Assessing the Effect of Vacuum Suction on Digital Ischemia in Critically Ill Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Primary Endpoint
- Incidence of digital ischemia
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
combined use of vacuum assisted suction and heat exchanger warming
The novel idea that this study proposes, is the combined use of vacuum assisted suction and heat exchanger warming. It is well known that 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.
Intervention: the combined use of vacuum assisted suction and heat exchanger warming (Device)
expectant medical management
expectant medical management will continue to the contralateral hand
Outcomes
Primary Outcomes
Incidence of digital ischemia
Time Frame: 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 Outcomes
- extent of digital ischemia - length of digits involved(Day 14)
- extent of digital ischemia - number of digits involved(Day 14)