Capillary Refill Index with Rewarming

NCT04366310 | Terminated FDA Device

• 2 other identifiers: A960-05524420-0310
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Peripheral Perfusion

Keywords

capillary refill time; peripheral perfusion

Outcome Measures

Primary Outcomes (1)

• 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.

  31 days

Study Arms (1)

capillary refill index (CRI)

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

Device: capillary refill index; Procedure: rewarming

Interventions

capillary refill index DEVICE

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

Also known as: CRI

capillary refill index (CRI)

rewarming PROCEDURE

warming fingertip skin temperature using an instant hot pack

capillary refill index (CRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult intensive care unit (ICU) patients (both males and females without regards to ethnic and racial backgrounds)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nihon Kohden: lead

Study Sites (1)

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Related Publications (11)

• 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.

  PMID: 3415066 BACKGROUND

• 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.

  PMID: 19237899 BACKGROUND

• 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.

  PMID: 24811942 BACKGROUND

• 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.

  PMID: 24894892 BACKGROUND

• 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.

  PMID: 27940191 BACKGROUND

• 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.

  PMID: 21519051 BACKGROUND

• 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.

  PMID: 31060576 BACKGROUND

• 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.

  PMID: 31916222 BACKGROUND

• 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.

  PMID: 29678295 BACKGROUND

• 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.

  PMID: 31798887 BACKGROUND

• 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.

  PMID: 29846867 BACKGROUND

MeSH Terms

Interventions

Rewarming

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Timmy Li, PhD

  Administrative Director Clinical Research Emergency Medicine, Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 28, 2020
• Study Start: November 16, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2023
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)