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 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
NCT ID:
NCT00758316
Eligibility Criteria:
Inclusion criteria:
1. Patients aged ≥ 18 with suspected or known symptomatic malignant pleural effusions (i.e. age \>60 or smoking history \> 20 pack years or moderate effusion \>1/3 hemithorax)
2. Ability and willingness to sign informed consent. See Annex 1 for patient information sheet and informed consent form.
3. Absence of contraindications to thoracoscopy and tunnelled pleural catheters
4. Willingness to comply with follow-up i.e. outpatient follow-up at 1 week and at 1 month for standard intervention; and additional every other day drainage in the intervention group (up to 5 times).
Exclusion criteria:
1. Uncorrected coagulopathy with platelet count ≤ 60 and INR ≥ 1.5.
2. Uncontrolled coughing because of risk of lung puncture and air leaks
3. Severe hypoxemia with a PaO2/FiO2 ratio ≤ 200 or hypercapnia with a PaCO2 ≥ 60 mmHg.
4. Unstable cardiovascular status ie. hemodynamic instability requiring inotropes/vasopressors, recent myocardial infarction \< 5 days or uncontrolled arrythmias
5. Uncontrolled psychiatric disorders or absence of a significant caregiver both of which will contraindicate sending the patient home with a tunnelled catheter
6. Previous thoracic surgery/intervention to the affected hemothorax which may have obliterated the pleural space
7. Local skin infections that prevent long term catheter placement
8. Morbid obesity which will increase risks associated with moderate sedation in the endoscopy centre
9. Multi-loculated effusions that will not benefit from drainage
10. Suspected pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00758316
Study Brief:
Protocol Section:
NCT00758316