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Trial registered on ANZCTR


Registration number
ACTRN12612000108819
Ethics application status
Approved
Date submitted
14/01/2012
Date registered
23/01/2012
Date last updated
23/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
How to distinguish an active air leak from a pleural space effect by means of a digital chest drain system
Scientific title
Differences between active air leak and pleural space effect detected by means a digital chest drain system on patients submitted to lung resections and plural biopsies
Secondary ID [1] 279730 0
nil
Universal Trial Number (UTN)
U1111-1127-1857
Trial acronym
DBAALPSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prolonged pulmonary air leakage 285610 0
Condition category
Condition code
Respiratory 285769 285769 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In this observational study we aimed to recognize a pleural space effect, distinguishing it from an active air leak, by means of a digital chest drain system providing a continuous air flow and pleural pressures check. Since March 2010 to October 2011, we employed 144 digital drains for 125 patients undergone 138 thoracic surgical procedures. We observed: 18 active air leaks (12.5%), among which 4 prolonged (2.8%), all characterized by high differential pleural pressure, especially due to an increased mean expiratory pressure (>1 cmH2O) (p <0.0001), and significantly related to upper lobe resections (p: 0.00017), a chest tube removal time later than the fifth post-operative day (p <0.0001), an increasing pneumothorax after a one day provocative clamping (p <0.0001); three late air leaks (2.1%), all long lasting (p <0.0001), predicted by pressure curves divergency before the air flow appearance. Moreover, we reported 25 pleural space effects (17.4%), equally characterized by a high differential pleural pressure, but mainly due to a lower mean inspiratory pressure (<20 cmH2O) (p <0.0001), and especially related to surgical pleurodesis procedures (p: 0.0003) and wide lung resections (p: 0.0002); none of these patients had an increasing pneumothorax after provocative clamping. A digital chest drain system ensuring a continuous air flow and pleural pressures measurement could clearly identify a pleural space effect, avoiding the frequent misinterpretation with an active air leak and allowing to safely remove a chest tube at the right time.
Intervention code [1] 284029 0
Not applicable
Comparator / control treatment
No treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286288 0
To recognize a pleural space effect, distinguishing it from an active air leak, by means of a digital chest drain system: a pleural space effect is characterized by high pleural differential pressures and low trans-pleural air flows, while an active air leak is always characterized by high trans-pleural air flows. A digital chest drain system can detect both air flows and differential pleural pressures by means two MEMS (micro electronic mechanicakl systems) sensors, one for measuring flow and another for measuring pressures
Timepoint [1] 286288 0
Since March 2010 to October 2011
Secondary outcome [1] 295533 0
Nil
Timepoint [1] 295533 0
Nil

Eligibility
Key inclusion criteria
Patients submitted to thoracic surgery interventions
Minimum age
18 Years
Maximum age
88 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe lung emphysema - re-do-surgery - no touch lung surgery

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4052 0
Italy
State/province [1] 4052 0

Funding & Sponsors
Funding source category [1] 284511 0
Hospital
Name [1] 284511 0
I.R.C.C.S. - C.R.O.B. Basilicata Regional Cancer Institute
Address [1] 284511 0
Via Padre Pio, 1 - 85028 - Rionero in Vulture, Potenza, Italy
Country [1] 284511 0
Italy
Primary sponsor type
Hospital
Name
I.R.C.C.S. - C.R.O.B. Basilicata Regional Cancer Institute
Address
Via Padre Pio, 1 - Rionero in Vulture (PZ)
Country
Italy
Secondary sponsor category [1] 283441 0
None
Name [1] 283441 0
Address [1] 283441 0
Country [1] 283441 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286495 0
Comitato Etico I.R.C.C.S. - C.R.O.B.
Ethics committee address [1] 286495 0
Via Padre Pio, 1 - Rionero in Vulture - 85028 - Potenza, Italy
Ethics committee country [1] 286495 0
Italy
Date submitted for ethics approval [1] 286495 0
01/01/2010
Approval date [1] 286495 0
02/02/2010
Ethics approval number [1] 286495 0
Nil

Summary
Brief summary
Bachground: In this prospective study we aimed to recognize a pleural space effect, distinguishing it from an active air leak, by means of a digital chest drain system providing a continuous air flow and pleural pressures check. Methods: Since March 2010 to October 2011, we employed 144 digital drains for 125 patients undergone 138 thoracic surgical procedures. Results: We observed: 18 active air leaks (12.5%), among which 4 prolonged (2.8%), all characterized by high differential pleural pressure, especially due to an increased mean expiratory pressure (>1 cmH2O) (p <0.0001), and significantly related to upper lobe resections (p: 0.00017), a chest tube removal time later than the fifth post-operative day (p <0.0001), an increasing pneumothorax after a one day provocative clamping (p <0.0001); three late air leaks (2.1%), all long lasting (p <0.0001), predicted by pressure curves divergency before the air flow appearance. Moreover, we reported 25 pleural space effects (17.4%), equally characterized by a high differential pleural pressure, but mainly due to a lower mean inspiratory pressure (<20 cmH2O) (p <0.0001), and especially related to surgical pleurodesis procedures (p: 0.0003) and wide lung resections (p: 0.0002); none of these patients had an increasing pneumothorax after provocative clamping. Conclusions: A digital chest drain system ensuring a continuous air flow and pleural pressures measurement could clearly identify a pleural space effect, avoiding the frequent misinterpretation with an active air leak and allowing to safely remove a chest tube at the right time.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 33633 0
Address 33633 0
Country 33633 0
Phone 33633 0
Fax 33633 0
Email 33633 0
Contact person for public queries
Name 16880 0
Rita Daniela Marasco
Address 16880 0
Via Grecia, 21/A, 71122, Foggia, Italy
Country 16880 0
Italy
Phone 16880 0
+39.0881.633303
Fax 16880 0
+39.0972.726214
Email 16880 0
d.marasco@inwind.it
Contact person for scientific queries
Name 7808 0
Rita Daniela Marasco
Address 7808 0
Via Grecia, 21/A, 71122, Foggia, Italy
Country 7808 0
Italy
Phone 7808 0
+39.320.6555275
Fax 7808 0
+39.0972.726214
Email 7808 0
d.marasco@inwind.it

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary