Cardiogenic Shock, Digital Ischemia, Hypovolemic Shock
Conditions
Brief summary
Patients requiring high dose pressors (minimum 2) who are unlikely to be weaned off them over 1 day will be identified. Patients will have the device applied to one hand while expectant medical management will continue to the contralateral hand.
Detailed description
The proposed study offers no foreseeable risk to patients. The device relies on a wound vac system for vacuum generation which is industry standard and approved for creating safe suction applied to wounds. In this application, the same suction and device would be used to apply suction to an enclosure through which the hand is placed. Similarly, a heat exchanger would be used to run lukewarm water through a warming bad, which is technology that is routinely used in surgery. Heater coolers are used in every bypass surgery, and warming fluid blankets are common for helping to rewarm patients on the operating room table.
Interventions
DEVICEthe combined use of vacuum assisted suction and heat exchanger warming
Heat causes capillary vasodilation, where warming hands and toes improves blood flow while cooling them causes vasoconstriction. Applying a vacuum across a capillary bed increases the transcapillary gradient increasing the driving force of blood flow into tissues. The combination of these two mechanisms can work synchronously to improve blood flow to ischemic extremities and digits.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Each patient will act as their own control. By applying the vacuum assisted warmer to one hand, results can be compared to the contralateral hand. In this way, patient outcomes can be assessed between patients and indexed to each patient.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients in the cardiac critical care unit/cardiovascular intensive care unit with cardiac pathologies on vasopressor support
Exclusion criteria
* Patients who are not on vasopressor support * Patients under the age of 18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of digital ischemia | Day 14 | rate of digital ischemia characterized by tissue loss or destruction - measure incidence rate as a ratio of patients who got digital ischemia with the number of patients who were on vasopressors |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| extent of digital ischemia - number of digits involved | Day 14 | extent of digital ischemia - determined by number of digits involved |
| extent of digital ischemia - length of digits involved | Day 14 | extent of digital ischemia - determined by degree of length of digits involved (like distal finger joint, proximal finger joint, entire finger, into the palm, etc) |
Outcome results
None listed