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

July 23, 2018 updated by: Sara Varea

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic of Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevention of atelectasis.
Time Frame: during surgery
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.
Time Frame: 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.
thirty days
Treatment success
Time Frame: Measurement time: CT3
Tumor ablation range, measured in CT3.
Measurement time: CT3
Predictors factors of the occurrence of complications during PRA (pulmonary radiofrequency ablation).
Time Frame: 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.
thirty days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sara Varea

Collaborators

Ministerio de Economía y Competitividad, Spain

Investigators

  • Principal Investigator: Enrique J Carrero Cardenal, MD PhD, Hospital Clínic i Provincial de Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

February 21, 2018

Study Completion (Actual)

February 21, 2018

Study Registration Dates

First Submitted

April 11, 2014

First Submitted That Met QC Criteria

April 16, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Actual)

July 24, 2018

Last Update Submitted That Met QC Criteria

July 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPAP-RFP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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