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

Lung Cancer Clinical Trial

— CPAP-RFP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02117908
• Other study ID #: CPAP-RFP
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: February 21, 2018

Study information

• Verified date: January 2018
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: February 21, 2018
• Est. primary completion date: February 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atelectasis
• Lung Cancer
• Lung Neoplasms
• Pulmonary Atelectasis

Intervention

Device:
• RESMED AUTOSET S9
Continuous positive pressure during surgery

Locations

Country	Name	City	State
Spain	Hospital Clinic of Barcelona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Sara Varea	Spanish Ministry of Economy and competitivity

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prevention of atelectasis.	Atelectasic area Normal ventilation pulmonary area Hypoventilation pulmonary area Hyperventilation pulmonary area Bronchial wall injury distance	during surgery
Secondary	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
Secondary	Treatment success	Tumor ablation range, measured in CT3.	Measurement time: CT3
Secondary	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