Pulmonary Resection SurgeryNCT01826136
Effect of Vibratory Expiratory Pressure on Pulmonary Function After Lung Resection Surgery
A study testing Acapella device in people with Pulmonary Resection Surgery, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Postoperative airway clearance and recovery of pulmonary function after lung resection is critical in patients undergoing pulmonary resection surgery. The investigators hypothesized that vibratory positive expiratory pressure using the Acapella device may improve pulmonary function recovery in patients undergoing… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Pulmonary Resection Surgery
- What is being tested?
- Acapella device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to Sep 2013
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients between 20 and 65 years old
- undergoing video-assisted thoracoscopic lung resection surgery for suspicious lung cancer
- admission to intensive care unit in extubate state
- with intravenous patient-controlled analgesia
Who cannot join
- body mass index of less than 15 kg/m2 or more than 30 kg/m2
- history of respiratory tract infection within 3 months
- emergency surgery
- preoperative supplemental oxygen or ventilator care
- preoperative PaO2 of less than 70 mmHg or PaCO2 of more than 50 mmHg
- preoperative FEV1 of less than 30% of predicted value
- unconsciousness or neuromuscular disease
Trial locations and contacts
1 site in 1 country.
About this study
Postoperative airway clearance and recovery of pulmonary function after lung resection is critical in patients undergoing pulmonary resection surgery. The investigators hypothesized that vibratory positive expiratory pressure using the Acapella device may improve pulmonary function recovery in patients undergoing video-assisted thoracoscopic lung resection surgery.
- Conditions
- Pulmonary Resection Surgery
- Being tested
- Acapella device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acapella deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Acapella | Experimental | use of the Acapella device postoperatively Receives: Device: Acapella device |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 on the third postoperative day
Measured: 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Resection SurgeryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826136
- Sponsor's protocol ID
- YSJeon_Acapella
- Status last verified
- May 2014
- First submitted
- 3 Apr 2013
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vibratory Expiratory Pressure on Pulmonary Function After Lung Resection Surgery
- ClinicalTrials.gov ID
- NCT01826136
- Acronym / sponsor ID
- YSJeon_Acapella
- Conditions
- Pulmonary Resection Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 8 Apr 2013 (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.
Postoperative airway clearance and recovery of pulmonary function after lung resection is critical in patients undergoing pulmonary resection surgery. The investigators hypothesized that vibratory positive expiratory pressure using the Acapella device may improve pulmonary function recovery in patients undergoing video-assisted thoracoscopic lung resection surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acapella | Experimental | Device: Acapella deviceuse of the Acapella device postoperatively |
| Control | No intervention | – |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients between 20 and 65 years old
- undergoing video-assisted thoracoscopic lung resection surgery for suspicious lung cancer
- admission to intensive care unit in extubate state
- with intravenous patient-controlled analgesia
Key exclusion criteria (7 listed)
- body mass index of less than 15 kg/m2 or more than 30 kg/m2
- history of respiratory tract infection within 3 months
- emergency surgery
- preoperative supplemental oxygen or ventilator care
- preoperative PaO2 of less than 70 mmHg or PaCO2 of more than 50 mmHg
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 |
|---|---|---|
| Acapella device | Device | Acapella |
Primary outcome
FEV1 on the third postoperative day
Time frame: 3 days after surgery
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 14 May 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acapella device in people with Pulmonary Resection Surgery, run by Seoul National University Hospital at 1 site in South Korea.
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 4 inclusion and 7 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 14 May 2014. 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 South Korea. 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?
FEV1 on the third postoperative day (time frame: 3 days after surgery). 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 14 May 2014.