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

Primary Purpose

Atelectasis, Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
RESMED AUTOSET S9
Sponsored by
Sara Varea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atelectasis focused on measuring prevention, radiofrequency treatment, lung cancer ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Clinic of Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

CPAP +4 cm H2O

ShamCPAP

Arm Description

CPAP +4 cm H2O pressure using ResMedTM face mask

shamCPAP using ResMedTM CPAP face mask modified for technical sham

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Prevention of atelectasis.
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.
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.
Treatment success
Tumor ablation range, measured in 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.

Full Information

First Posted
April 11, 2014
Last Updated
July 23, 2018
Sponsor
Sara Varea
Collaborators
Ministerio de Economía y Competitividad, Spain
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1. Study Identification

Unique Protocol Identification Number
NCT02117908
Brief Title
Study of the Application of CPAP to Reduce Complications and Improve Lung Cancer Ablation Radiofrequency Treatment
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
February 21, 2018 (Actual)
Study Completion Date
February 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sara Varea
Collaborators
Ministerio de Economía y Competitividad, Spain

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis, Lung Cancer
Keywords
prevention, radiofrequency treatment, lung cancer ablation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPAP +4 cm H2O
Arm Type
Experimental
Arm Description
CPAP +4 cm H2O pressure using ResMedTM face mask
Arm Title
ShamCPAP
Arm Type
Sham Comparator
Arm Description
shamCPAP using ResMedTM CPAP face mask modified for technical sham
Intervention Type
Device
Intervention Name(s)
RESMED AUTOSET S9
Intervention Description
Continuous positive pressure during surgery
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety
Description
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
Time Frame
thirty days
Secondary Outcome Measure Information:
Title
Prevention of atelectasis.
Description
Atelectasic area Normal ventilation pulmonary area Hypoventilation pulmonary area Hyperventilation pulmonary area Bronchial wall injury distance
Time Frame
during surgery
Title
Decrease associated complications with PFR. Measurement times: intraoperative, PACU (post-anesthesic care unit), hospital discharge, day 15 and day 30.
Description
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.
Time Frame
thirty days
Title
Treatment success
Description
Tumor ablation range, measured in CT3.
Time Frame
Measurement time: CT3
Title
Predictors factors of the occurrence of complications during PRA (pulmonary radiofrequency ablation).
Description
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.
Time Frame
thirty days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique J Carrero Cardenal, MD PhD
Organizational Affiliation
Hospital Clínic i Provincial de Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic of Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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