Perioperative Lung Function Monitoring After Anatomic Lung Resections
NCT ID: NCT03054675
Last Updated: 2017-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
328 participants
OBSERVATIONAL
2013-06-01
2016-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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
Spirometry
Absolute FEV1 is measured in every patient using a handheld spirometer
No Pneumonia
Patients without pneumonia undergo spirometry before and on every second day after lung surgery
Spirometry
Absolute FEV1 is measured in every patient using a handheld spirometer
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.
Spirometry
Absolute FEV1 is measured in every patient using a handheld spirometer
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.
Spirometry
Absolute FEV1 is measured in every patient using a handheld spirometer
Interventions
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Spirometry
Absolute FEV1 is measured in every patient using a handheld spirometer
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
Exclusion Criteria
* Extended resections including resection of chest wall or diaphragm
* Bronchoplastic resections
18 Years
ALL
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Gregor J Kocher, MD
Role: PRINCIPAL_INVESTIGATOR
Division of General Thoracic Surgery, University Hospital Bern
Locations
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University Hospital Bern
Bern, Canton of Bern, Switzerland
Countries
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References
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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.
Nakata 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.
Schussler 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.
Other Identifiers
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266/15
Identifier Type: -
Identifier Source: org_study_id
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