Evaluation of Capillary Refill Index

NCT ID: NCT04144166

Last Updated: 2021-02-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-29

Study Completion Date

2019-12-23

Brief Summary

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

Detailed Description

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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

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Perfusion; Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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capillary refill index (CRI)

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Pregnant
2. Prisoners
3. Finger, hand or forearm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor
4. Patients' deemed clinically unstable by the clinical team
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nihon Kohden

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timmy Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Admin Dir Clinical Research Emergency Medicine, Northwell Health

Locations

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North Shore University Hospital

Manhasset, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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CS-011-004

Identifier Type: -

Identifier Source: org_study_id

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