NCT04144166

Evaluation of Capillary Refill Index

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Nihon Kohden · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Comparison of a peripheral perfusion assessment method using a pulse oximeter to the conventional capillary refill time visually assessed by a clinician.

Detailed description

A new technology, capillary refill index (CRI), to assess peripheral perfusion status quantitatively using pulse oximeter waveforms is being developed. The conventional capillary refill time (CRT) is widely used in clinical settings as a gold standard to assess peripheral perfusion. The objective of this study is to evaluate the capability of CRI to predict altered peripheral perfusion determined with the conventional CRT test. Predictive capability of CRI needs to be assessed to achieve a goal to provide clinicians with an alternative method to the conventional CRT.

Conditions

• Perfusion; Complications

Interventions

Type	Name	Description
DEVICE	capillary refill index (CRI)	a waveform analysis method using a pulse oximeter to assess peripheral perfusion

Timeline

• Start date: 2019-10-29
• Primary completion: 2019-12-04
• Completion: 2019-12-23
• First posted: 2019-10-30
• Last updated: 2021-02-02
• Results posted: 2021-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study