NCT03054675

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
328

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
Last Updated

February 15, 2017

Status Verified

February 1, 2017

Enrollment Period

3.1 years

First QC Date

February 13, 2017

Last Update Submit

February 13, 2017

Conditions

Lung Function DecreasedLung DiseasesSurgery

Keywords

lung resectionlung functionVATSThoracotomy

Outcome Measures

Primary Outcomes (1)

  • Decrease in FEV1

    Postoperative loss of FEV1 in percent of absolute preoperative levels

    up to 6 days after surgery

Study Arms (4)

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

No Pneumonia

Patients without pneumonia undergo spirometry before and on every second day after lung surgery

Diagnostic Test: Spirometry

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

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

Interventions

SpirometryDIAGNOSTIC_TEST

Absolute FEV1 is measured in every patient using a handheld spirometer

Minimally invasive (no pneumonia)No PneumoniaOpen (no pneumonia)Pneumonia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients undergoing an anatomical lung resection at our institution

You may qualify if:

  • Patients undergoing anatomical lung resection
  • Written informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bern

Bern, Canton of Bern, 3010, Switzerland

Location

Related 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.

    PMID: 24884793BACKGROUND

  • 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.

    PMID: 11016337BACKGROUND

  • 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.

    PMID: 16474029RESULT

MeSH Terms

Conditions

Respiratory InsufficiencyLung Diseases

Interventions

Spirometry

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Gregor J Kocher, MD

    Division of General Thoracic Surgery, University Hospital Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 15, 2017

Study Start

June 1, 2013

Primary Completion

June 30, 2016

Study Completion

June 30, 2016

Last Updated

February 15, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)