Perfusion; Complications
Conditions
Keywords
capillary refill time, peripheral perfusion
Brief 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.
Interventions
DEVICEcapillary refill index (CRI)
a waveform analysis method using a pulse oximeter to assess peripheral perfusion
Sponsors
Nihon Kohden
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Predictive Capability of the Altered Peripheral Perfusion | < 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
| Measure | Time frame | Description |
|---|---|---|
| Correlation of Device CRI to Conventional (Visual) CRT | < 30 min *right after enrollment | Spearman's correlation coefficient to assess the correlation between CRI and CRT values. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 57 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Discharged before study start | 1 |
| Overall Study | Nail polish could not be removed from finger | 1 |
| Overall Study | Pregnancy | 1 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 49.0 years |
| Fitzpatrick Skin Tone Scale Fitzpatrick skin tone - 1 | 9 participants |
| Fitzpatrick Skin Tone Scale Fitzpatrick skin tone - 2 | 13 participants |
| Fitzpatrick Skin Tone Scale Fitzpatrick skin tone - 3 | 14 participants |
| Fitzpatrick Skin Tone Scale Fitzpatrick skin tone - 4 | 7 participants |
| Fitzpatrick Skin Tone Scale Fitzpatrick skin tone - 5 | 7 participants |
| Fitzpatrick Skin Tone Scale Fitzpatrick skin tone - 6 | 7 participants |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 8 Participants |
| Race/Ethnicity, Customized No designation | 1 Participants |
| Race/Ethnicity, Customized Other/Multiracial | 13 Participants |
| Race/Ethnicity, Customized White | 32 Participants |
| Region of Enrollment United States | 57 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 57 |
| other Total, other adverse events | 0 / 57 |
| serious Total, serious adverse events | 0 / 57 |
Outcome results
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.
Time frame: < 30 min *right after enrollment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sensitivity and Specificity to Predict Low Peripheral Perfusion | Predictive Capability of the Altered Peripheral Perfusion | Optimal CRI (3.37 s) low peripheral perfusion sensitivity | 0.89 probability |
| Sensitivity and Specificity to Predict Low Peripheral Perfusion | Predictive Capability of the Altered Peripheral Perfusion | Optimal CRI (3.37 s) low peripheral perfusion specificity | 1.00 probability |
| Sensitivity and Specificity to Predict Low Peripheral Perfusion | Predictive Capability of the Altered Peripheral Perfusion | Optimal CRI (3.37 s) very low peripheral perfusion sensitivity | 0.94 probability |
| Sensitivity and Specificity to Predict Low Peripheral Perfusion | Predictive Capability of the Altered Peripheral Perfusion | Optimal CRI (3.37 s) very low peripheral perfusion specificity | 0.82 probability |
| Sensitivity and Specificity to Predict Low Peripheral Perfusion | Predictive Capability of the Altered Peripheral Perfusion | AUC low peripheral perfusion (> 2 s) | 0.986 probability |
| Sensitivity and Specificity to Predict Low Peripheral Perfusion | Predictive Capability of the Altered Peripheral Perfusion | AUC very low peripheral perfusion (> 3 s) | 0.910 probability |
Secondary
Correlation of Device CRI to Conventional (Visual) CRT
Spearman's correlation coefficient to assess the correlation between CRI and CRT values.
Time frame: < 30 min *right after enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sensitivity and Specificity to Predict Low Peripheral Perfusion | Correlation of Device CRI to Conventional (Visual) CRT | 0.866 Spearman's correlation coefficient |
Comparison: Mean value for visual CRT and median value for device CRI were calculated for each participant. 3 values were measured (each) for CRT and CRI. Mean value is equal to SUM(m1,m2,m3)/3.~Median value was then calculated for the set (57) of calculated mean visual CRT and mean device CRI. Median value is equal to the middle value of the series of mean values. All measurements are in units of seconds.See above
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
Time frame: < 30 min *right after enrollment
Population: Patients \< 60 years vs. \>= 60 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sensitivity and Specificity to Predict Low Peripheral Perfusion | Independence of Age Impact on CRI Measurement for Low Peripheral Perfusion (CRT > 2 Seconds) | 0.992 probabllity |
| All Subjects < 60 Years | Independence of Age Impact on CRI Measurement for Low Peripheral Perfusion (CRT > 2 Seconds) | 0.982 probabllity |
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
Time frame: < 30 min *right after enrollment
Population: Subjects with Fitzpatrick skin tone score of 1, 2 or 3 vs. scores of 4, 5, or 6
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sensitivity and Specificity to Predict Low Peripheral Perfusion | Independence of Fitzpatrick Skin Tone Score on CRI Measurement for Low Peripheral Perfusion (CRT > 2 Seconds) | 0.994 probability |
| All Subjects < 60 Years | Independence of Fitzpatrick Skin Tone Score on CRI Measurement for Low Peripheral Perfusion (CRT > 2 Seconds) | 0.981 probability |