Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-26 @ 11:10 AM
NCT ID:
NCT01469728
Eligibility Criteria:
Inclusion Criteria:
* Recurrent pleural effusion at the computed tomography occupying at least 1/3 of the hemithorax in patients with recent history of malignancy.
* Karnofsky performance status ≥ 50
* ASA score II-III
* Acceptance of the randomly assigned anesthesia protocol
* Radiologic evidence of lung re-expansion after previous drainage/thoracentesis
* Absence of blood clotting disorders (INR \< 1.5)
* No contraindications to TEA
* No neurological or psychiatric disturbance contraindicating awake surgery
Exclusion Criteria:
* Patients refusal of random assignment to treatment arm
* Patients refusal or noncompliance to TEA
* Patients refusal or noncompliance to general anesthesia and one-lung ventilation
* Unfavourable anatomy for TEA
* Previous surgery of the thoracic spine
* Coagulation disorders (thromboplastin time \< 80%, prothrombin time \> 40 sec, platelet count \< 200/nL or bleeding disorders
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01469728
Study Brief:
Protocol Section:
NCT01469728