None listed
Conditions
Brief summary
The Compressive Redistribution Air Blanket (CRAB) is a recent invention with a primary aim of treating adrenaline resistant anaphylactic shock. Improved understanding of adrenaline resistant anaphylactic shock suggests the primary cause of hypotension is the venodilation, not vasodilation. Venodilation decreases Central Venous Pressure (CVP) resulting in poor cardiac filling and poor cardiac output. Adrenaline is a potent vasoconstrictor but does not significantly effect venodilation. When the CRAB is inflated to the pressures of just 20-40cm H2O the venous system in the abdomen and legs will be compressed and it is believed this will increase the central venous pressure, increase venous return to heart and restore blood pressure. This is a phase 1 clinical trial. The objective is to document the comfort / safety of the CRAB and find the relationship between CRAB Pressure and rise in CVP. In addition, it will be compared to current standard of care which increase CVP, the straight leg raise and Trendelenburg position. Twenty healthy volunteers will arrive fasted on the day of the study and have a midline line catheter inserted under ultrasound guidance in an arm vein to monitor the central venous pressure. A series of 2 minute inflations at 10,20,30 and 40 cmH2O and deflations will be monitored with CVP, ECG, BP & SaO2, and an assessment of comfort after each inflation. The protocol will be repeated after food, drink and IV hydration.
Interventions
This is a first clinical trial on this new device. The objective is to find the relationship between CRAB Pressure and rise in CVP and to document the comfort / safety of the CRAB. In addition, it will be compared to current standard of care which increase CVP, the straight leg raise and Trendelenburg position.
Twenty healthy volunteers will arrive fasted (from midnight) on the morning of the study.
They will have a midline line catheter inserted by an experienced expert, under ultrasound guida
This is a first clinical trial on this new device. The objective is to find the relationship between CRAB Pressure and rise in CVP and to document the comfort / safety of the CRAB. In addition, it will be compared to current standard of care which increase CVP, the straight leg raise and Trendelenburg position. Twenty healthy volunteers will arrive fasted (from midnight) on the morning of the study. They will have a midline line catheter inserted by an experienced expert, under ultrasound guidance in an arm vein with the catheter tip being placed in a central vein to monitor the central venous pressure. The CRAB is an inflatable bag - that will be strapped around the participant and bed by 4 large velcro straps. The top of the CRAB will be at the level of the xiphisternum. The interventions will be performed by an anaesthetist with an assistant in the room. The Intervention consists of a cycles of the CRAB being inflated for 2 minutes, then deflated for 2 minutes. The CRAb pressures during the 4 CRAB Cycles will be 10,20,30 and 40 cmH2O and deflation pressure will be zero. 2 further cycles of intervention will be performed with Straight leg elevation for 2 minutes, and 15 degrees Trendelenberg position. During the interventions the participants will be monitored with CVP, ECG, BP & SaO2, and asked to assessment the comfort after each inflation. This initial intervention will take 24 minutes. After the initial invention cycles the CRAB will be removed from the participant and they will fed with a sandwich and 2 glasses of a drink of their choice. They will also have 1 litre of CSL through their Midline catheter over a 30 minute period. The intervention protocol as listed above will then be repeated. 24minutes. At the completing of the second intervention protocol - the CRAB will be removed, The Midline Catheter removed (while lying flat) and the participant will need to wait 15 minutes before leaving. Total time from Start (insertion of midline catheter) to Finish(going home) 2.5- 3 hours
Sponsors
Coco Industries Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy ASA 1 & 2 participants. ASA 1 - A normal healthy patient eg Healthy, non-smoking, no or minimal alcohol use ASA 2 - A patient with mild systemic disease eg Mild diseases only without substantive functional limitations. Current smoker, social alcohol drinker, pregnancy, obesity (30<BMI<40), well-controlled DM/HTN, mild lung disease
Exclusion criteria
Pregnant Abdominal surgery in last 6 months. Cardiac Disease – Ischemic heart disease, Valvular disease, arrythmias, history of recurrent vasovagals (faints). Respiratory Disease – (Symptoms controlled mild asthma is OK) Any significant medical conditions Prescription medication for the cardiovascular or respiratory system.
Outcome results
None listed