Perfusion; ComplicationsCRINCT04144166

Evaluation of Capillary Refill Index

An observational study of Perfusion; Complications, run by Nihon Kohden at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Perfusion; Complications
What is being tested?: capillary refill index (CRI)
Type of treatment: Medical device
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 29 Oct 2019to 23 Dec 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adults in ED or admitted to ICU

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

North Shore University Hospital
Manhasset, New York, 11030

Other trials in United States

About this study

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

Read the 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.

Conditions: Perfusion; Complications
Being tested: capillary refill index (CRI)
Keywords: capillary refill time, peripheral perfusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

capillary refill index (CRI)Device
a waveform analysis method using a pulse oximeter to assess peripheral perfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: < 30 min *right after enrollment

Secondary outcomes (1)

Correlation of Device CRI to Conventional (Visual) CRT
Spearman's correlation coefficient to assess the correlation between CRI and CRT values.
Measured: < 30 min *right after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Oct 201923 Dec 2019

First posted30 Oct 2019
Study start29 Oct 2019
Primary completion4 Dec 2019
Study completion23 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Perfusion; ComplicationsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04144166
Sponsor's protocol ID: CS-011-004
Acronym: CRI
Status last verified: Jan 2021
First submitted: 28 Oct 2019
Last updated: 2 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Perfusion; Complications trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Capillary Refill Index
ClinicalTrials.gov ID: NCT04144166
Acronym / sponsor ID: CRI / CS-011-004
Conditions: Perfusion; Complications
Keywords: capillary refill time, peripheral perfusion
Study type: Observational
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Nihon KohdenIndustry (pharma, biotech, devices)
Study start: 29 Oct 2019 (actual)
Primary completion: 4 Dec 2019 (actual)
Study completion: 23 Dec 2019 (actual)
First posted: 30 Oct 2019 (actual)
Results: Posted 2 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Observational model: Cohort
Time perspective: Cross-sectional

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adults in ED or admitted to ICU

Key inclusion criteria (2 listed)

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)

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
capillary refill index (CRI)a waveform analysis method using a pulse oximeter to assess peripheral perfusion	Device	–

Primary outcome

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.

1 secondary outcome

Correlation of Device CRI to Conventional (Visual) CRT
Time frame: < 30 min *right after enrollment

Results and safety

Results posted to the registry on 2 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Subjects	60	57

Primary outcome: Predictive Capability of the Altered Peripheral Perfusion

Time frame: < 30 min *right after enrollment. Number (95% Confidence Interval). Unit: probability

Measure	Sensitivity and Specificity to Predict Low Peripheral Perfusion n = 57
Optimal CRI (3.37 s) low peripheral perfusion sensitivity	0.89 (0.71 to 0.98)
Optimal CRI (3.37 s) low peripheral perfusion specificity	1.00 (0.88 to 1.00)
Optimal CRI (3.37 s) very low peripheral perfusion sensitivity	0.94 (0.73 to 1.00)
Optimal CRI (3.37 s) very low peripheral perfusion specificity	0.82 (0.67 to 0.93)
AUC low peripheral perfusion (> 2 s)	0.986 (0.944 to 0.997)
AUC very low peripheral perfusion (> 3 s)	0.910 (0.807 to 0.960)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 30 min. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Subjects	0 of 57 (0%)	0 of 57 (0%)	0 of 57

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Perfusion; Complications

Recruiting
Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation
Liver Transplantation (LT), Ischemia-Reperfusion Injury
Not yet recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
Rectal Cancer Patients, Rectal Cancer Surgery
Not yet recruitingObservational study
Cumulative Intra-Abdominal Pressure Burden and Acute Kidney Injury After Emergency Abdominal Surgery
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RecruitingObservational study
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Not yet recruiting
BrainProtect-guided, Real-time Cerebral Autoregulation Monitoring and Protection of Brain During Cardiac Surgery With Cardiopulmonary Bypass Requiring Heart-lung Machine
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Timmy Li, PhD principal investigator

Admin Dir Clinical Research Emergency Medicine, Northwell Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Perfusion; Complications, run by Nihon Kohden at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Predictive Capability of the Altered Peripheral Perfusion (time frame: < 30 min *right after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04144166.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.