Lung ResectionPhase 4NCT02771327
Use of a Pressurized Face Mask for Preventing Respiratory Complications After Chest Surgery
A Phase 4 study testing CPAP plus Gas and ventimask plus gas in people with Lung Resection, run by Hospital General Universitario Gregorio Marañon at 4 sites in Spain.
Trial summary
Evaluation of efficacy and safety from 6hours of 7 cmH2O CPAP after weaning in patients undergoing lung resection, on the prevention of atelectasis / pneumonia and gas exchange improve. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Resection
- What is being tested?
- CPAP plus Gas and ventimask plus gas
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 4 sitesSpain
- Study dates
- Feb 2014to Sep 2016
- Phase
- Phase 4
- 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
- Undergoing thoracic surgery including resection of lung parenchyma.
- To have given signed consent to enter in the study.
Who cannot join
- Weaning in the first 4h after the intervention end.
- Suspected bronchopleural fistula at the admission to the surgical ICU.
- Patients with facial problems or a history of intolerance to CPAP masks.
- Having significant bullous emphysema defined as the presence of more than 5 contiguous bullae <2cm or the existence of a pulmonary bulla> 2 cm or dystrophy bullosa, not in the area to dry and having had a previous pneumothorax.
- Known Obstructive Apnea Hypopnea syndrome known or some form of noninvasive ventilation prescribed.
- Immunocompromised patients, or having used an immunosuppressor drug at least one month prior to surgery with potential (except corticosteroids administered by inhalation)
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hopsital universitario La Princesa
Madrid, Madrid, 28006
HGU Gregorio Marañón
Madrid, Madrid, 28007
H. Ramón y Cajal
Madrid, Madrid, 28034
HU 12 de octubre
Madrid, Madrid, 28041
About this study
Official title: Phase 4, Randomized, Controlled Trial on the Efficacy as Prophylaxis of Postoperative Respiratory Complications and Safety of Continuous Positive Airways Pressure (CPAP) Applied Throughout Boussignac Mask During the Immediate Postoperative Period of Patients Undergoing Lung Resection
Evaluation of efficacy and safety from 6hours of 7 cmH2O CPAP after weaning in patients undergoing lung resection, on the prevention of atelectasis / pneumonia and gas exchange improve.
Read the detailed description
Multicenter randomized clinical trial. 460 patients randomly assigned to treatment and control groups will be studied. The main variables are the frequency of atelectasis or pneumonia, defined by clinical and radiological criteria, the FiO2/PaO2 ratio, 7 and 24 h after weaning, and hospital stay.
- Conditions
- Lung Resection
- Being tested
- CPAP plus Gas, ventimask plus gas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP plus GasDevice
ventimask plus gasDevice
| Study group | Role | What they receive |
|---|---|---|
| CPAP plus gas | Experimental | Treatment with Boussingnac valve CPAP during 6 hour, starting immediately after weaning Receives: Device: CPAP plus Gas |
| Usual treatment(ventimask plus gas) | Active comparator | ventimask Receives: Device: ventimask plus gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of atelectasis- Pneumonia, and other postoperative complications,
Measured: 1 week after the surgical intervention
Secondary outcomes (2)
Gas exchange ( Pa/FiO2)
Measured: 1 week after the surgical intervention
Hospital stay comparison between arms
Measured: from the surgical intervention date to hospital discharge date up to 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startFeb 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung ResectionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771327
- Sponsor's protocol ID
- FIBHGM-ECNC010-2010
- Status last verified
- Nov 2016
- First submitted
- 4 Apr 2016
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4, Randomized, Controlled Trial on the Efficacy as Prophylaxis of Postoperative Respiratory Complications and Safety of Continuous Positive Airways Pressure (CPAP) Applied Throughout Boussignac Mask During the Immediate Postoperative Period of Patients Undergoing Lung Resection
- ClinicalTrials.gov ID
- NCT02771327
- Acronym / sponsor ID
- FIBHGM-ECNC010-2010
- Conditions
- Lung Resection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Feb 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 13 May 2016 (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.
Evaluation of efficacy and safety from 6hours of 7 cmH2O CPAP after weaning in patients undergoing lung resection, on the prevention of atelectasis / pneumonia and gas exchange improve.
Detailed description
Multicenter randomized clinical trial. 460 patients randomly assigned to treatment and control groups will be studied. The main variables are the frequency of atelectasis or pneumonia, defined by clinical and radiological criteria, the FiO2/PaO2 ratio, 7 and 24 h after weaning, and hospital stay.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP plus gas | Experimental | Device: CPAP plus GasTreatment with Boussingnac valve CPAP during 6 hour, starting immediately after weaning |
| Usual treatment(ventimask plus gas) | Active comparator | Device: ventimask plus gasventimask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing thoracic surgery including resection of lung parenchyma.
- To have given signed consent to enter in the study.
Key exclusion criteria (6 listed)
- Weaning in the first 4h after the intervention end.
- Suspected bronchopleural fistula at the admission to the surgical ICU.
- Patients with facial problems or a history of intolerance to CPAP masks.
- Having significant bullous emphysema defined as the presence of more than 5 contiguous bullae <2cm or the existence of a pulmonary bulla> 2 cm or dystrophy bullosa, not in the area to dry and having had a previous pneumothorax.
- Known Obstructive Apnea Hypopnea syndrome known or some form of noninvasive ventilation prescribed.
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 |
|---|---|---|
| CPAP plus Gas | Device | CPAP plus gas |
| ventimask plus gas | Device | Usual treatment(ventimask plus gas) |
Primary outcome
Frequency of atelectasis- Pneumonia, and other postoperative complications,
Time frame: 1 week after the surgical intervention
2 secondary outcomes
Gas exchange ( Pa/FiO2)
Time frame: 1 week after the surgical intervention
Hospital stay comparison between arms
Time frame: from the surgical intervention date to hospital discharge date up to 1month
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 18 Nov 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CPAP plus Gas and ventimask plus gas in people with Lung Resection, run by Hospital General Universitario Gregorio Marañon at 4 sites 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 2 inclusion and 6 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 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Frequency of atelectasis- Pneumonia, and other postoperative complications, (time frame: 1 week after the surgical intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2016.