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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capillary refill index (CRI) | Device | a waveform analysis method using a pulse oximeter to assess peripheral perfusion |
| Measure | Description | Time Frame |
|---|---|---|
| Predictive Capability of the Altered Peripheral Perfusion | 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. | < 30 min *right after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of Device CRI to Conventional (Visual) CRT | Spearman's correlation coefficient to assess the correlation between CRI and CRT values. | < 30 min *right after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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Adults in ED or admitted to ICU
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| Name | Affiliation | Role |
|---|---|---|
| Timmy Li, PhD | Admin Dir Clinical Research Emergency Medicine, Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | Adult emergency department (ED) patients, both males and females without regards to ethnic and racial backgrounds. CRT and CRI measurements were conducted with following methods for each subject in a relaxed position (seated or lying down) with relaxed hands. The subject's most accessible hand (right or left) was used. Each measurement of visual CRT and device CRI were performed alternately and were repeated three times each for a total of six compressions per subject. Visual CRT measurement using a stopwatch An investigator (an ED physician) compressed the fingertip of the subject's index or middle finger for five seconds, signaled by "start compression" and "release compression" beep sounds. When the fingertip was released from the compression, the investigator began the visual CRT measurement. The investigator held a stopwatch in the hand that did not perform the compression and used this stopwatch to measure CRT. CRI measurement by the investigational device The SpO2 sensor probe was applied to either the index or middle fingertip of the same hand of the subject used in the CRT measurement, depending upon which fingertip was compressed in the CRT measurement. The investigator who measured the visual CRT was blinded from the measured value of the CRI measurement. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | Adult emergency department (ED) patients, both males and females without regards to ethnic and racial backgrounds. CRT and CRI measurements were conducted with following methods for each subject in a relaxed position (seated or lying down) with relaxed hands. The subject's most accessible hand (right or left) was used. Each measurement of visual CRT and device CRI were performed alternately and were repeated three times each for a total of six compressions per subject. Visual CRT measurement using a stopwatch An investigator (an ED physician) compressed the fingertip of the subject's index or middle finger for five seconds, signaled by "start compression" and "release compression" beep sounds. When the fingertip was released from the compression, the investigator began the visual CRT measurement. The investigator held a stopwatch in the hand that did not perform the compression and used this stopwatch to measure CRT. CRI measurement by the investigational device The SpO2 sensor probe was applied to either the index or middle fingertip of the same hand of the subject used in the CRT measurement, depending upon which fingertip was compressed in the CRT measurement. The investigator who measured the visual CRT was blinded from the measured value of the CRI measurement. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Predictive Capability of the Altered Peripheral Perfusion | 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. | Posted | Number | 95% Confidence Interval | probability | < 30 min *right after enrollment |
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30 min
All adverse events (all cause mortality, serious-adverse, other - not serious) reported to P.I. in written form via data collection form
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Subjects | Adult emergency department (ED) patients, both males and females without regards to ethnic and racial backgrounds. CRT and CRI measurements were conducted with following methods for each subject in a relaxed position (seated or lying down) with relaxed hands. The subject's most accessible hand (right or left) was used. Each measurement of visual CRT and device CRI were performed alternately and were repeated three times each for a total of six compressions per subject. Visual CRT measurement using a stopwatch An investigator (an ED physician) compressed the fingertip of the subject's index or middle finger for five seconds, signaled by "start compression" and "release compression" beep sounds. When the fingertip was released from the compression, the investigator began the visual CRT measurement. The investigator held a stopwatch in the hand that did not perform the compression and used this stopwatch to measure CRT. CRI measurement by the investigational device The SpO2 sensor probe was applied to either the index or middle fingertip of the same hand of the subject used in the CRT measurement, depending upon which fingertip was compressed in the CRT measurement. The investigator who measured the visual CRT was blinded from the measured value of the CRI measurement. |
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Sample size: Number of required sample size was 54. Detail of the sample size calculation is described in the clinical protocol document. Actual results were 57 subjects, so results are statistically valid with respect to sample size.
Participant flow: Subject discovered to be pregnant and removed from study. Since study is non-invasive and minimal risk, subject and fetus were not exposed to any additional risks. Hospital IRB was notified of deviation and did not require other reporting.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research for Emergency Medicine | North Shore University Hospital | (516) 562-1513 | TLi2@northwell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 2, 2019 | Nov 9, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 27, 2019 | Nov 9, 2020 | ICF_001.pdf |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Fitzpatrick Skin Tone Scale | Fitzpatrick skin tone scale is a numerical classification schema for human skin color. The scales range from 1 - fairest skin to 6 - very dark pigment skin. A visual chart comparison was used for assignment of each subject. Results (see later) only addressed a comparison of subjects in Fitzpatrick 1, 2 or 3 versus subjects in Fitzpatrick 4, 5 of 6. | Number | participants |
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| Secondary | Correlation of Device CRI to Conventional (Visual) CRT | Spearman's correlation coefficient to assess the correlation between CRI and CRT values. | Posted | Number | 95% Confidence Interval | Spearman's correlation coefficient | < 30 min *right after enrollment |
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| Post-Hoc | Independence of Age Impact on CRI Measurement for Low Peripheral Perfusion (CRT > 2 Seconds) | Demonstrate that age is not a variant for CRI measurement | Patients < 60 years vs. >= 60 years | Posted | Number | 95% Confidence Interval | probabllity | < 30 min *right after enrollment |
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| Post-Hoc | Independence of Fitzpatrick Skin Tone Score on CRI Measurement for Low Peripheral Perfusion (CRT > 2 Seconds) | Demonstrate that skin tone is not a variant for CRI measurement | Subjects with Fitzpatrick skin tone score of 1, 2 or 3 vs. scores of 4, 5, or 6 | Posted | Number | 95% Confidence Interval | probability | < 30 min *right after enrollment |
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| 0 |
| 57 |
| 0 |
| 57 |
| 0 |
| 57 |
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