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

August 4, 2010
May 5, 2013
July 2011
November 2012   (final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01177215 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
Not Provided
 
Investigation of an Adaptive Treatment Algorithm for Post-op Thoracic Patients to Reduce the Length of Drainage
Implementation of an Adaptive Algorithm to Improve Chest Tube Therapy in Patients With Pulmonary Leaks Following Thoracic Surgery

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Thoracic Surgery Patient

Pulmonary Fistula
Procedure: Thoracic Surgery
Wedge Resection Segmental Resection Lobectomy
Other Name: Thopaz Drainage Device
Digital chest tube
All patients will be treated with the digital chest tube device
Intervention: Procedure: Thoracic Surgery

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
39
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01177215
GE-ADAPTALGO-2010
Yes
Inez Cregan, Medela AG
Medela AG
Not Provided
Principal Investigator: Thorsten Walles, MD FETCS Schillerhoehe Hospital
Medela AG
May 2013

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