NCT05661773

Digital Ischemia Reduction in Critically Ill Patients

Assessing the Effect of Vacuum Suction on Digital Ischemia in Critically Ill Patients

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypovolemic Shock
• Cardiogenic Shock
• Digital Ischemia

Interventions

Type	Name	Description
DEVICE	the 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.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2022-12-22
• Last updated: 2023-11-01

Regulatory

• FDA-regulated device study