Application of CPAP to Reduce Complications and Improve Treatment of Radiofrequency Ablation of Lung Cancer Under Conscious Sedation. A Randomized Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atelectasis
- Sponsor
- Sara Varea
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Number of Participants with Adverse Events as a Measure of Safety
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The project aims to study whether the application of a continuous positive airway pressure (CPAP) of 4 cm water vapor is a safe method in pulmonary radiofrequency intervention (PRF) lung cancer under conscious sedation compared with placebo. And, assess whether CPAP prevents atelectasis formation and consequently reduces the potential complications of PRF and improves procedural success
Investigators
Sara Varea
Clinical Research Manager
Fundacion Clinic per a la Recerca Biomédica
Eligibility Criteria
Inclusion Criteria
- •male and female aged 18 years and older
- •Patient with a scheduled intervention for ablation of pulmonary malignant tumor with radiofrequency .
- •Patient able to undergo tests and examinations required by the study.
Exclusion Criteria
- •Patients with CPAP intolerance test.
- •Patients with progressive disease in which local treatment is not applicable
- •Patients with intercurrent process (pleural effusion, pneumonia, ...).
- •Patient unable to understand the proceedings.
- •Pregnancy or breastfeeding.
Outcomes
Primary Outcomes
Number of Participants with Adverse Events as a Measure of Safety
Time Frame: thirty days
Patients with any of the following complications Pulmonary over-distention along intervention Pneumothorax along intervention Bronchial fistulas measures Computed tomography (CT)1, CT2 and CT3 Vomiting along intervention Decrease in MAP (mean arterial pressure) \> 20% measured in the intraoperative period Assay of each of the previous complications
Secondary Outcomes
- Treatment success(Measurement time: CT3)
- Prevention of atelectasis.(during surgery)
- Decrease associated complications with PFR. Measurement times: intraoperative, PACU (post-anesthesic care unit), hospital discharge, day 15 and day 30.(thirty days)
- Predictors factors of the occurrence of complications during PRA (pulmonary radiofrequency ablation).(thirty days)