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Capillary Refill Index with Rewarming

NCT ID: NCT04366310

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-16

Study Completion Date

2023-03-01

Brief Summary

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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

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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

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Peripheral Perfusion

Keywords

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capillary refill time peripheral perfusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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capillary refill index (CRI)

a waveform analysis method using a pulse oximeter to assess peripheral perfusion

capillary refill index

Intervention Type DEVICE

a waveform analysis method using a pulse oximeter to assess peripheral perfusion

rewarming

Intervention Type PROCEDURE

warming fingertip skin temperature using an instant hot pack

Interventions

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capillary refill index

a waveform analysis method using a pulse oximeter to assess peripheral perfusion

Intervention Type DEVICE

rewarming

warming fingertip skin temperature using an instant hot pack

Intervention Type PROCEDURE

Other Intervention Names

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CRI

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older;
* Admitted to any ICU of North Shore University Hospital (NSUH) within 24 hours

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nihon Kohden

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timmy Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Administrative Director Clinical Research Emergency Medicine, Northwell Health

Locations

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North Shore University Hospital

Manhasset, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 3415066 (View on PubMed)

Lima 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.

Reference Type BACKGROUND
PMID: 19237899 (View on PubMed)

Ait-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.

Reference Type BACKGROUND
PMID: 24811942 (View on PubMed)

van 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.

Reference Type BACKGROUND
PMID: 24894892 (View on PubMed)

Alsma 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.

Reference Type BACKGROUND
PMID: 27940191 (View on PubMed)

Pickard 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.

Reference Type BACKGROUND
PMID: 21519051 (View on PubMed)

Shinozaki 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.

Reference Type BACKGROUND
PMID: 31060576 (View on PubMed)

Shinozaki 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.

Reference Type BACKGROUND
PMID: 31916222 (View on PubMed)

Shinozaki 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.

Reference Type BACKGROUND
PMID: 29678295 (View on PubMed)

Shinozaki 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.

Reference Type BACKGROUND
PMID: 31798887 (View on PubMed)

Shinozaki 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.

Reference Type BACKGROUND
PMID: 29846867 (View on PubMed)

Other Identifiers

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20-0310

Identifier Type: OTHER

Identifier Source: secondary_id

A960-055244

Identifier Type: -

Identifier Source: org_study_id