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Trial registered on ANZCTR


Registration number
ACTRN12610000384055
Ethics application status
Not yet submitted
Date submitted
30/04/2010
Date registered
13/05/2010
Date last updated
13/05/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Incidence of pneumothorax post chest drain removal - a randomised control trial comparing two removal techniques
Scientific title
A randomised control trial on rate of pneumothorax between removal of chest drains in maximal inspiration and during a Valsalva manoeuvre
Secondary ID [1] 251671 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumothorax post chest drain removal 257268 0
Condition category
Condition code
Respiratory 257416 257416 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who have had chest drains inserted for various indications including thoracic surgery, spontaneous pneumothoraces or following drainage of pleural effusions and who are ready to undergo drain removal will be included in the study. The drain will be removed during a Valsalva manoeuvre, performed in forced expiration against a closed airway (by instructing the patient to put their thumb in their mouth and blow as if blowing a whistle). The procedure takes approximately 5 seconds and is a one-off event.
Intervention code [1] 256387 0
Other interventions
Comparator / control treatment
Similar to the intervention group, except that the removal of the chest drain is during a maximal inspiration.
Control group
Active

Outcomes
Primary outcome [1] 258332 0
The primary outcome measure is the presence (yes) or absence (no) of a pneumothorax, to be determined by the treating physician.
Timepoint [1] 258332 0
4 hours and 24 hours after removal of chest drain.
Secondary outcome [1] 264051 0
Maximum distance between the chest wall and the pleural surface of the lung (0-X cm), to be determined by the treating physician.
Timepoint [1] 264051 0
4 hours and 24 hours after removal of chest drain.
Secondary outcome [2] 264052 0
Degrees of difficulty in the performance of the two breathing holding techniques being studied; this will be recorded as a simple 4 variable score of no difficulty, slight difficulty, moderate difficulty and severe difficulty as rated by the participant undergoing chest drain removal.
Timepoint [2] 264052 0
At time of chest drain removal

Eligibility
Key inclusion criteria
1. Patients who have a single intercostal chest drain in situ and which the treating clinician has determined requires removal.
2. Willingness to give written informed consent and willingness to participate in and comply with the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Patients who have any radiological evidence of a residual pneumothorax prior to chest drain removal.
2.Patients who have more than 200mls of residual pleural fluid prior to chest drain removal as estimated on plain chest radiograph.
3.Patients who have had an air leak into the underwater seal within 24 hours prior to chest drain removal.
4.Patients with resting hypoxaemia (defined as a partial pressure of oxygen - PaO2 - of less than 55mmHg or saturation - SaO2 - of less than 90% on room air prior to the removal of the chest drain).
5.Patients who have undergone a pleurodesis procedure.
6.Patients who have more than one chest drain in situ at the time when one drain is to be removed. This applies to bilateral drains in patients who have undergone bilateral lung or heart-lung transplantation as these patients have a continuous communication between right and left hemithoraces; however once there is only one remaining drain for removal these patients would then become eligible for inclusion in the study.
7.Patients who are unable to clearly understand or comply with the nurse’s instructions with regard to the technique of breath holding during the removal of the chest drain.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consecutive patients who have had chest drains inserted for various indications including thoracic surgery, spontaneous pneumothoraces or following drainage of pleural effusions and who are ready to undergo drain removal will be assessed prospectively for suitability for inclusion in the study. The decision to remove the chest drain will be made exclusively by the attending clinicians and prior to and independent of any consideration as to the patient’s suitability for inclusion in the study.
The attending physician or registrar will explain the purpose of the study and discuss possible risks with the patient. In addition each patient will be provided with an information brochure. Consent will be entirely voluntary. The patient will be reassured that non-participation in the study will in no way affect their ongoing medical management. Written, informed consent will be obtained. Patients who do not have the capacity to provide written informed consent to participate will be excluded, as it is assumed they will not have the capacity to follow commands required to perform the techniques for chest drain removal.
The participant will be enrolled into the study after the informed consent process has been completed and the participant has met all inclusion criteria and none of the exclusion criteria. The participant will receive a study enrolment number and this will be documented in the participant’s medical record and on all study documents.
The participant will be randomised in a concealed manner on the day that the decision is made to remove the chest drain and after they have met the randomisation criteria. At this point the participant will be randomised to study procedure A or Study procedure B.
Allocation will be concealed by using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table from a statistics book.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256889 0
Self funded/Unfunded
Name [1] 256889 0
Unfunded
Country [1] 256889 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
Victoria Street
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 256163 0
None
Name [1] 256163 0
Address [1] 256163 0
Country [1] 256163 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258902 0
Ethics committee address [1] 258902 0
Ethics committee country [1] 258902 0
Date submitted for ethics approval [1] 258902 0
10/03/2010
Approval date [1] 258902 0
Ethics approval number [1] 258902 0

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

Contacts
Principal investigator
Name 31109 0
Address 31109 0
Country 31109 0
Phone 31109 0
Fax 31109 0
Email 31109 0
Contact person for public queries
Name 14356 0
Amy Hollingworth
Address 14356 0
St Vincent's Hospital
Victoria Street
Darlinghurst NSW 2010
Country 14356 0
Australia
Phone 14356 0
+612 8382 1111
Fax 14356 0
Email 14356 0
amyhollingworth@yahoo.com.au
Contact person for scientific queries
Name 5284 0
Amy Hollingworth
Address 5284 0
St Vincent's Hospital
Victoria Street
Darlinghurst NSW 2010
Country 5284 0
Australia
Phone 5284 0
+612 8382 1111
Fax 5284 0
Email 5284 0
amyhollingworth@yahoo.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.