Perioperative Lung Function Monitoring After Anatomic Lung Resections

NCT ID: NCT03054675

Last Updated: 2017-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

328 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-01

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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Lung Function Decreased Lung Diseases Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Spirometry

Intervention Type DIAGNOSTIC_TEST

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

Spirometry

Intervention Type DIAGNOSTIC_TEST

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.

Spirometry

Intervention Type DIAGNOSTIC_TEST

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.

Spirometry

Intervention Type DIAGNOSTIC_TEST

Absolute FEV1 is measured in every patient using a handheld spirometer

Interventions

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Spirometry

Absolute FEV1 is measured in every patient using a handheld spirometer

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregor J Kocher, MD

Role: PRINCIPAL_INVESTIGATOR

Division of General Thoracic Surgery, University Hospital Bern

Locations

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University Hospital Bern

Bern, Canton of Bern, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 24884793 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11016337 (View on PubMed)

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.

Reference Type RESULT
PMID: 16474029 (View on PubMed)

Other Identifiers

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266/15

Identifier Type: -

Identifier Source: org_study_id

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