Perioperative Lung Function Monitoring After Anatomic Lung Resections (PLF)

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.

Study Overview

• Status: Completed
• Conditions: Lung Diseases; Surgery; Lung Function Decreased
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 328

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • University Hospital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients undergoing an anatomical lung resection at our institution

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pneumonia; Patients suffering from postoperative pneumonia including all three of the following: Clinical signs of a pulmonary infection (i.e. fever ≥ 38°C combined with productive cough and/or dyspnea); A new rise of inflammatory markers (i.e. WBC count ≥ 10.5 x 109 and elevated CRP); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in FEV1	Postoperative loss of FEV1 in percent of absolute preoperative levels	up to 6 days after surgery

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Principal Investigator: Gregor J Kocher, MD, Division of General Thoracic Surgery, University Hospital Bern

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2013
• Primary Completion (ACTUAL): June 30, 2016
• Study Completion (ACTUAL): June 30, 2016

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: February 13, 2017
• First Posted (ACTUAL): February 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2017
• Last Update Submitted That Met QC Criteria: February 13, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: lung function; Thoracotomy; VATS; lung resection
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: 266/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No