Atelectasis, Lung Cancer
Conditions
Keywords
prevention, radiofrequency treatment, lung cancer ablation
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
Interventions
DEVICERESMED AUTOSET S9
Continuous positive pressure during surgery
Sponsors
Ministerio de Economía y Competitividad, Spain
Sara Varea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety | 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
| Measure | Time frame | Description |
|---|---|---|
| Prevention of atelectasis. | during surgery | Atelectasic area Normal ventilation pulmonary area Hypoventilation pulmonary area Hyperventilation pulmonary area Bronchial wall injury distance |
| Decrease associated complications with PFR. Measurement times: intraoperative, PACU (post-anesthesic care unit), hospital discharge, day 15 and day 30. | thirty days | Major complications (death, failure to complete treatment, need for manual ventilation, intubation or resuscitation, pulmonary hemorrhage, need for pleural drainage, shock, fistulas, nerve injury, diaphragmatic injury, persistent pain, infections, increased hospitalization time and readmission rates) and any classified as a serious adverse event. |
| Treatment success | Measurement time: CT3 | Tumor ablation range, measured in CT3. |
| Predictors factors of the occurrence of complications during PRA (pulmonary radiofrequency ablation). | thirty days | Minor complications (transient episodes of hypoxemia, apnea / hypoventilation or hypotension, pneumothorax without clinic symptoms or drainage, increased need for sedation, longer procedure) and any other event adverse not classified as serious. |
Countries
Spain
Outcome results
None listed