NCT02117908

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2018

Completed
Last Updated

July 24, 2018

Status Verified

January 1, 2018

Enrollment Period

3.3 years

First QC Date

April 11, 2014

Last Update Submit

July 23, 2018

Conditions

AtelectasisLung Cancer

Keywords

preventionradiofrequency treatmentlung cancer ablation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Prevention of atelectasis.

    during surgery

  • Decrease associated complications with PFR. Measurement times: intraoperative, PACU (post-anesthesic care unit), hospital discharge, day 15 and day 30.

    thirty days

  • Treatment success

    Measurement time: CT3

  • Predictors factors of the occurrence of complications during PRA (pulmonary radiofrequency ablation).

    thirty days

Study Arms (2)

CPAP +4 cm H2O

EXPERIMENTAL

CPAP +4 cm H2O pressure using ResMedTM face mask

Device: RESMED AUTOSET S9

ShamCPAP

SHAM COMPARATOR

shamCPAP using ResMedTM CPAP face mask modified for technical sham

Device: RESMED AUTOSET S9

Interventions

RESMED AUTOSET S9DEVICE

Continuous positive pressure during surgery

CPAP +4 cm H2OShamCPAP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

Location

Related Publications (1)

  • Carrero-Cardenal E, Vollmer-Torrubiano I, Torres-Lopez M, Martin-Barrera G, Casanovas-Mateu G, Tercero-Machin FJ, Paez-Carpio A, Fabregas-Julia N, Valero-Castell R. Continuous positive airway pressure is unsafe for radiofrequency ablation of lung cancer under sedation: a randomised controlled trial. Insights Imaging. 2024 Jun 20;15(1):153. doi: 10.1186/s13244-024-01721-9.

    PMID: 38900225DERIVED

MeSH Terms

Conditions

Pulmonary AtelectasisLung Neoplasms

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Enrique J Carrero Cardenal, MD PhD

    Hospital Clínic i Provincial de Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Research Manager

Study Record Dates

First Submitted

April 11, 2014

First Posted

April 21, 2014

Study Start

November 1, 2014

Primary Completion

February 21, 2018

Study Completion

February 21, 2018

Last Updated

July 24, 2018

Record last verified: 2018-01

Locations

ES(1)