Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000840886p
Ethics application status
Submitted, not yet approved
Date submitted
17/05/2021
Date registered
1/07/2021
Date last updated
28/06/2022
Date data sharing statement initially provided
1/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the cardiovascular effects of the Compressive Redistribution Air Blanket (CRAB) on healthy volunteers
Scientific title
Evaluating the cardiovascular effects of the Compressive Redistribution Air Blanket (CRAB) on healthy volunteers
Secondary ID [1] 304234 0
None
Universal Trial Number (UTN)
U1111-1267-4979
Trial acronym
CRAB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central venous pressure 321942 0
Condition category
Condition code
Anaesthesiology 319673 319673 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 320572 0
Treatment: Devices
Comparator / control treatment
The primary outcome of this trial is to quantify the relationship between CRAB Pressure and rise in CVP. Therefore each participant will be their own control. The 2min of No Pressure in the CRAB will give the baseline CVP, compared against the CVP while the CRAB is pressurised.
Control group
Active

Outcomes
Primary outcome [1] 327549 0
Change in Central Venous Pressure for varying pressures in the CRAB. (10,20,30&40cm H2O)
This will assessed by a pressure transducers connected to a midline catheter positioned in a central vein.
Timepoint [1] 327549 0
The Central venous pressure (CVP) will be monitored constantly (for 24 min) throughout every cycle of the interventions.. The baseline CVP will be the CVP just prior to each 2 minute intervention (inflation of the CRAB, Straight leg raise or Trendelenberg position). The change in CVP will be defined as the Change in CVP from baseline CVP to the maximal CVP during the 2 minutes of each intervention.
Secondary outcome [1] 395624 0
Participant comfort after each cycle of interventions.
It will be measured with a Visual Analogue Score (VAS) 0-10 Comfort, Tolerability, difficulty breathing


Timepoint [1] 395624 0
The Comfort / Complications will be assess after each series of interventions.
It will be measured twice - after the fasting cycle of interventions, and after the hydrated cycle of interventions.
Secondary outcome [2] 396765 0
Blood Pressure (BP) change during each intervention.
It will be measure using a constant non invasive Finger BP monitor.
Timepoint [2] 396765 0
The BP will be monitored constantly (for 24 min) throughout every cycle of the interventions.. The baseline BP will be the BP just prior to each 2 minute intervention (inflation of the CRAB, Straight leg raise or Trendelenberg position). The change in BP will be defined as the Change in BP from baseline BP to the maximal BP during the 2 minutes of each intervention.
Secondary outcome [3] 396766 0
Heart Rate (HR)change during each intervention.
Measure with a Pulse oximeter.
Timepoint [3] 396766 0
The HR will be monitored constantly (for 24 min) throughout every cycle of the interventions.. The baseline HR will be the HR just prior to each 2 minute intervention (inflation of the CRAB, Straight leg raise or Trendelenberg position). The change in HR will be defined as the Change in HR from baseline HR to the maximal HR during the 2 minutes of each intervention.
Secondary outcome [4] 396767 0
Oxygen Saturation (SaO2) change during each intervention.
Measure with a Pulse oximeter.
Timepoint [4] 396767 0
The (SaO2) will be monitored constantly (for 24 min) throughout every cycle of the interventions.. The baseline SaO2 will be the SaO2 just prior to each 2 minute intervention (inflation of the CRAB, Straight leg raise or Trendelenberg position). The change in SaO2 will be defined as the Change in SaO2 from baseline SaO2 to the lowest SaO2 during the 2 minutes of each intervention.
Secondary outcome [5] 397125 0
Participant tolerability
It will be measured with a Visual Analogue Score (VAS) 0-10 for Tolerability.
Timepoint [5] 397125 0
It will be measured twice - after the fasting cycle of interventions, and after the hydrated cycle of interventions.
Secondary outcome [6] 397126 0
Difficulty Breathing
It will be measured with a Visual Analogue Score (VAS) 0-10 for Difficulty Breathing.
Timepoint [6] 397126 0
It will be measured twice - after the fasting cycle of interventions, and after the hydrated cycle of interventions.
Secondary outcome [7] 397127 0
Pain
It will be measured with a Visual Analogue Score (VAS) 0-10 for Pain
Timepoint [7] 397127 0
It will be measured twice - after the fasting cycle of interventions, and after the hydrated cycle of interventions

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistics : Continuous outcome measures will be summarised using means, standard deviations, medians and ranges..
Sample Size : There have been no previous investigation of this product to have an expected mean and standard deviation change in CVP for any CRAB Pressure.
A sample size of 20 has been chosen as =
This is a commonly the size for "phase 1" simple interventional trials.
The intervention is highly unlikely to cause harm so there is minimal risk associated with this number.
The primary endpoints is the change in CVP. 20 participants with 5 CRAB data points (0,10,20,30,40 cmH2O) should allow precise determination of the mean change in CVP for each 10cmH2O of CRAB pressure.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/07/2022
Actual
Date of last participant enrolment
Anticipated
30/11/2022
Actual
Date of last data collection
Anticipated
30/11/2022
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 19468 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 34060 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 308612 0
Commercial sector/Industry
Name [1] 308612 0
Coco Industries Pty Ltd
Country [1] 308612 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Coco Industries Pty Ltd
Address
18 Jameson St
Swanbourne 6010
Western Australia
Australia
Country
Australia
Secondary sponsor category [1] 309480 0
None
Name [1] 309480 0
Address [1] 309480 0
Country [1] 309480 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308544 0
Sir Charles Gairdner and Osborne Park Health Care Group HREC
Ethics committee address [1] 308544 0
SCGH HREC
Level 2, A Block, QEII Medical Centre
Hospital Avenue
Nedlands 6008
Western Australia
Ethics committee country [1] 308544 0
Australia
Date submitted for ethics approval [1] 308544 0
11/06/2021
Approval date [1] 308544 0
15/06/2022
Ethics approval number [1] 308544 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111082 0
Dr Christopher Mitchell
Address 111082 0
Anaesthetic Department
Sir Charles Gairdner Hospital
Hospital Drive
Nedlands 6008
Western Australia
Country 111082 0
Australia
Phone 111082 0
+61 0427 425854
Fax 111082 0
Email 111082 0
[email protected]
Contact person for public queries
Name 111083 0
Dr Christopher Mitchell
Address 111083 0
Anaesthetic Department
Sir Charles Gairdner Hospital
Hospital Drive
Nedlands 6008
Western Australia
Country 111083 0
Australia
Phone 111083 0
+61 0427 425854
Fax 111083 0
Email 111083 0
[email protected]
Contact person for scientific queries
Name 111084 0
Dr Christopher Mitchell
Address 111084 0
Anaesthetic Department
Sir Charles Gairdner Hospital
Hospital Drive
Nedlands 6008
Western Australia
Country 111084 0
Australia
Phone 111084 0
+61 0427 425854
Fax 111084 0
Email 111084 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




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.