Investigation of an Adaptive Treatment Algorithm for Post-op Thoracic Patients to Reduce the Length of Drainage

NCT ID: NCT01177215

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

TERMINATED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-11-30

Brief Summary

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The purpose of this study is to reduce the length of drainage using a treatment protocol to control the manipulation of the applied vacuum to the pleural cavity.

Detailed Description

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In this prospective study, a treatment algorithm is tested in a subgroup of patients with postoperative pulmo-pleural fistula. The primary aim is to reduce the duration of pulmo-pleural fistulation. Secondary aim is to reduce the duration of chest tube therapy.

Conditions

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Pulmonary Fistula

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Digital chest tube

All patients will be treated with the digital chest tube device

Thoracic Surgery

Intervention Type PROCEDURE

Wedge Resection Segmental Resection Lobectomy

Interventions

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Thoracic Surgery

Wedge Resection Segmental Resection Lobectomy

Intervention Type PROCEDURE

Other Intervention Names

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Thopaz Drainage Device

Eligibility Criteria

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Inclusion Criteria

* Patients with a post operative air leak after 16 to 24 hours bigger than 50ml/min.

Exclusion Criteria

* Patients with an empyema
* Patients with a spontaneous pneumothorax
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medela AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Inez Cregan

Study Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thorsten Walles, MD FETCS

Role: PRINCIPAL_INVESTIGATOR

Schillerhoehe Hospital

Locations

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Klinikum Bremen-Ost

Bremen, City state Bremen, Germany

Site Status

Klinik Schillerhöhe

Gerlingen, Gerlingen, Germany

Site Status

Universitätsklinik Freiburg

Freiburg im Breisgau, , Germany

Site Status

Krankenhaus Großhansdorf

Großhansdorf, , Germany

Site Status

Countries

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Germany

References

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Alex J, Ansari J, Bahalkar P, Agarwala S, Rehman MU, Saleh A, Cowen ME. Comparison of the immediate postoperative outcome of using the conventional two drains versus a single drain after lobectomy. Ann Thorac Surg. 2003 Oct;76(4):1046-9. doi: 10.1016/s0003-4975(03)00884-1.

Reference Type BACKGROUND
PMID: 14529982 (View on PubMed)

Baumann MH. What size chest tube? What drainage system is ideal? And other chest tube management questions. Curr Opin Pulm Med. 2003 Jul;9(4):276-81. doi: 10.1097/00063198-200307000-00006.

Reference Type BACKGROUND
PMID: 12806240 (View on PubMed)

Brunelli A, Sabbatini A, Xiume' F, Refai MA, Salati M, Marasco R. Alternate suction reduces prolonged air leak after pulmonary lobectomy: a randomized comparison versus water seal. Ann Thorac Surg. 2005 Sep;80(3):1052-5. doi: 10.1016/j.athoracsur.2005.03.073.

Reference Type BACKGROUND
PMID: 16122484 (View on PubMed)

Cerfolio RJ, Bryant AS. The benefits of continuous and digital air leak assessment after elective pulmonary resection: a prospective study. Ann Thorac Surg. 2008 Aug;86(2):396-401. doi: 10.1016/j.athoracsur.2008.04.016.

Reference Type BACKGROUND
PMID: 18640304 (View on PubMed)

Varela G, Jimenez MF, Novoa NM, Aranda JL. Postoperative chest tube management: measuring air leak using an electronic device decreases variability in the clinical practice. Eur J Cardiothorac Surg. 2009 Jan;35(1):28-31. doi: 10.1016/j.ejcts.2008.09.005. Epub 2008 Oct 9.

Reference Type BACKGROUND
PMID: 18848460 (View on PubMed)

Other Identifiers

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GE-ADAPTALGO-2010

Identifier Type: -

Identifier Source: org_study_id

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