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

Not Applicable

Completed

• Conditions: Lung Cancer; Atelectasis
• Interventions: Device: RESMED AUTOSET S9

• Registration Number: NCT02117908
• Lead Sponsor: Sara Varea

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-11
• Study First Submitted QC: 2014-04-16
• Study First Posted: 2014-04-21
• Study Start: 2014-11
• Status Verified: 2018-01
• Primary Completion: 2018-02-21
• Study Completion: 2018-02-21
• Last Update Submitted: 2018-07-23
• Last Update Posted: 2018-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ShamCPAP	RESMED AUTOSET S9	shamCPAP using ResMedTM CPAP face mask modified for technical sham
CPAP +4 cm H2O	RESMED AUTOSET S9	CPAP +4 cm H2O pressure using ResMedTM face mask

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Treatment success	Measurement time: CT3	Tumor ablation range, measured in CT3.
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.
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.

Trial Locations

Locations (1)

Hospital Clinic of Barcelona; 🇪🇸 Barcelona, Spain