Peripheral PerfusionCRINCT04366310
Capillary Refill Index with Rewarming
An observational study of Peripheral Perfusion, run by Nihon Kohden at 1 site in United States.
Trial summary
A new technology, capillary refill index (CRI) can be useful for assessing peripheral perfusion status quantitatively, but this value can be influenced by fingertip temperature. The aim of this study is to evaluate the predictive accuracy of CRI after a temperature control (warming) procedure in predicting 30-day… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Perfusion
- What is being tested?
- capillary refill index and rewarming
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2020to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Adult intensive care unit (ICU) patients (both males and females without regards to ethnic and racial backgrounds)
Who may be able to join
- 18 years of age or older;
- Admitted to any ICU of North Shore University Hospital (NSUH) within 24 hours
Who cannot join
- Pregnant
- Prisoners
- Finger, hand or forearm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor
- Patients who are not deemed clinically stable by the clinical team
- Wearing nail polish, nail gel, or nail decorations
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore University Hospital
Manhasset, New York, 11030
About this study
Official title: Capillary Refill Index Measurement with a Temperature Control Procedure
A new technology, capillary refill index (CRI) can be useful for assessing peripheral perfusion status quantitatively, but this value can be influenced by fingertip temperature. The aim of this study is to evaluate the predictive accuracy of CRI after a temperature control (warming) procedure in predicting 30-day mortality among ICU/CCU patients. The investigators hypothesized that lowered fingertip temperature can lead prolonged CRI values which are considered as false positives in detection of high-risk patients for mortality, because it causes poor peripheral perfusion which does not reflect hemodynamic instability. The investigators will use the warming procedure to remove or reduce the effect of the fingertip temperature on the CRI measurement and will analyze whether it contributes to reduction of false positives in detection of high-risk patients for mortality.
Read the detailed description
Capillary refill time (CRT) test is a simple and noninvasive method typically used to assess peripheral blood perfusion at the bedside. CRT is defined as the time required for a distal capillary bed (e.g., fingertip) to regain its color after having received enough compression to cause blanching [1]. Because a prolonged CRT suggests a decrease in peripheral perfusion and poor peripheral perfusion is strongly associated with patients' mortality, several studies reported the clinical usefulness of CRT for predicting patients' mortality in the critical care setting [2,3]. However, because the conventional CRT test depends on clinicians' subjective visual assessment, the inter-rater agreement of it has been questioned, and substantial clinical experience is needed to acquire the reliable skill to measure CRT [4, 5, 6, 7]. Therefore, there is great demand for the creation of objective methods to easily assess peripheral blood perfusion.
Previously, the investigators developed a new mechanical device by using pulse oximetry waveforms, which can enable us to measure CRT easily and objectively. The measurement obtained with this device is called Capillary Refill Index (CRI) to differentiate it from traditional visual assessment of CRT [8]. The method calculates the time it takes for blood to return to the fingertip after release from compression by algorithmically analyzing the light intensity waveform of a normal pulse oximeter sensor attached to a patient's fingertip. The investigators' previous study showed that CRI can be an alternative to traditional CRT for assessing peripheral blood perfusion [8, 9, 10].
In the investigators previous study with healthy volunteer subjects [11], the investigators found that lowered fingertip temperature is a critical component that affects measurement values of CRI, which is the same phenomena with the traditional CRT. Since lowered skin temperature causes poor peripheral perfusion, the patients with lower fingertip temperature can show prolonged CRI without reflecting hemodynamic instability, which means lower skin temperature can increase false positives when using CRI to detect patients at high risk for mortality. The investigators hypothesize that the predictive accuracy of CRI for detecting patients at increased risk for mortality may be improved if the patients' skin temperature is warmed up before the measurement.
- Conditions
- Peripheral Perfusion
- Being tested
- capillary refill index, rewarming
- 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 indexDevice
Also called CRI
a waveform analysis method using a pulse oximeter to assess peripheral perfusion
rewarmingProcedure or surgery
warming fingertip skin temperature using an instant hot pack
| Study group | Role | What they receive |
|---|---|---|
| capillary refill index (CRI) | a waveform analysis method using a pulse oximeter to assess peripheral perfusion Receives: Device: capillary refill index; Procedure: rewarming |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of ROC curve for 30 days mortality
Receiver operator characteristic (ROC) curve analysis of CRI after the temperature control procedure for 30 days mortality of ICU patients will be performed and area under the curve (AUC) will be calculated.
Measured: 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start16 Nov 2020
- Primary completion1 Mar 2022
- Study completion1 Mar 2023
Why it stopped: Insufficient enrollment to achieve outcomes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Peripheral PerfusionStudies 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
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nihon Kohden
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timmy Li, PhD, Principal investigator, Administrative Director Clinical Research Emergency Medicine, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366310
- Sponsor's protocol ID
- A960-055244
- Other IDs
- 20-0310
- Acronym
- CRI
- Status last verified
- Dec 2024
- First submitted
- 20 Apr 2020
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Schriger DL, Baraff L. Defining normal capillary refill: variation with age, sex, and temperature. Ann Emerg Med. 1988 Sep;17(9):932-5. doi: 10.1016/s0196-0644(88)80675-9.
PubMed 3415066Lima A, Jansen TC, van Bommel J, Ince C, Bakker J. The prognostic value of the subjective assessment of peripheral perfusion in critically ill patients. Crit Care Med. 2009 Mar;37(3):934-8. doi: 10.1097/CCM.0b013e31819869db.
PubMed 19237899Ait-Oufella H, Bige N, Boelle PY, Pichereau C, Alves M, Bertinchamp R, Baudel JL, Galbois A, Maury E, Guidet B. Capillary refill time exploration during septic shock. Intensive Care Med. 2014 Jul;40(7):958-64. doi: 10.1007/s00134-014-3326-4. Epub 2014 May 9.
PubMed 24811942van Genderen ME, Paauwe J, de Jonge J, van der Valk RJ, Lima A, Bakker J, van Bommel J. Clinical assessment of peripheral perfusion to predict postoperative complications after major abdominal surgery early: a prospective observational study in adults. Crit Care. 2014 Jun 3;18(3):R114. doi: 10.1186/cc13905.
PubMed 24894892Alsma J, van Saase JLCM, Nanayakkara PWB, Schouten WEMI, Baten A, Bauer MP, Holleman F, Ligtenberg JJM, Stassen PM, Kaasjager KHAH, Haak HR, Bosch FH, Schuit SCE; FAMOUS Study Group*. The Power of Flash Mob Research: Conducting a Nationwide Observational Clinical Study on Capillary Refill Time in a Single Day. Chest. 2017 May;151(5):1106-1113. doi: 10.1016/j.chest.2016.11.035. Epub 2016 Dec 7.
PubMed 27940191Pickard A, Karlen W, Ansermino JM. Capillary refill time: is it still a useful clinical sign? Anesth Analg. 2011 Jul;113(1):120-3. doi: 10.1213/ANE.0b013e31821569f9. Epub 2011 Apr 25.
PubMed 21519051Shinozaki K, Jacobson LS, Saeki K, Kobayashi N, Weisner S, Falotico JM, Li T, Kim J, Lampe JW, Becker LB. Does training level affect the accuracy of visual assessment of capillary refill time? Crit Care. 2019 May 6;23(1):157. doi: 10.1186/s13054-019-2444-3. No abstract available.
PubMed 31060576Shinozaki K, Saeki K, Jacobson LS, Falotico JM, Li T, Hirahara H, Horie K, Kobayashi N, Weisner S, Lampe JW, Becker LB. Evaluation of accuracy of capillary refill index with pneumatic fingertip compression. J Clin Monit Comput. 2021 Feb;35(1):135-145. doi: 10.1007/s10877-019-00454-1. Epub 2020 Jan 8.
PubMed 31916222Shinozaki K, Capilupi MJ, Saeki K, Hirahara H, Horie K, Kobayashi N, Weisner S, Kim J, Lampe JW, Becker LB. Blood refill time: Clinical bedside monitoring of peripheral blood perfusion using pulse oximetry sensor and mechanical compression. Am J Emerg Med. 2018 Dec;36(12):2310-2312. doi: 10.1016/j.ajem.2018.04.006. Epub 2018 Apr 5. No abstract available.
PubMed 29678295Shinozaki K, Jacobson LS, Saeki K, Hirahara H, Kobayashi N, Weisner S, Falotico JM, Li T, Kim J, Becker LB. Comparison of point-of-care peripheral perfusion assessment using pulse oximetry sensor with manual capillary refill time: clinical pilot study in the emergency department. J Intensive Care. 2019 Nov 27;7:52. doi: 10.1186/s40560-019-0406-0. eCollection 2019.
PubMed 31798887Shinozaki K, Capilupi MJ, Saeki K, Hirahara H, Horie K, Kobayashi N, Weisner S, Kim J, Lampe JW, Becker LB. Low temperature increases capillary blood refill time following mechanical fingertip compression of healthy volunteers: prospective cohort study. J Clin Monit Comput. 2019 Apr;33(2):259-267. doi: 10.1007/s10877-018-0159-7. Epub 2018 May 30.
PubMed 29846867
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capillary Refill Index Measurement with a Temperature Control Procedure
- ClinicalTrials.gov ID
- NCT04366310
- Acronym / sponsor ID
- CRI / A960-055244
- Conditions
- Peripheral Perfusion
- Keywords
- capillary refill time, peripheral perfusion
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment to achieve outcomes
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Nihon KohdenIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A new technology, capillary refill index (CRI) can be useful for assessing peripheral perfusion status quantitatively, but this value can be influenced by fingertip temperature. The aim of this study is to evaluate the predictive accuracy of CRI after a temperature control (warming) procedure in predicting 30-day mortality among ICU/CCU patients. The investigators hypothesized that lowered fingertip temperature can lead prolonged CRI values which are considered as false positives in detection of high-risk patients for mortality, because it causes poor peripheral perfusion which does not reflect hemodynamic instability. The investigators will use the warming procedure to remove or reduce the effect of the fingertip temperature on the CRI measurement and will analyze whether it contributes to reduction of false positives in detection of high-risk patients for mortality.
Detailed description
Capillary refill time (CRT) test is a simple and noninvasive method typically used to assess peripheral blood perfusion at the bedside. CRT is defined as the time required for a distal capillary bed (e.g., fingertip) to regain its color after having received enough compression to cause blanching [1]. Because a prolonged CRT suggests a decrease in peripheral perfusion and poor peripheral perfusion is strongly associated with patients' mortality, several studies reported the clinical usefulness of CRT for predicting patients' mortality in the critical care setting [2,3]. However, because the conventional CRT test depends on clinicians' subjective visual assessment, the inter-rater agreement of it has been questioned, and substantial clinical experience is needed to acquire the reliable skill to measure CRT [4, 5, 6, 7]. Therefore, there is great demand for the creation of objective methods to easily assess peripheral blood perfusion.
Previously, the investigators developed a new mechanical device by using pulse oximetry waveforms, which can enable us to measure CRT easily and objectively. The measurement obtained with this device is called Capillary Refill Index (CRI) to differentiate it from traditional visual assessment of CRT [8]. The method calculates the time it takes for blood to return to the fingertip after release from compression by algorithmically analyzing the light intensity waveform of a normal pulse oximeter sensor attached to a patient's fingertip. The investigators' previous study showed that CRI can be an alternative to traditional CRT for assessing peripheral blood perfusion [8, 9, 10].
In the investigators previous study with healthy volunteer subjects [11], the investigators found that lowered fingertip temperature is a critical component that affects measurement values of CRI, which is the same phenomena with the traditional CRT. Since lowered skin temperature causes poor peripheral perfusion, the patients with lower fingertip temperature can show prolonged CRI without reflecting hemodynamic instability, which means lower skin temperature can increase false positives when using CRI to detect patients at high risk for mortality. The investigators hypothesize that the predictive accuracy of CRI for detecting patients at increased risk for mortality may be improved if the patients' skin temperature is warmed up before the measurement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| capillary refill index (CRI) | – | Device: capillary refill index, Procedure: rewarminga waveform analysis method using a pulse oximeter to assess peripheral perfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult intensive care unit (ICU) patients (both males and females without regards to ethnic and racial backgrounds)
Key inclusion criteria (2 listed)
- 18 years of age or older;
- Admitted to any ICU of North Shore University Hospital (NSUH) within 24 hours
Key exclusion criteria (5 listed)
- Pregnant
- Prisoners
- Finger, hand or forearm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor
- Patients who are not deemed clinically stable by the clinical team
- Wearing nail polish, nail gel, or nail decorations
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 indexAlso: CRIa waveform analysis method using a pulse oximeter to assess peripheral perfusion | Device | capillary refill index (CRI) |
| rewarmingwarming fingertip skin temperature using an instant hot pack | Procedure or surgery | capillary refill index (CRI) |
Primary outcome
AUC of ROC curve for 30 days mortality
Time frame: 31 days
Receiver operator characteristic (ROC) curve analysis of CRI after the temperature control procedure for 30 days mortality of ICU patients will be performed and area under the curve (AUC) will be calculated.
Results and safety
The study was stopped early (reason given: Insufficient enrollment to achieve outcomes). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: PubMed 3415066Schriger DL, Baraff L. Defining normal capillary refill: variation with age, sex, and temperature. Ann Emerg Med. 1988 Sep;17(9):932-5. doi: 10.1016/s0196-0644(88)80675-9.
- Background: PubMed 19237899Lima A, Jansen TC, van Bommel J, Ince C, Bakker J. The prognostic value of the subjective assessment of peripheral perfusion in critically ill patients. Crit Care Med. 2009 Mar;37(3):934-8. doi: 10.1097/CCM.0b013e31819869db.
- Background: PubMed 24811942Ait-Oufella H, Bige N, Boelle PY, Pichereau C, Alves M, Bertinchamp R, Baudel JL, Galbois A, Maury E, Guidet B. Capillary refill time exploration during septic shock. Intensive Care Med. 2014 Jul;40(7):958-64. doi: 10.1007/s00134-014-3326-4. Epub 2014 May 9.
- Background: PubMed 24894892van Genderen ME, Paauwe J, de Jonge J, van der Valk RJ, Lima A, Bakker J, van Bommel J. Clinical assessment of peripheral perfusion to predict postoperative complications after major abdominal surgery early: a prospective observational study in adults. Crit Care. 2014 Jun 3;18(3):R114. doi: 10.1186/cc13905.
- Background: PubMed 27940191Alsma J, van Saase JLCM, Nanayakkara PWB, Schouten WEMI, Baten A, Bauer MP, Holleman F, Ligtenberg JJM, Stassen PM, Kaasjager KHAH, Haak HR, Bosch FH, Schuit SCE; FAMOUS Study Group*. The Power of Flash Mob Research: Conducting a Nationwide Observational Clinical Study on Capillary Refill Time in a Single Day. Chest. 2017 May;151(5):1106-1113. doi: 10.1016/j.chest.2016.11.035. Epub 2016 Dec 7.
- Background: PubMed 21519051Pickard A, Karlen W, Ansermino JM. Capillary refill time: is it still a useful clinical sign? Anesth Analg. 2011 Jul;113(1):120-3. doi: 10.1213/ANE.0b013e31821569f9. Epub 2011 Apr 25.
- Background: PubMed 31060576Shinozaki K, Jacobson LS, Saeki K, Kobayashi N, Weisner S, Falotico JM, Li T, Kim J, Lampe JW, Becker LB. Does training level affect the accuracy of visual assessment of capillary refill time? Crit Care. 2019 May 6;23(1):157. doi: 10.1186/s13054-019-2444-3. No abstract available.
- Background: PubMed 31916222Shinozaki K, Saeki K, Jacobson LS, Falotico JM, Li T, Hirahara H, Horie K, Kobayashi N, Weisner S, Lampe JW, Becker LB. Evaluation of accuracy of capillary refill index with pneumatic fingertip compression. J Clin Monit Comput. 2021 Feb;35(1):135-145. doi: 10.1007/s10877-019-00454-1. Epub 2020 Jan 8.
- Background: PubMed 29678295Shinozaki K, Capilupi MJ, Saeki K, Hirahara H, Horie K, Kobayashi N, Weisner S, Kim J, Lampe JW, Becker LB. Blood refill time: Clinical bedside monitoring of peripheral blood perfusion using pulse oximetry sensor and mechanical compression. Am J Emerg Med. 2018 Dec;36(12):2310-2312. doi: 10.1016/j.ajem.2018.04.006. Epub 2018 Apr 5. No abstract available.
- Background: PubMed 31798887Shinozaki K, Jacobson LS, Saeki K, Hirahara H, Kobayashi N, Weisner S, Falotico JM, Li T, Kim J, Becker LB. Comparison of point-of-care peripheral perfusion assessment using pulse oximetry sensor with manual capillary refill time: clinical pilot study in the emergency department. J Intensive Care. 2019 Nov 27;7:52. doi: 10.1186/s40560-019-0406-0. eCollection 2019.
- Background: PubMed 29846867Shinozaki K, Capilupi MJ, Saeki K, Hirahara H, Horie K, Kobayashi N, Weisner S, Kim J, Lampe JW, Becker LB. Low temperature increases capillary blood refill time following mechanical fingertip compression of healthy volunteers: prospective cohort study. J Clin Monit Comput. 2019 Apr;33(2):259-267. doi: 10.1007/s10877-018-0159-7. Epub 2018 May 30.
- Individual participant dataSharing planned: No
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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
Administrative Director 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 Peripheral Perfusion, 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 5 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: stopped early, as of the sponsor's last update on 27 Dec 2024. 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?
The study was stopped early (reason given: Insufficient enrollment to achieve outcomes). Results are not available in the source record.
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?
AUC of ROC curve for 30 days mortality (time frame: 31 days). 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 NCT04366310, which also lists 11 linked publications.
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 27 Dec 2024.