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

May 6, 2013 updated by: Thorsten Walles, Schillerhoehe Hospital

Prospective, Non Randomized Investigator Initiated Multi-centre Trial on the Effects of Local Treatment Protocols on the Duration of Chest Tube Therapy Following Thoracic Surgery in Germany

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13125
        • Evangelische Lungenklinik Berlin
      • Bremen, Germany, 28325
        • Klinikum Bremen-Ost gGmbH
      • Gerlingen, Germany, 70839
        • Klinik Schillerhoehe
      • Koblenz, Germany, 56073
        • Katholisches Klinikum Koblenz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients undergoing pulmonary resection at one of the four participating thoracic surgery specialist units

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study population
Patients undergoing elective pulmonary wedge resection, anatomic segmentectomy, or lobectomy.
Procedure: Chest tube removal
Chest tube removal on the basis of local recommendations for postoperative chest tube management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
chest tube therapy duration
Time Frame: participants are followed for the duration of hospital stay, an expected average of 5 days
number of days following thoracic surgery until chest tube was removed
participants are followed for the duration of hospital stay, an expected average of 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presence of pulmonary air leak
Time Frame: participants are followed for the duration of hospital stay, an expected average of 4 days
number of days the Medela Thopaz device detected a pulmonary air leak following thoracic surgery
participants are followed for the duration of hospital stay, an expected average of 4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schillerhoehe Hospital

Collaborators

Medela AG

Investigators

  • Principal Investigator: Thorsten Walles, MD, Schillerhoehe Hospital
  • Study Director: Albert Linder, MD, Klinikum Bremen-Ost gGmbH
  • Study Chair: Josef Wolf, Medela GmbH & Co. Handels KG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

October 30, 2011

First Submitted That Met QC Criteria

November 4, 2011

First Posted (Estimate)

November 9, 2011

Study Record Updates

Last Update Posted (Estimate)

May 7, 2013

Last Update Submitted That Met QC Criteria

May 6, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KSH-TCH-IIT-2009-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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