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

This study has been terminated.

(Interim analysis showed that the tested protocol did not improve treatment)

Sponsor:

Information provided by (Responsible Party):

Inez Cregan, Medela AG

ClinicalTrials.gov Identifier:

NCT01177215

First received: August 4, 2010

Last updated: May 5, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 4, 2010

Last Updated Date

May 5, 2013

Start Date ^ICMJE

July 2011

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Duration of pulmo-pleural fistulation [ Time Frame: July 2011 - March 2012 ] [ Designated as safety issue: No ]

The duration of a postoperative pulmo-pleural fistula is monitored.

Original Primary Outcome Measures ^ICMJE

Drainage Time Reduction [ Time Frame: June - December 2010 ] [ Designated as safety issue: No ]

It shall be investigated if the manipulation of the vacuum applied to the pleural cavity can reduce the total amount of air leak and the length of drainage.

Change History

Complete list of historical versions of study NCT01177215 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Duration of Chest tube therapy [ Time Frame: July 2011 - March 2012 ] [ Designated as safety issue: No ]
Duration of postoperative chest tube therapy is monitored.
Applicability of a diagnostic "Leakage Scale" [ Time Frame: July 2011 - March 2012 ] [ Designated as safety issue: No ]
Applicability of a generated scale that categorizes the pulmonary air leak is tested.

Original Secondary Outcome Measures ^ICMJE

Calculation of Leakage Size [ Time Frame: June - December 2010 ] [ Designated as safety issue: No ]
It shall be investigated if the amount of air leak could be calculated using vacuum and air flow data during the treatment of the patient.
Leakage Scale [ Time Frame: June - December 2010 ] [ Designated as safety issue: No ]
A simple scale from 0 to 5 shall be developed to describe the amount of air leak quantitatively.
Treatment Protocol [ Time Frame: June - December 2010 ] [ Designated as safety issue: No ]
A treatment protocol shall be developed which describes medical decisions based on a quantitative simple scale.
Drain Pulling Criteria [ Time Frame: June - December 2010 ] [ Designated as safety issue: No ]
A standartized criteria to pull the drain shall be developed.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Implementation of an Adaptive Algorithm to Improve Chest Tube Therapy in Patients With Pulmonary Leaks Following Thoracic Surgery

Brief Summary

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

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Thoracic Surgery Patient

Condition ^ICMJE

Pulmonary Fistula

Intervention ^ICMJE

Procedure: Thoracic Surgery

Wedge Resection Segmental Resection Lobectomy

Other Name: Thopaz Drainage Device

Study Group/Cohort (s)

Digital chest tube

All patients will be treated with the digital chest tube device

Intervention: Procedure: Thoracic Surgery

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

November 2012

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01177215

Other Study ID Numbers ^ICMJE

GE-ADAPTALGO-2010

Has Data Monitoring Committee

Yes

Responsible Party

Inez Cregan, Medela AG

Study Sponsor ^ICMJE

Medela AG

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Thorsten Walles, MD FETCS

Schillerhoehe Hospital

Information Provided By

Medela AG

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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