CompletedPhase 2ACTRN12613000931774

Comparison of the efficacy of digital versus traditional suction drainage system in the treatment of pneumothorax with air leak

A Randomized, one-center, Phase 2 Study to Compare the efficacy of the treatment of patients with spontaneous pneumothorax (SP) with air leak (AL) using digital versus traditional suction drainage systems.


Sponsor

Department of Thoracic Surgery, General and Oncological Surgery, Medical University of Lodz

Enrollment

60 participants

Start Date

Aug 14, 2008

Study Type

Interventional

Conditions

Summary

Aim The aim of this study was to compare the efficacy of the treatment of patients with spontaneous pneumothorax (SP) with air leak (AL) using two different chest drainage systems. Methods Patients were randomized in two groups: Group A included 30 patients (23 males, 7 females, mean age 41,1+/-16,29 years, range 17-71 years) in which digital drainage system (DDS) was used, Group B with 30 patients (22 males and 8 females, mean age 40,3+/-15,74 years, range 18-72 years) in which traditional suction drainage system (TSDS) was applied. The following variables were evaluated: intensity of air leak, duration of the chest tube drainage, delay in surgery, length of stay, overall hospitalization costs. Results In group A the drains were removed, on the average, after 47,63 h, the hospitalization time was 5,10 days, the cost of hospitalization was 1495 Euro. In group B: the mean drainage duration was 84,93 h, hospitalization 6,97 days, hospitalization cost 1925 Euro. Conclusion The digital drainage system applied in the treatment of AL in patients with pneumothoraces reduced the duration of the drainage, the length of hospital stay and overall hospitalization costs.


Eligibility

Sex: Both males and females

Inclusion Criteria3

  • Symptomatic Spontaneous Pneumothorax
  • The treatment using chest tube drainage
  • Air leak observed after insertion of the drain into the pleura

Exclusion Criteria3

  • Non-Symptomatic Spontaneous Pneumothorax
  • Pneumothorax treated conservatively or using simple aspiration.
  • Chest tube drainage without air leak

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Interventions

Digital drainage system consists of electronic portable pump that supports a constant negative pressure. The pressure can be regulated to different values. A computer keyboard enables continuous digi

Digital drainage system consists of electronic portable pump that supports a constant negative pressure. The pressure can be regulated to different values. A computer keyboard enables continuous digital air leak (AL) recording. Digital drainage, owing to the analysis of quantitative data recorded in the form of electronic memory of the device, allows to determine precisely when the AL stoppage occurred. This gives the possibility of earlier decision of drainage removal or qualification for surgery. Improvement in the comfort of patients owing to maintained full mobility from the very beginning of the treatment, which can be also regarded as a form of physiotherapy accelerating expansion of the collapsed lung, should be listed among additional advantages associated with this system. Study groups Group A: digital drainage system (DDS) with electronic portable pump that supports a constant negative pressure which can be regulated from -15 cm H2O was applied in the patients. Group B: traditional suction drainage system (TSDS) connected to the wall suction port with a constant negative pressure which can be regulated from -15 cm H2O was used. AL was subjectively assessed by bubbling in the water-seal column. The duration of the drainage with the application of DDS was conditioned by obtaining AL. stoppage. The chest tube was considered ready for removal after all the following conditions were met: 1) no more than 200 mL/24 h of pleural effusion output; 2) an average AL flow 0 mL/min during the last 6 h; 3) sufficient lung expansion at the portable chest-X ray. In case of a limited AL (no more than 20 ml/min during the last 12 h) and sufficient lung expansion at the radiological control, suction Thopaz drainage system was switched to gravity mode corresponding to passive drainage with water seal. If AL stopped within 6 h of observation, the chest tube was finally removed


Locations(1)

Lodz, Poland

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ACTRN12613000931774