfix): mechanical ventilation with constant (6 ml/kgIBW) tidal volume and PEEP of 5 cmH2O with recruitment maneuvers
VARIABLE TIDAL VOLUME GROUP (Groupvar): mechanical ventilation with variable (6 ml/kgIBW ± 33%) tidal volume with variable respiratory rate to maintain constant minute ventilation and PEEP of 5 cmH2O with recruitment maneuvers.
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 will be 6 ml/kg predicted body weight ±33% with 5 cmH2O PEEP. Respiratory rate will be adjusted to maintain same minute ventilation as during two-lung ventilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GruopFix | No Intervention | one-lung ventilation with constant tidal volume | |
| GroupVariable | Active Comparator | one-lung ventilation with variable tidal volume Intervention: change of ventilatory settings |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| change of ventilatory settings | Other | change of tidal volume during one-lung ventilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| intraoperative oxygenation | PaO2 < 60 mmHg | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pulmonary complications | infiltrate on chest X-ray, fever, laboratory and physical signs of infection | 90 days |
| postoperative extra-pulmonary complications | new atrial fibrillation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Debrecen, Department of Anesthesiology and Intensive Care | Debrecen | 4032 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38581926 | Derived | Szamos K, Balla B, Paloczi B, Enyedi A, Sessler DI, Fulesdi B, Vegh T. One-lung ventilation with fixed and variable tidal volumes on oxygenation and pulmonary outcomes: A randomized trial. J Clin Anesth. 2024 Aug;95:111465. doi: 10.1016/j.jclinane.2024.111465. Epub 2024 Apr 6. |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D012128 | Respiratory Distress Syndrome |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |
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| 90 days |
| 30-day survival/mortality | number of death within 30 days after surgery | 30 days |
| 90-day survival/mortality | number of death death within 90 days after surgery | 90 days |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |