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OpenTrials
Completed

NCT Number: NCT04144166

Evaluation of Capillary Refill Index

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

Completed

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Key information

Conditions

Perfusion; Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

North Shore University Hospital

Manhasset, New York, 11030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals 18 years of age or older
  • Patients who present to the ED or who are admitted to the ICU of North Shore University Hospital (NSUH)

Exclusion criteria

  • Pregnant
  • Prisoners
  • Finger, hand or forearm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor
  • Patients' deemed clinically unstable by the clinical team

Treatment and study plan

capillary refill index (CRI)

Device

a waveform analysis method using a pulse oximeter to assess peripheral perfusion

Primary outcomes

  1. Predictive Capability of the Altered Peripheral Perfusion

    Time frame: < 30 min *right after enrollment

    The area under the curve (AUC) of the receiver operator characteristic (ROC) curve analysis on CRI values to predict probability of altered peripheral perfusion determined with the CRT test.

Secondary outcomes

  1. Correlation of Device CRI to Conventional (Visual) CRT

    Time frame: < 30 min *right after enrollment

    Spearman's correlation coefficient to assess the correlation between CRI and CRT values.

Sponsors and collaborators

Lead sponsor

Nihon Kohden

Industry

Registry information

Acronym: CRI

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 30, 2019
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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