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Trial registered on ANZCTR


Registration number
ACTRN12613000931774
Ethics application status
Approved
Date submitted
11/08/2013
Date registered
23/08/2013
Date last updated
15/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the efficacy of digital versus traditional suction drainage system in the treatment of pneumothorax with air leak
Scientific title
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.
Secondary ID [1] 283000 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumothorax with air leak 289827 0
Condition category
Condition code
Surgery 290184 290184 0 0
Surgical techniques
Respiratory 290202 290202 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 287732 0
Treatment: Surgery
Intervention code [2] 287733 0
Treatment: Other
Comparator / control treatment
In group B with TSDS the chest tube drainage which was inserted to the pleural cavity was connected to the wall suction port with a constant negative pressure. The value of suction is regulated using a pipe in a glass bottle connected to the source of negative pressure. Negative pressure of -15 cm H20 was applied in the patients. AL is assessed by the staff who observe bubbling in the water column. In the TSDS it is difficult to obtain precise data when AL is stopped. Another disadvantage is that the patients are immobilized in bed throughout the procedure.
The moment of AL stoppage decided about the drainage duration.
Indications chest drainage discontinuation were as follows:
1) pleural fluid output not greater than 200 mL/day;
2) no AL detected within consecutive 6 h (stoppage of bubbling in the water column)
3) sufficient lung expansion evident on portable chest X-ray.
In case of small AL without lung collapse on chest X-ray within the last 12 h, TSDS was changed to passive drainage for 6 h, connecting the chest tube to water seal. If there was not AL observed and lung was expanded the drainage was removed.
Control group
Active

Outcomes
Primary outcome [1] 290214 0
In group A patients, mean duration of the drainage was 47.63+/-24.85. Mean drainage duration in group B patients was 84.93+/-36.58 h. The drainage duration was longer by 37,3 h in group B than in group A patients.
Comparison of median values with the use of Mann-Whitney (Wilcoxon) W-test confirmed a statistically significant shorter drainage duration when DDS was applied in the treatment [P-value= 0.000039].
Timepoint [1] 290214 0
At completion of drainage
Secondary outcome [1] 304122 0
Mean hospitalization time of group A patients was 5.1+/-1.09 days. Mean value of hospitalization of group B patients was 7.00+/-1.96 days. Hospitalization of group B patients appeared to be 1,87 day longer.
This observation was confirmed by the obtained high statistical significance with the use of Kruskal-Wallis Test [P-value< 0.0005].
Timepoint [1] 304122 0
Discharge from hospital
Secondary outcome [2] 304194 0
Aim: Assessment of the time needed to make a decision about surgery

If in both groups, the patients with AL which persisted over 18 h (12 h suction drainage + 6 h gravity drainage) and in whom chest radiographs showed no full expansion of the lung, were qualified for surgery.
Statistical methods:
Numerical variables between the two groups of patients were compared with the Student’s t-test [for normal distribution] and Mann-Whitney (Wilcoxon) W-test [for other than normal distribution]. Cathegorical data were analyzed by Chi2 independence test. Statgraphic Centurion XVI was applied for the analysis.
Eleven group A patients required surgical procedure. The patients were qualified for surgery 8.43+/-11.98h after drainage insertion. In group B 12 patients were qualified for the surgical treatment. The surgery was performed 23.6+/-35.07 h after drainage placement.
The decision about surgical procedure was made in patients treated with TSDS nearly 15 h later.
In the statistical analysis no difference was observed [P-value = 0.3208] in mean values because of noted no-normal distribution.
Timepoint [2] 304194 0
Time of decision about surgical procedure
Secondary outcome [3] 304195 0
Mean cost of hospitalization of group A patients was 1495.27+/-623.1€. Mean hospitalization cost of group B patients was 1925.17+/-792.38 €. Statistical analysis demonstrated that the use of DDS in the treatment of patients having pneumothorax with AL results in statistically significantly lower treatment costs as compared to TSDS [P-value = 0.02297].
Timepoint [3] 304195 0
Discharge from hospital
Secondary outcome [4] 304216 0
Aim: Evaluation of the intensity of air leak within 1 h after drainage insertion (comparison of groups A and B)

The patients qualified for the study, after drain insertion into the pleura, were initially connected to digital drainage for
1 h.
Quantitative determination of AL (recorded in computer keyboard in mL/min) was performed after 1h of the drainage. Then, the patients with no AL after 1h of the drainage or with borderline AL < 20 mL/min, were excluded from the study group.
If AL persisted at the level > 20 mL/min, the patients were qualified for further study.
Initial connection of all the patients to the digital drainage system for 1 h was necessary in order to determine objectively the output value of AL expressed in mL/min in both groups (A and B).
Statistical methods:
Numerical variables between the two groups of patients were compared with the Student’s t-test [for normal distribution] and Mann-Whitney (Wilcoxon) W-test [for other than normal distribution]. Cathegorical data were analyzed by Chi2 independence test. Statgraphic Centurion XVI was applied for the analysis.
Intensity of air leak
Group A: mean value of the AL 60 minutes after drainage insertion was 94+/- 65,27 mL/min; (median:67,5 mL/min). AL ranged from 20 mL/min (minimum) to 240 mL/min (maximum).
Group B: mean initial level of AL in patients treated with TSDS ( 60 minutes after drainage insertion) was 100,17+/- 74,17 mL/min; (median:70,0 mL/min). It ranged from 20 mL/min to 270 mL/min.
Statistical analysis demonstrated that the initial value
of AL did not affect the final outcome of the treatment
in the investigated groups
[P-value = 0.7337].
Timepoint [4] 304216 0
Evaluation of air leak intensity after 1 h of the drainage

Eligibility
Key inclusion criteria
Symptomatic Spontaneous Pneumothorax
The treatment using chest tube drainage
Air leak observed after insertion of the drain into the pleura
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-Symptomatic Spontaneous Pneumothorax
Pneumothorax treated conservatively or using simple aspiration.
Chest tube drainage without air leak

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
NONE
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
In the conditions of one center it is difficult to find a large number of patients with pneumothorax with AL during the treatment with the use suction drainage. We managed to gather 60 such patients and to achieve the objective of the study we divided them int 30 patients each group.
The following outcome variables were analyzed: drainage duration (hours); length of hospital stay, surgery delay (hours) and overall hospitalization costs (expressed in euro €).Numerical variables between the two groups of patients were compared with the Student’s t-test [for normal distribution], Mann-Whitney (Wilcoxon) W-test [for other than normal distribution] and the Kruskal-Wallis test to
investigate the influence of the type of drainage. Cathegorical data were analyzed by Chi2 independence test. Statgraphic Centurion XVI was applied
for the analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/08/2008
Actual
14/08/2008
Date of last participant enrolment
Anticipated
31/12/2012
Actual
17/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5289 0
Poland
State/province [1] 5289 0
Lodz

Funding & Sponsors
Funding source category [1] 287767 0
Hospital
Name [1] 287767 0
Department of Thoracic Surgery, General and Oncological Surgery, Medical University of Lodz
Country [1] 287767 0
Poland
Primary sponsor type
Hospital
Name
Department of Thoracic Surgery, General and Oncological Surgery, Medical University of Lodz
Address
90-549 Lodz, 113 Zeromskiego St.
Country
Poland
Secondary sponsor category [1] 286493 0
University
Name [1] 286493 0
Medical University of Lodz
Address [1] 286493 0
490-419 Lodz, Kosciuszki St.
Country [1] 286493 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289714 0
Bioethics Committee of the Medical University of Lodz
Ethics committee address [1] 289714 0
Ethics committee country [1] 289714 0
Poland
Date submitted for ethics approval [1] 289714 0
03/06/2008
Approval date [1] 289714 0
22/06/2008
Ethics approval number [1] 289714 0
RNN/799/08/KB

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42094 0
Prof Brocki Marian
Address 42094 0
Department of Thoracic Surgery, General and Oncological Surgery, Medical University of Lodz, 90-547 Lodz, 113 Zeromskiego St.
Country 42094 0
Poland
Phone 42094 0
(+48)42 6393521
Fax 42094 0
(+48) 42- 6333890
Email 42094 0
[email protected]
Contact person for public queries
Name 42095 0
Brocki Marian
Address 42095 0
Department of Thoracic Surgery, General and Oncological Surgery, Medical University of Lodz, 90-547 Lodz, 113 Zeromskiego St.
Country 42095 0
Poland
Phone 42095 0
(+48)42 6393521
Fax 42095 0
Email 42095 0
[email protected]
Contact person for scientific queries
Name 42096 0
Brocki Marian
Address 42096 0
Department of Thoracic Surgery, General and Oncological Surgery, Medical University of Lodz, 90-547 Lodz, 113 Zeromskiego St.
Country 42096 0
Poland
Phone 42096 0
(+48)42 6393521
Fax 42096 0
Email 42096 0
[email protected]

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