Trial Outcomes & Findings for Evaluation of Capillary Refill Index (NCT NCT04144166)

NCT ID: NCT04144166

Last Updated: 2021-02-02

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 60 participants
• Primary outcome timeframe: < 30 min *right after enrollment
• Results posted on: 2021-02-02

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	60
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	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.
Overall Study Discharged before study start	1
Overall Study Pregnancy	1
Overall Study Nail polish could not be removed from finger	1

Baseline Characteristics

Evaluation of Capillary Refill Index

Baseline characteristics by cohort

Measure	All Subjects n=57 Participants 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.
Age, Continuous	49.0 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants
Race/Ethnicity, Customized White	32 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	8 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized Other/Multiracial	13 Participants n=5 Participants
Race/Ethnicity, Customized No designation	1 Participants n=5 Participants
Region of Enrollment United States	57 Participants n=5 Participants
Fitzpatrick Skin Tone Scale Fitzpatrick skin tone - 1	9 participants n=5 Participants
Fitzpatrick Skin Tone Scale Fitzpatrick skin tone - 2	13 participants n=5 Participants
Fitzpatrick Skin Tone Scale Fitzpatrick skin tone - 3	14 participants n=5 Participants
Fitzpatrick Skin Tone Scale Fitzpatrick skin tone - 4	7 participants n=5 Participants
Fitzpatrick Skin Tone Scale Fitzpatrick skin tone - 5	7 participants n=5 Participants
Fitzpatrick Skin Tone Scale Fitzpatrick skin tone - 6	7 participants n=5 Participants

PRIMARY outcome

Timeframe: < 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.

Outcome measures

Measure	Sensitivity and Specificity to Predict Low Peripheral Perfusion n=57 Participants Ability to differentiate altered peripheral perfusion with a CRI cutoff value of 3.37 s for low CRT (\> 2 s) and very low CRT (\> 3 s)	All Subjects < 60 Years All subjects \< 60 years
Predictive Capability of the Altered Peripheral Perfusion Optimal CRI (3.37 s) low peripheral perfusion sensitivity	0.89 probability Interval 0.71 to 0.98	—
Predictive Capability of the Altered Peripheral Perfusion Optimal CRI (3.37 s) low peripheral perfusion specificity	1.00 probability Interval 0.88 to 1.0	—
Predictive Capability of the Altered Peripheral Perfusion Optimal CRI (3.37 s) very low peripheral perfusion sensitivity	0.94 probability Interval 0.73 to 1.0	—
Predictive Capability of the Altered Peripheral Perfusion Optimal CRI (3.37 s) very low peripheral perfusion specificity	0.82 probability Interval 0.67 to 0.93	—
Predictive Capability of the Altered Peripheral Perfusion AUC low peripheral perfusion (> 2 s)	0.986 probability Interval 0.944 to 0.997	—
Predictive Capability of the Altered Peripheral Perfusion AUC very low peripheral perfusion (> 3 s)	0.910 probability Interval 0.807 to 0.96	—

SECONDARY outcome

Timeframe: < 30 min *right after enrollment

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

Outcome measures

Measure	Sensitivity and Specificity to Predict Low Peripheral Perfusion n=57 Participants Ability to differentiate altered peripheral perfusion with a CRI cutoff value of 3.37 s for low CRT (\> 2 s) and very low CRT (\> 3 s)	All Subjects < 60 Years All subjects \< 60 years
Correlation of Device CRI to Conventional (Visual) CRT	0.866 Spearman's correlation coefficient Interval 0.782 to 0.919	—

POST_HOC outcome

Timeframe: < 30 min *right after enrollment

Population: Patients \< 60 years vs. \>= 60 years

Demonstrate that age is not a variant for CRI measurement

Outcome measures

Measure	Sensitivity and Specificity to Predict Low Peripheral Perfusion n=23 Participants Ability to differentiate altered peripheral perfusion with a CRI cutoff value of 3.37 s for low CRT (\> 2 s) and very low CRT (\> 3 s)	All Subjects < 60 Years n=34 Participants All subjects \< 60 years
Independence of Age Impact on CRI Measurement for Low Peripheral Perfusion (CRT > 2 Seconds)	0.992 probabllity Interval 0.888 to 1.0	0.982 probabllity Interval 0.901 to 1.0

POST_HOC outcome

Timeframe: < 30 min *right after enrollment

Population: Subjects with Fitzpatrick skin tone score of 1, 2 or 3 vs. scores of 4, 5, or 6

Demonstrate that skin tone is not a variant for CRI measurement

Outcome measures

Measure	Sensitivity and Specificity to Predict Low Peripheral Perfusion n=36 Participants Ability to differentiate altered peripheral perfusion with a CRI cutoff value of 3.37 s for low CRT (\> 2 s) and very low CRT (\> 3 s)	All Subjects < 60 Years n=21 Participants All subjects \< 60 years
Independence of Fitzpatrick Skin Tone Score on CRI Measurement for Low Peripheral Perfusion (CRT > 2 Seconds)	0.994 probability Interval 0.993 to 1.0	0.981 probability Interval 0.82 to 0.998

Adverse Events

All Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Research for Emergency Medicine

North Shore University Hospital

Phone: (516) 562-1513

Email: TLi2@northwell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60