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Perioperative Lung Function Monitoring After Anatomic Lung Resections (PLF)

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ClinicalTrials.gov Identifier: NCT03054675
Recruitment Status : Completed
First Posted : February 15, 2017
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief 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.

Condition or disease Intervention/treatment
Lung Function Decreased Lung Diseases Surgery Diagnostic Test: Spirometry

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.

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Study Type : Observational
Actual Enrollment : 328 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Perioperative Lung Function Monitoring After Anatomic Lung Resections
Actual Study Start Date : June 1, 2013
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : June 30, 2016

Group/Cohort Intervention/treatment
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
Diagnostic Test: 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
Diagnostic Test: 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.

Diagnostic Test: 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.

Diagnostic Test: Spirometry
Absolute FEV1 is measured in every patient using a handheld spirometer




Primary Outcome Measures :
  1. Decrease in FEV1 [ Time Frame: up to 6 days after surgery ]
    Postoperative loss of FEV1 in percent of absolute preoperative levels



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients undergoing an anatomical lung resection at our institution
Criteria

Inclusion Criteria:

  • Patients undergoing anatomical lung resection
  • Written informed consent

Exclusion Criteria:

  • Underage patients
  • Extended resections including resection of chest wall or diaphragm
  • Bronchoplastic resections

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054675


Locations
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Switzerland
University Hospital Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Gregor J Kocher, MD Division of General Thoracic Surgery, University Hospital Bern
Publications of Results:
Other Publications:
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03054675    
Other Study ID Numbers: 266/15
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
lung resection
lung function
VATS
Thoracotomy
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases