Near-infrared Vision for Microcirculatory Status (NVIM)

Machine Learning-Based Near-infrared Vision to Evaluate the Microcirculatory of Critical Ill Patients: A Prospective Observational Study

The investigators aimed to combine the image of near-infrared vision and machine learning method to evaluate the microcirculatory status of critical ill patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Machine Learning; Near-infrared Vision; Microcirculatory Status
• Intervention / Treatment: Diagnostic test: Near-infrared Vision Photograph

Detailed Description

The heat distribution of body is determined by the circulatory status. The investigators plan to the near-infrared vision to collect heat distribution information of limbs. Then, the machine learning method will be performed to recognize the subtle differences between images. Due to lack of golden standard of microcirculatory status, indirect parameters (such as lactate clearance, capillary refill time) and clinical outcomes will be recorded to evaluate the performance of maching learning model.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

General critical ill patients who required evaluation of perfussion.

Description

Inclusion Criteria:

• Age≥18 years;
• Patients who were transfered to our ICU.

Exclusion Criteria:

• Abnormalities of lower limbs arteries

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital mortality	The rate of patients who died during hospital stay.	From date of admission to our ICU until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 2 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lacteta clearance rate	The percent change of lactate between lactates measured in two time points. This parameter was usually used to guide resuscitation in septic shock.	When the near-infrared image is taken for a patient, the blood gas analysis will be performed immediately to get the value of lactate. After 2-hours, another blood gas analysis will be conducted to get the second value of lactete.
Capillary refill time (CRT)	A noninvasive parameter of peripheral perfusion status. CRT was measured by applying firm pressure to the ventral surface of the right index finger distal phalanx with a glass microscope slide. The pressure was increased until the skin was blank and then maintained for 10 seconds. The time for return of the normal skin color was registered with a chronometer, and a refill time greater than 3 seconds was defined as abnormal.(Hernández 2019.JAMA)	When the near-infrared image is taken for a patient, the capillary refill time will be measured immediately.

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 17, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: May 16, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: B2020-057R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Our institutional ethics commitee did nor approve to share data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No