Lung Function DecreasedPLFNCT03054675
Perioperative Lung Function Monitoring After Anatomic Lung Resections
An observational study of Lung Function Decreased and Lung Diseases, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Aim of this study was to prospectively investigate the correlation between postoperative spirometry values and pulmonary complications after anatomic lung resections. In addition, the investigators compared postoperative pulmonary function changes between open and minimally invasive approaches. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Function Decreased, Lung Diseases, Surgery
- What is being tested?
- Spirometry
- How many people
- 328 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2013to 30 Jun 2016
- Phase
- Observational
- 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
Study population: All patients undergoing an anatomical lung resection at our institution
Who may be able to join
- Patients undergoing anatomical lung resection
- Written informed consent
Who cannot join
- Underage patients
- Extended resections including resection of chest wall or diaphragm
- Bronchoplastic resections
Trial locations and contacts
1 site in 1 country.
About this study
Aim of this study was to prospectively investigate the correlation between postoperative spirometry values and pulmonary complications after anatomic lung resections. In addition, the investigators compared postoperative pulmonary function changes between open and minimally invasive approaches.
Read the detailed description
All patients undergoing an anatomical lung resection at the investigators' institution were evaluated for this study. Underage patients and those undergoing extended resections (including resection of the chest wall and/or diaphragm) and/or bronchoplastic procedures were excluded.
In every eligible patient undergoing an anatomic lung resection, preoperative spirometry was performed using a handheld spirometer on the day before surgery and on every second day after surgery was performed until patient discharge. The absolute values of FEV1 were recorded by an independent study nurse and noted on a separate sheet not available to the treating doctors.
At the end of the study period FEV1 values were evaluated especially with focus on their correlation with postoperative pulmonary complications (i.e. pneumonia, acute exacerbation of COPD, air leak and atelectasis). Furthermore lung function values of patients undergoing 'open' resections were compared with patients undergoing minimally invasive resections.
- Conditions
- Lung Function Decreased, Lung Diseases, Surgery
- Being tested
- Spirometry
- Keywords
- lung resection, lung function, VATS, Thoracotomy
- Medical subject headings
- Respiratory Insufficiency, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirometryDiagnostic test
Absolute FEV1 is measured in every patient using a handheld spirometer
| Study group | Role | What they receive |
|---|---|---|
| Pneumonia | Patients suffering from postoperative pneumonia including all three of the following:
1. Clinical signs of a pulmonary infection (i.e. fever ≥ 38°C combined with productive cough and/or dyspnea)
2. A new rise of inflammatory markers (i.e. WBC count ≥ 10.5 x 109 and elevated CRP)
3. New radiographic infiltrates on chest x-ray without another explanation. Patients with pneumonia undergo spirometry before and on every second day after lung surgery Receives: Diagnostic Test: Spirometry | |
| No Pneumonia | Patients without pneumonia undergo spirometry before and on every second day after lung surgery Receives: Diagnostic Test: Spirometry | |
| Open (no pneumonia) | Patients undergoing open anatomical lung resection who did not show postoperative pneumonia.
All patients undergo spirometry before and on every second day after lung surgery. Receives: Diagnostic Test: Spirometry | |
| Minimally invasive (no pneumonia) | Patients undergoing minimally invasive anatomical lung resection who did not show postoperative pneumonia.
All patients undergo spirometry before and on every second day after lung surgery. Receives: Diagnostic Test: Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in FEV1
Postoperative loss of FEV1 in percent of absolute preoperative levels
Measured: up to 6 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 posted15 Feb 2017
- Study start1 Jun 2013
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung Function DecreasedStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregor J Kocher, MD, Principal investigator, Division of General Thoracic Surgery, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054675
- Sponsor's protocol ID
- 266/15
- Acronym
- PLF
- Status last verified
- Feb 2017
- First submitted
- 13 Feb 2017
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ercegovac M, Subotic D, Zugic V, Jakovic R, Moskovljevic D, Bascarevic S, Mujovic N. Postoperative complications do not influence the pattern of early lung function recovery after lung resection for lung cancer in patients at risk. J Cardiothorac Surg. 2014 May 19;9:92. doi: 10.1186/1749-8090-9-92.
PubMed 24884793Nakata M, Saeki H, Yokoyama N, Kurita A, Takiyama W, Takashima S. Pulmonary function after lobectomy: video-assisted thoracic surgery versus thoracotomy. Ann Thorac Surg. 2000 Sep;70(3):938-41. doi: 10.1016/s0003-4975(00)01513-7.
PubMed 11016337Schussler O, Alifano M, Dermine H, Strano S, Casetta A, Sepulveda S, Chafik A, Coignard S, Rabbat A, Regnard JF. Postoperative pneumonia after major lung resection. Am J Respir Crit Care Med. 2006 May 15;173(10):1161-9. doi: 10.1164/rccm.200510-1556OC. Epub 2006 Feb 10.
PubMed 16474029
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Lung Function Monitoring After Anatomic Lung Resections
- ClinicalTrials.gov ID
- NCT03054675
- Acronym / sponsor ID
- PLF / 266/15
- Conditions
- Lung Function Decreased, Lung Diseases, Surgery
- Keywords
- lung resection, lung function, VATS, Thoracotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 15 Feb 2017 (actual)
- 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.
Aim of this study was to prospectively investigate the correlation between postoperative spirometry values and pulmonary complications after anatomic lung resections. In addition, the investigators compared postoperative pulmonary function changes between open and minimally invasive approaches.
Detailed description
All patients undergoing an anatomical lung resection at the investigators' institution were evaluated for this study. Underage patients and those undergoing extended resections (including resection of the chest wall and/or diaphragm) and/or bronchoplastic procedures were excluded.
In every eligible patient undergoing an anatomic lung resection, preoperative spirometry was performed using a handheld spirometer on the day before surgery and on every second day after surgery was performed until patient discharge. The absolute values of FEV1 were recorded by an independent study nurse and noted on a separate sheet not available to the treating doctors.
At the end of the study period FEV1 values were evaluated especially with focus on their correlation with postoperative pulmonary complications (i.e. pneumonia, acute exacerbation of COPD, air leak and atelectasis). Furthermore lung function values of patients undergoing 'open' resections were compared with patients undergoing minimally invasive resections.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pneumonia | – | Diagnostic Test: SpirometryPatients suffering from postoperative pneumonia including all three of the following: 1. Clinical signs of a pulmonary infection (i.e. fever ≥ 38°C combined with productive cough and/or dyspnea) 2. A new rise of inflammatory markers (i.e. WBC count ≥ 10.5 x 109 and elevated CRP) 3. New radiographic infiltrates on chest x-ray without another explanation. Patients with pneumonia undergo spirometry before and on every second day after lung surgery |
| No Pneumonia | – | Diagnostic Test: SpirometryPatients without pneumonia undergo spirometry before and on every second day after lung surgery |
| Open (no pneumonia) | – | Diagnostic Test: SpirometryPatients undergoing open anatomical lung resection who did not show postoperative pneumonia. All patients undergo spirometry before and on every second day after lung surgery. |
| Minimally invasive (no pneumonia) | – | Diagnostic Test: SpirometryPatients undergoing minimally invasive anatomical lung resection who did not show postoperative pneumonia. All patients undergo spirometry before and on every second day after lung surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing an anatomical lung resection at our institution
Key inclusion criteria (2 listed)
- Patients undergoing anatomical lung resection
- Written informed consent
Key exclusion criteria (3 listed)
- Underage patients
- Extended resections including resection of chest wall or diaphragm
- Bronchoplastic resections
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 |
|---|---|---|
| SpirometryAbsolute FEV1 is measured in every patient using a handheld spirometer | Diagnostic test | Minimally invasive (no pneumonia), No Pneumonia, Open (no pneumonia), Pneumonia |
Primary outcome
Decrease in FEV1
Time frame: up to 6 days after surgery
Postoperative loss of FEV1 in percent of absolute preoperative levels
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 15 Feb 2017.
- Background: PubMed 24884793Ercegovac M, Subotic D, Zugic V, Jakovic R, Moskovljevic D, Bascarevic S, Mujovic N. Postoperative complications do not influence the pattern of early lung function recovery after lung resection for lung cancer in patients at risk. J Cardiothorac Surg. 2014 May 19;9:92. doi: 10.1186/1749-8090-9-92.
- Background: PubMed 11016337Nakata M, Saeki H, Yokoyama N, Kurita A, Takiyama W, Takashima S. Pulmonary function after lobectomy: video-assisted thoracic surgery versus thoracotomy. Ann Thorac Surg. 2000 Sep;70(3):938-41. doi: 10.1016/s0003-4975(00)01513-7.
- Results publication: PubMed 16474029Schussler O, Alifano M, Dermine H, Strano S, Casetta A, Sepulveda S, Chafik A, Coignard S, Rabbat A, Regnard JF. Postoperative pneumonia after major lung resection. Am J Respir Crit Care Med. 2006 May 15;173(10):1161-9. doi: 10.1164/rccm.200510-1556OC. Epub 2006 Feb 10.
- Individual participant dataSharing planned: No
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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.
Gregor J Kocher, MD principal investigator
Division of General Thoracic Surgery, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Function Decreased and Lung Diseases, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 15 Feb 2017. 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 Switzerland. 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?
Decrease in FEV1 (time frame: up to 6 days after surgery). 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 NCT03054675, which also lists 3 linked publications.
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 15 Feb 2017.