Lung CancerCPAPNCT01285648
Study of CPAP as Intervention After Lung Resection
A study testing Cpap in people with Lung Cancer and Pulmonary Complications, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
The aim of this study was to compare the oxygenation index (OI), dyspnea, and pain scale and evaluate the duration of thoracic drainage and pleural air leaks after lung resection in two groups of patients: chest physiotherapy (CP) patients and combined CP and Continuous Positive Airway Pressure (CPAP) patients. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Lung Cancer, Pulmonary Complications
- What is being tested?
- Cpap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2007to Feb 2010
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medical diagnosis of lung cancer and an indication for lung resection (lobectomy, bilobectomy and pneumonectomy) with posterolateral thoracotomy;
- aged between 40 and 75 years.
Who cannot join
- Patients who refused to participate in the survey;
- lung resection with incisions other than posterolateral;
- patients who had contraindications to the use of noninvasive ventilation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: APPLICATION OF CONTINUOUS POSITIVE AIRWAY PRESSURE IN POSTOPERATIVE OF LUNG RESECTION
The aim of this study was to compare the oxygenation index (OI), dyspnea, and pain scale and evaluate the duration of thoracic drainage and pleural air leaks after lung resection in two groups of patients: chest physiotherapy (CP) patients and combined CP and Continuous Positive Airway Pressure (CPAP) patients.
Read the detailed description
In pulmonary resection surgery complications that lead to significant functional losses of the lung parenchyma and alterations in the ventilatory function may trigger retention of secretions, atelectasis, pneumonia and respiratory failure, which prolong the duration of mechanical ventilation and hospitalisation and contribute to the increase in risk of mortality.
In this study the oxygenation index (OI), Borg Scale, pain scale and the presence and duration of thoracic drainage was determined in the immediate postoperative (POi) period and in the first and second postoperative (PO1, PO2) days in 40 patients who underwent elective lung resection.
Similar to Chest Physiotherapy, the preventive application of CPAP in the postoperative period after lung resection in our study also appeared to be a safe technique, which allowed improved oxygenation without increasing air leaks through the thoracic drains.
- Conditions
- Lung Cancer, Pulmonary Complications
- Being tested
- Cpap
- Keywords
- chest tubes,, Continuous Positive Airway Pressure,, lung resection, thoracic surgery,, noninvasive ventilation,, postoperative
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CpapProcedure or surgery
Also called Noninvasive ventilation, lung resection
This study did not involved drugs. The Oxygenation index, Borg Scale, pain scale and the presence and duration of thoracic drainage was determined in the immediate postoperative (POi) period and in the first and second postoperative (PO1, PO2) days in 40 patients who underwent elective lung resection,in two groups of intervention: chest physiotherapy, and associate this with cpap
| Study group | Role | What they receive |
|---|---|---|
| Cpap | Other | This group joined chest physiotherapy with CPAP via nasal masks for two hours.CPAP was continued from the immediate postoperative day until the second postoperative day, twice a day. Receives: Procedure: Cpap |
| Chest Physiotherapy | Other | Chest Physiotherapy consisted of bronchial hygiene techniques and pulmonary expansion, in addition to exercises, and received oxygen supplementation to maintain the pulse oxymetry saturations > 90%. Receives: Procedure: Cpap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bubbling drains
From the immediate postoperative day until hospital discharge, the presence of chest tubes and the occurrence of air leaks in them as evidenced by the bubbling of the water seal were recorded. The maintenance and removal of drains or their use with wall suction were determined by applying the medical protocol of the institution through the analysis of X-rays and the amount of drained fluid.
Measured: From immediate postoperative until fifth, along the study, in a total of one year
Secondary outcomes (1)
Pain score
Before beginning the chest physiotherapy protocols, the patient was asked to rate their pain from zero to ten according to its intensity (the larger the score, the greater the intensity of pain).
Measured: Reported pain score after lung resection, along the study, during one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2011 (estimated)
- Study startNov 2007
- Primary completionDec 2009
- Study completionFeb 2010
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 Lung CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Investigators
- Lígia S. Roceto, Principal investigator, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285648
- Sponsor's protocol ID
- ROCETO130682
- Acronym
- CPAP
- Status last verified
- Jan 2011
- First submitted
- 25 Jan 2011
- Last updated
- 28 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roceto Ldos S, Galhardo FD, Saad IA, Toro IF. Continuous positive airway pressure (CPAP) after lung resection: a randomized clinical trial. Sao Paulo Med J. 2014;132(1):41-7. doi: 10.1590/1516-3180.2014.1321525.
PubMed 24474079
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APPLICATION OF CONTINUOUS POSITIVE AIRWAY PRESSURE IN POSTOPERATIVE OF LUNG RESECTION
- ClinicalTrials.gov ID
- NCT01285648
- Acronym / sponsor ID
- CPAP / ROCETO130682
- Conditions
- Lung Cancer, Pulmonary Complications
- Keywords
- chest tubes,, Continuous Positive Airway Pressure,, lung resection, thoracic surgery,, noninvasive ventilation,, postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 28 Jan 2011 (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 aim of this study was to compare the oxygenation index (OI), dyspnea, and pain scale and evaluate the duration of thoracic drainage and pleural air leaks after lung resection in two groups of patients: chest physiotherapy (CP) patients and combined CP and Continuous Positive Airway Pressure (CPAP) patients.
Detailed description
In pulmonary resection surgery complications that lead to significant functional losses of the lung parenchyma and alterations in the ventilatory function may trigger retention of secretions, atelectasis, pneumonia and respiratory failure, which prolong the duration of mechanical ventilation and hospitalisation and contribute to the increase in risk of mortality.
In this study the oxygenation index (OI), Borg Scale, pain scale and the presence and duration of thoracic drainage was determined in the immediate postoperative (POi) period and in the first and second postoperative (PO1, PO2) days in 40 patients who underwent elective lung resection.
Similar to Chest Physiotherapy, the preventive application of CPAP in the postoperative period after lung resection in our study also appeared to be a safe technique, which allowed improved oxygenation without increasing air leaks through the thoracic drains.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cpap | Other | Procedure: CpapThis group joined chest physiotherapy with CPAP via nasal masks for two hours.CPAP was continued from the immediate postoperative day until the second postoperative day, twice a day. |
| Chest Physiotherapy | Other | Procedure: CpapChest Physiotherapy consisted of bronchial hygiene techniques and pulmonary expansion, in addition to exercises, and received oxygen supplementation to maintain the pulse oxymetry saturations > 90%. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- medical diagnosis of lung cancer and an indication for lung resection (lobectomy, bilobectomy and pneumonectomy) with posterolateral thoracotomy;
- aged between 40 and 75 years.
Key exclusion criteria (3 listed)
- Patients who refused to participate in the survey;
- lung resection with incisions other than posterolateral;
- patients who had contraindications to the use of noninvasive ventilation.
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 |
|---|---|---|
| CpapAlso: Noninvasive ventilation, lung resectionThis study did not involved drugs. The Oxygenation index, Borg Scale, pain scale and the presence and duration of thoracic drainage was determined in the immediate postoperative (POi) period and in the first and second postoperative (PO1, PO2) days in 40 patients who underwent elective lung resection,in two groups of intervention: chest physiotherapy, and associate this with cpap | Procedure or surgery | Chest Physiotherapy, Cpap |
Primary outcome
Bubbling drains
Time frame: From immediate postoperative until fifth, along the study, in a total of one year
From the immediate postoperative day until hospital discharge, the presence of chest tubes and the occurrence of air leaks in them as evidenced by the bubbling of the water seal were recorded. The maintenance and removal of drains or their use with wall suction were determined by applying the medical protocol of the institution through the analysis of X-rays and the amount of drained fluid.
1 secondary outcome
Pain score
Time frame: Reported pain score after lung resection, along the study, during one year
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 28 Jan 2011.
- Derived from this study: PubMed 24474079Roceto Ldos S, Galhardo FD, Saad IA, Toro IF. Continuous positive airway pressure (CPAP) after lung resection: a randomized clinical trial. Sao Paulo Med J. 2014;132(1):41-7. doi: 10.1590/1516-3180.2014.1321525.
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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.
Lígia S. Roceto principal investigator
University of Campinas, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cpap in people with Lung Cancer and Pulmonary Complications, run by University of Campinas, Brazil at 1 site in Brazil.
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 3 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 28 Jan 2011. 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 Brazil. 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.
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?
Bubbling drains (time frame: From immediate postoperative until fifth, along the study, in a total of one year). 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 NCT01285648, 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 28 Jan 2011.