Study of the Application of CPAP to Reduce Complications and Improve Lung Cancer Ablation Radiofrequency Treatment (CPAP-RFP)

Sara Varea

Status: Completed

Conditions: Atelectasis; Lung Cancer

Treatments: Device: RESMED AUTOSET S9

Study type: Interventional

Funder types: Other

Identifiers

NCT02117908

CPAP-RFP

Details and patient eligibility

About

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

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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47 participants in 2 patient groups

CPAP +4 cm H2O

Experimental group

Description:

CPAP +4 cm H2O pressure using ResMedTM face mask

Treatment:

Device: RESMED AUTOSET S9

ShamCPAP

Sham Comparator group

Description:

shamCPAP using ResMedTM CPAP face mask modified for technical sham

Treatment:

Device: RESMED AUTOSET S9