Study of the Application of CPAP to Reduce Complications and Improve Lung Cancer Ablation Radiofrequency Treatment

Study Overview
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Brief Summary
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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

Official Title
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Application of CPAP to Reduce Complications and Improve Treatment of Radiofrequency Ablation of Lung Cancer Under Conscious Sedation. A Randomized Study

Conditions
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Atelectasis, Lung Cancer

Intervention / Treatment
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* Device: RESMED AUTOSET S9


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP +4 cm H2O<br>CPAP +4 cm H2O pressure using ResMedTM face mask | Device: RESMED AUTOSET S9<br>* Continuous positive pressure during surgery<br>|
| Sham Comparator: ShamCPAP<br>shamCPAP using ResMedTM CPAP face mask modified for technical sham | Device: RESMED AUTOSET S9<br>* Continuous positive pressure during surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety | 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 | thirty days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of atelectasis. | Atelectasic area Normal ventilation pulmonary area Hypoventilation pulmonary area Hyperventilation pulmonary area Bronchial wall injury distance | during surgery | 
| Decrease associated complications with PFR. Measurement times: intraoperative, PACU (post-anesthesic care unit), hospital discharge, day 15 and day 30. | 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. | thirty days | 
| Treatment success | Tumor ablation range, measured in CT3. | Measurement time: CT3 | 
| Predictors factors of the occurrence of complications during PRA (pulmonary radiofrequency ablation). | 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. | thirty days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention, radiofrequency treatment, lung cancer ablation