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NCT Number: NCT01467622

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

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.

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Key information

Conditions

Pulmonary Air Leak

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Evangelische Lungenklinik Berlin, Berlin, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chest tube removal

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Schillerhoehe Hospital

Other

Collaborators

  • Medela AG

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2011
First posted
Nov 9, 2011
Registry last updated
May 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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