Effects of Local Protocols on Duration of Chest Tube Therapy Following Thoracic Surgery

NCT ID: NCT01467622

Last Updated: 2013-05-07

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

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-10-31

Brief Summary

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The effect of local chest-tube management protocols on the duration of chest-tube therapy following thoracic surgery was analyzed in four German specialized Thoracic Surgery Units. The primary study objective was the duration of chest tube therapy in postoperative patients.

Detailed Description

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The management of chest tubes is probably one of the most critical aspects in patient care in thoracic surgery and defines the required length of postoperative hospital stay in the majority of patients. So far, no generally accepted recommendations exist for postoperative chest tube management to streamline the postoperative stay. Instead, decision making in most thoracic surgery units is based on team preferences and individual training rather than scientific data. Therefore, digital pleural drainage systems represent a useful tool to standardize existing intradepartmental protocols for chest tube management. However, for the development of generally accepted protocol-recommendations, the diverging interdepartmental treatment protocols have to be analyzed and compared for superiority. In this IIT, the effect of different chest tube management protocols on chest tube duration is analyzed in four German Thoracic Surgery units.

Conditions

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Pulmonary Air Leak

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study population

Patients undergoing elective pulmonary wedge resection, anatomic segmentectomy, or lobectomy.

Chest tube removal

Intervention Type PROCEDURE

Chest tube removal on the basis of local recommendations for postoperative chest tube management

Interventions

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Chest tube removal

Chest tube removal on the basis of local recommendations for postoperative chest tube management

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age 18-85
* following pulmonary wedge resection, anatomic segmentectomy, or lobectomy

Exclusion Criteria

* surgery for spontaneous pneumothorax (primary and secondary)
* surgery for pleural empyema
* present medication with corticoids, immunosuppressive drugs or platelet aggregation inhibitors other than Aspirin
* history of chemotherapy, radiotherapy of the chest, or previous ipsilateral thoracic surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medela AG

INDUSTRY

Sponsor Role collaborator

Schillerhoehe Hospital

OTHER

Sponsor Role lead

Responsible Party

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Thorsten Walles

Prinicpal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Albert Linder, MD

Role: STUDY_DIRECTOR

Klinikum Bremen-Ost gGmbH

Thorsten Walles, MD

Role: PRINCIPAL_INVESTIGATOR

Schillerhoehe Hospital

Josef Wolf

Role: STUDY_CHAIR

Medela GmbH & Co. Handels KG

Locations

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Evangelische Lungenklinik Berlin

Berlin, , Germany

Site Status

Klinikum Bremen-Ost gGmbH

Bremen, , Germany

Site Status

Klinik Schillerhoehe

Gerlingen, , Germany

Site Status

Katholisches Klinikum Koblenz

Koblenz, , Germany

Site Status

Countries

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Germany

References

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Linder A, Ertner C, Steger V, Messerschmidt A, Merk J, Cregan I, Timm J, Walles T. Postoperative chest tube management: snapshot of German diversity. Interact Cardiovasc Thorac Surg. 2012 Oct;15(4):622-6. doi: 10.1093/icvts/ivs270. Epub 2012 Jun 29.

Reference Type RESULT
PMID: 22753431 (View on PubMed)

Other Identifiers

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KSH-TCH-IIT-2009-1

Identifier Type: -

Identifier Source: org_study_id

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