Perioperative Lung Function Monitoring After Anatomic Lung Resections

Completed

• Conditions: Lung Function Decreased; Surgery; Lung Diseases
• Interventions: Diagnostic Test: Spirometry

• Registration Number: NCT03054675
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

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 Timeline

• Study Start: 2013-06-01
• Primary Completion: 2016-06-30
• Study Completion: 2016-06-30
• Status Verified: 2017-02
• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-02-13
• Last Update Submitted: 2017-02-13
• Study First Posted: 2017-02-15
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 328

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Open (no pneumonia)	Spirometry	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.
Minimally invasive (no pneumonia)	Spirometry	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.
Pneumonia	Spirometry	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
No Pneumonia	Spirometry	Patients without pneumonia undergo spirometry before and on every second day after lung surgery

Primary Outcome Measures

Name	Time	Method
Decrease in FEV1	up to 6 days after surgery	Postoperative loss of FEV1 in percent of absolute preoperative levels

Trial Locations

Locations (1)

University Hospital Bern; 🇨🇭 Bern, Switzerland