AtelectasisCPAP-RFPNCT02117908
Study of the Application of CPAP to Reduce Complications and Improve Lung Cancer Ablation Radiofrequency Treatment
A study testing RESMED AUTOSET S9 in people with Atelectasis and Lung Cancer, run by Sara Varea at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atelectasis, Lung Cancer
- What is being tested?
- RESMED AUTOSET S9
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2014to 21 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Atelectasis, Lung Cancer
- Being tested
- RESMED AUTOSET S9
- Keywords
- prevention, radiofrequency treatment, lung cancer ablation
- Medical subject headings
- Pulmonary Atelectasis, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESMED AUTOSET S9Device
Continuous positive pressure during surgery
| Study group | Role | What they receive |
|---|---|---|
| CPAP +4 cm H2O | Experimental | CPAP +4 cm H2O pressure using ResMedTM face mask Receives: Device: RESMED AUTOSET S9 |
| ShamCPAP | Sham comparator | shamCPAP using ResMedTM CPAP face mask modified for technical sham Receives: Device: RESMED AUTOSET S9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: thirty days
Secondary outcomes (4)
Prevention of atelectasis.
Atelectasic area Normal ventilation pulmonary area Hypoventilation pulmonary area Hyperventilation pulmonary area Bronchial wall injury distance
Measured: during surgery
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.
Measured: thirty days
Treatment success
Tumor ablation range, measured in CT3.
Measured: Measurement time: 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.
Measured: thirty days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startNov 2014
- Primary completion21 Feb 2018
- Study completion21 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Varea
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Responsible party
- Sponsor-investigator, Sara Varea, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Enrique J Carrero Cardenal, MD PhD, Principal investigator, Hospital Clínic i Provincial de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117908
- Sponsor's protocol ID
- CPAP-RFP
- Acronym
- CPAP-RFP
- Status last verified
- Jan 2018
- First submitted
- 11 Apr 2014
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38900225
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of CPAP to Reduce Complications and Improve Treatment of Radiofrequency Ablation of Lung Cancer Under Conscious Sedation. A Randomized Study
- ClinicalTrials.gov ID
- NCT02117908
- Acronym / sponsor ID
- CPAP-RFP / CPAP-RFP
- Conditions
- Atelectasis, Lung Cancer
- Keywords
- prevention, radiofrequency treatment, lung cancer ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Sara VareaUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Study start
- Nov 2014 (actual)
- Primary completion
- 21 Feb 2018 (actual)
- Study completion
- 21 Feb 2018 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP +4 cm H2O | Experimental | Device: RESMED AUTOSET S9CPAP +4 cm H2O pressure using ResMedTM face mask |
| ShamCPAP | Sham comparator | Device: RESMED AUTOSET S9shamCPAP using ResMedTM CPAP face mask modified for technical sham |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RESMED AUTOSET S9Continuous positive pressure during surgery | Device | CPAP +4 cm H2O, ShamCPAP |
Primary outcome
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
4 secondary outcomes
Prevention of atelectasis.
Time frame: 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
Treatment success
Time frame: Measurement time: CT3
Predictors factors of the occurrence of complications during PRA (pulmonary radiofrequency ablation).
Time frame: thirty days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Derived from this study: PubMed 38900225Carrero-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrique J Carrero Cardenal, MD PhD principal investigator
Hospital Clínic i Provincial de Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESMED AUTOSET S9 in people with Atelectasis and Lung Cancer, run by Sara Varea at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events as a Measure of Safety (time frame: thirty days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02117908, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.