NCT04399811

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

May 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 22, 2020

Status Verified

May 1, 2020

Enrollment Period

3.6 years

First QC Date

May 16, 2020

Last Update Submit

May 19, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Lacteta clearance rate

    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)

    When the near-infrared image is taken for a patient, the capillary refill time will be measured immediately.

Interventions

The near-infrared image will be recorded (by a infrared camera connected to a laptop) for each enrolled patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

General critical ill patients who required evaluation of perfussion.

You may qualify if:

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

You may not qualify if:

  • Abnormalities of lower limbs arteries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2020

First Posted

May 22, 2020

Study Start

May 17, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 22, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Our institutional ethics commitee did nor approve to share data.