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| Name | Class |
|---|---|
| Ministerio de EconomÃa y Competitividad, Spain | OTHER_GOV |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP +4 cm H2O | Experimental | CPAP +4 cm H2O pressure using ResMedTM face mask |
|
| ShamCPAP | Sham Comparator | shamCPAP using ResMedTM CPAP face mask modified for technical sham |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RESMED AUTOSET S9 | Device | Continuous positive pressure during surgery |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enrique J Carrero Cardenal, MD PhD | Hospital ClÃnic i Provincial de Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic of Barcelona | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38900225 | Derived | Carrero-Cardenal E, Vollmer-Torrubiano I, Torres-Lopez M, Martin-Barrera G, Casanovas-Mateu G, Tercero-Machin FJ, Paez-Carpio A, Fabregas-Julia N, Valero-Castell R. Continuous positive airway pressure is unsafe for radiofrequency ablation of lung cancer under sedation: a randomised controlled trial. Insights Imaging. 2024 Jun 20;15(1):153. doi: 10.1186/s13244-024-01721-9. |
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| ID | Term |
|---|---|
| D001261 | Pulmonary Atelectasis |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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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 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |