None listed
Conditions
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.
Interventions
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 contai
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).
Sponsors
James Cook University
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
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
Outcome results
None listed