Perioperative Lung Function Monitoring After Anatomic Lung Resections

Surgery Clinical Trial

— PLF  

Official title:

Perioperative Lung Function Monitoring After Anatomic Lung Resections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03054675
• Other study ID #: 266/15
• Status: Completed
• Phase: N/A
• First received: February 13, 2017
• Last updated: February 13, 2017
• Start date: June 1, 2013
• Est. completion date: June 30, 2016

Study information

• Verified date: February 2017
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: June 30, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Lung Function Decreased
• Surgery

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in FEV1	Postoperative loss of FEV1 in percent of absolute preoperative levels	up to 6 days after surgery