Effects of Oxygen Supply on Hypoxic Pulmonary Vasoconstriction and Lung Collapse After Lung Isolation in Thoracic Surgery - a Prospective, Randomized Clinical Trial

1051/2023

The goal of this randomized clinical trial is to compare a liberal versus restrictive oxygen supply (fraction of inspired oxygen, FiO2) strategy in patients scheduled for thoracic surgery requiring one-lung ventilation during lung isolation. The primary and secondary outcome parameters are: * oxygenation of the blood after 30 minutes of one-lung ventilation, assessed by PaO2/FiO2 ratio * time to lung collapse after start of one-lung ventilation Participants in the control goup will receive an oxygen content of 100% before lung isolation, which will be subsequently decreased to achieve normoxia or mild hyperoxia (PaO2 of 75-120 mmHg). The intervention group will receive the previous, during two-lung ventilation set, oxygen content and after lung isolation oxygen supply will be increased to secure adequate oxygenation of the blood (PaO2 75-120 mmHg) during one-lung ventilation. The investigators hypothesize, that a higher fraction of inspired oxygen may impede hypoxic pulmonary vasoconstriction of the collapsed lung and thus decrease overall oxygenation performance during one-lung ventilation. Secondary endpoint will be the time to lung collapse, as a lower fraction of inspired oxygen and thus a higher nitrogen content may impede lung collapse.

2023-07-19

2024-03-07

2024-03-07

Completed

55

Inclusion Criteria: * Male and female subjects ≥ 18 years * Elective thoracic surgery requiring OLV * American Society of Anesthesiologists physical status classification I-III * Written informed consent Exclusion Criteria: * Emergency surgery * Female subjects known to be pregnant * Known participation in another interventional clinical trial * Empyema evacuation or signs of pulmonary infection

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'non-blinded, randomized, controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Study participants will be randomized after induction of general anesthesia and thus are not aware of the treatment arm, which solely differs at the time of lung isolation.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 55, 'type': 'ACTUAL'}}

2024-03-12