Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001146583
Ethics application status
Approved
Date submitted
6/10/2015
Date registered
28/10/2015
Date last updated
30/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
An assessment of the flow rate of Baxter balloon pumps in a hyperbaric chamber
Scientific title
An assessment of the flow rate of the Baxter Elastomeric Large Volume (LV 10) Infusor pump under hyperbaric conditions using current hyperbaric patients and staff and marine biology students
Secondary ID [1] 287608 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
medication administration 296411 0
Condition category
Condition code
Other 296679 296679 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The primary outcome of this study is to determine the effect of hyperbaric pressure on the flow rate of the Baxter elastomeric LV 10 pumps. This will be done by placing elastomeric pumps in the hyperbaric chamber at three different pressures and comparing the flow rates to those obtained by elastomeric pumps not pressurized. Pump weight will be used as a surrogate for flow rate. At no time will any solution be administered into any participant. The solution will be collected in a specimen container held next to the participants arm.
Participants will be allocated to one of the 4 pressure groups. All pressurizations will be in a hyperbaric chamber, no participant will be underwater. The 0 kPa group will have the pump attached to their arm for 2 hours. The other 3 pressure groups will be of the duration of their respective treatment table, T10 (101kPa) 90 minutes , T14. (140 kPa) 110 minutes and T18 90 minutes (180 kPa). Participants may be used more than once. All dives will be no-decompression dives (ie decompression stops on ascent are not required to off gas absorbed nitrogen during compression to prevent decompression sickness (the bends)) and no participant will be compressed on two consecutive days. A certified hyperbaric technician will compress the chamber and monitor that all treatment pressures are adhered to by the current computerized chamber system.

This study will test one null hypothesis:

Hypothesis 1: There is no difference in the flow rate of elastomeric pumps at sea level (0kPa) and any of the three common hyperbaric treatment pressures (101 kPa, 140 kPa and 180 kPa).
Intervention code [1] 293002 0
Treatment: Devices
Comparator / control treatment
The primary outcome of this study is to determine the effect of hyperbaric pressure on the flow rate of the Baxter elastomeric LV 10 pumps. This will be done by placing elastomeric pumps in the hyperbaric chamber at three different pressures and comparing the flow rates to those obtained by elastomeric pumps not pressurized, control 0 kPa. Pump weight will be used as a surrogate for flow rate.
Control group
Dose comparison

Outcomes
Primary outcome [1] 296284 0
The primary outcome of this study is to determine the effect of hyperbaric pressure on the flow rate of the Baxter elastomeric LV 10 pumps. In a pilot study it was verified that the weight of the delivered solution equaled the infusion rate that is gram=milliliters, therefore weight will be used as a surrogate marker of flow rate. The pumps will be weighed using a scale, rated for 1 kilogram with 2 decimal points, prior to compression and at the end of compression to determine the amount of solution delivered and therefore flow rate.
Timepoint [1] 296284 0
Pumps will be tested at 0 (sea level) and at 101, 140 and 180 kilopascals (kPa). Separate pumps will be tested at the commencement of the infusion (0 to 2 hours) and at the last 2 hours (19 to 21 hours post commencement) to replicate the clinically significant time the patient would be in the hyperbaric chamber.
Secondary outcome [1] 318084 0
There is no secondary outcome.
Timepoint [1] 318084 0
There is no secondary outcome.

Eligibility
Key inclusion criteria
Hyperbaric trained staff working in the hyperbaric medicine unit or JCU marine biology students with a current dive medical and therefore fit to dive and be compressed in the hyperbaric chamber.
Current hyperbaric patients being treated at The Townsville Hospital in the hyperbaric medicine unit and already scheduled for treatment at one of the allocated pressures.
Age of 18 years or older
General public volunteers may enrol in the control pressure group but will not be compressed.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People unable to give informed consent
Age less than 18 years old
Pregnant-deemed not fit to dive
Allergy to antibiotic used
Allergy to adhesive dressing used

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



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The primary outcome of this study is to determine the effect of hyperbaric pressure on the flow rate of the Baxter elastomeric LV 10 pumps. In a pilot study it was verified that the weight of the delivered solution equaled the infusion rate that is gram equals milliliters, therefore weight will be used as a surrogate marker of flow rate. The mean amount of solution delivered across the different compression and time points will be analyzed using two-way analysis of variance (ANOVA).

The pump specifications state that the nominal flow rate will be 10 ml/hr plus or minus 10 percent using 5 percent dextrose as a diluent solution at 31.1 degrees Celsius. The flow rate may be 1o percent faster than the labelled rate (i.e, 11 ml/hr) when normal saline (NS) is used. All the antibiotics at The Townsville Hospital are diluted using NS; therefore a flow rate of 11 ml/hr will be used. A 10 percent (1.0 to 1.1 ml) under or over administration rate is considered clinically acceptable; a flow rate error of 20 percent more or less than recommended could be clinically significant. Therefore a flow rate of less than 9 or greater than 13 ml/hr will be considered significant.

The sample size calculation is based on 4 levels of effect for pressurization (0 kPa, 101 kPa, 140 kPa, 180 kPa) and 2 levels of effect for time (0 to 2 hrs and 19-21 hours), a known variability in the pump delivery rate of plus or minus 10 percent (or 1 ml), and a 2 ml threshold for significance (i.e., an effect size of 2.0). We estimate a sample size of 5 pumps at each compression depth for each time point (total equals 40) will provide a greater than 90 percent power (with an alpha equal to 0.05) to detect a 2.0 ml difference in delivered volume across the different compressions and time points.

We will use separate pumps for each test. That is, we won't use the same pump for 0 to 2 hr at 0 kPa and then waste the remainder to use it again at 19 to 21 hr. This is to avoid compounding the intrinsic error in a single pump.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/05/2015
Date of last participant enrolment
Anticipated
29/02/2016
Actual
4/01/2016
Date of last data collection
Anticipated
Actual
4/01/2016
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4433 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 10638 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 292175 0
Commercial sector/Industry
Name [1] 292175 0
Baxter Healthcare Corporation
Country [1] 292175 0
United States of America
Primary sponsor type
University
Name
James Cook University
Address
James Cook University
1 James Cook Drive
Townsville, QLD 4811, Australia
Country
Australia
Secondary sponsor category [1] 290848 0
Hospital
Name [1] 290848 0
The Townsville Hospital
Address [1] 290848 0
100 Angus Smith Dr
Douglas, QLD
4814
Country [1] 290848 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293648 0
Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 293648 0
Research Support Unit
James Cook University Clinical School
The Townsville Hospital
100 Angus Smith Dr
Douglas QLD 4814
Ethics committee country [1] 293648 0
Australia
Date submitted for ethics approval [1] 293648 0
18/01/2015
Approval date [1] 293648 0
25/02/2015
Ethics approval number [1] 293648 0
HREC/15/QTHS/7

Summary
Brief summary
Elastomeric pumps are balloons filled with antibiotics. As they deflate they deliver the medication to the patient at a constant rate. Patients that require long term antibiotics, such as as for infections in the bone, often use these pumps. These patients may also require treatment in the hyperbaric chamber for their infection. This study will compare the flow rate of the elastomeric pump in the hyperbaric chamber with its flow rate outside the hyperbaric chamber. If the pump flows at the same rate in the hyperbaric chamber there will be no need for disconnecting the pump before hyperbaric treatment. This will improve patient care by reducing the risk of infection and ensure appropriate antibiotic dose administration.
Trial website
Trial related presentations / publications
Submitted to Diving and Hyperbaric Medicine, responded to reviewers comments, should be published soon
Public notes

Contacts
Principal investigator
Name 60822 0
Dr Denise Faye Blake
Address 60822 0
IMB 23
Emergency Department
The Townsville Hospital
100 Angus Smith Drive
Douglas, QLD
4814
Country 60822 0
Australia
Phone 60822 0
61 7 4433 1111
Fax 60822 0
Email 60822 0
[email protected]
Contact person for public queries
Name 60823 0
Dr Denise Faye Blake
Address 60823 0
IMB 23
Emergency Department
The Townsville Hospital
100 Angus Smith Drive
Douglas, QLD
4814
Country 60823 0
Australia
Phone 60823 0
61 7 4433 1111
Fax 60823 0
Email 60823 0
[email protected]
Contact person for scientific queries
Name 60824 0
Dr Denise Faye Blake
Address 60824 0
IMB 23
Emergency Department
The Townsville Hospital
100 Angus Smith Drive
Douglas, QLD
4814
Country 60824 0
Australia
Phone 60824 0
61 7 4433 111
Fax 60824 0
Email 60824 0
[email protected]

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.