Identifying Local Signs at the Catheter Insertion Site With Artificial Intelligence (DeepCath)

October 24, 2022 updated by: Outcome Rea

Development of an Artificial Intelligence Model of Image Recognition Through Images of Intravascular Catheters From Inpatients and Outpatients to Identify the Presence of Local Signs Associated With Infection

Deepcath is the first step to the introduction of artificial intelligence in catheter care. A better use of visualisation of catheter exit site should be used not only by the HCWs but also by the patients and their family.

A deep learning system able to detect visual abnormalities of the catheter exit site will be an helpful tools to develop a continuous follow-up of intravascular catheters.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Ile De France
      • Paris, Ile De France, France, 75018
        • Recruiting
        • Hôpital Bichat - Claude-Bernard
        • Contact:
        • Principal Investigator:
          • Jean-François Timsit
    • Isère
      • Grenoble, Isère, France, 38000
        • Recruiting
        • Chu Grenoble Alpes
        • Contact:
        • Principal Investigator:
          • Carole SCHWEBEL
    • Puy-de-Dôme

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Patients will be recruited independently in each of the centers participating in the study, according to the specific organization of each service (hospital and home). Patients will be selected based on the study inclusion/non-inclusion criteria. The included patients will receive oral information about the study. The informed consent will be obtained before any investigation.

Description

Inclusion Criteria:

Patients over 18 years of age Patients with one or more implanted central venous, midline, piCCline, arterial, or peripheral catheters.

Patient and/or trusted person and/or family who have verbally stated their non-objection to the study Patient affiliated or beneficiary of a social security plan

Exclusion Criteria:

Patients presenting a peripheral identification sign close to the catheter insertion point cannot be masked when the photograph is taken. Thus, jewelry, clothing, tattoos, scars, and birthmarks are identifying features.

Patients whose catheter insertion point is not visible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient

Patients will be recruited independently in each of the centers participating in the study, according to the specific organization of each service (hospital and home). Patients will be selected based on the study inclusion/non-inclusion criteria. The included patients will receive oral information about the study. The informed consent will be obtained before any investigation.

Each photograph will focus on the intravascular catheter. The investigators will respect the main non-inclusion criterion: not to show any peripheral identification sign close to the insertion point of the catheter that cannot be masked when the photograph is taken. In this context, jewellery, clothing, tattoos, scars, and birthmarks represent identifying features. Individual access accounts with secure, randomly generated passwords will be provided to investigators.

The photographs will be anonymous, and any identification of the person concerned will be impossible.
Diagnostic test: Photographs collection phase

Three medical experts have been selected to review the photo collected. Each expert medical assesses the presence of local signs of infection on the photographs by annotating them directly via a dedicated software. They will annotate local signs: redness, perfusion extravasation, necrosis, hematoma, edema, non-purulent discharge, and purulent discharge.

A convolutional neural network model will determine the probability of local sign presence. Each picture will be annotated to determine the main characteristics of the catheter. A dataset preparation with photo cropping will be performed for modelling.

Other Names:
  • Photographs reviewing phase by medical experts
  • Development/Validation of artificial intelligence algorithm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of correct predictions for redness divided by the total number of predictions
Time Frame: through study completion, an average of 1 year
Overall classification accuracy of the learning model compared to the assessment of three independent medical experts on the detection of the presence of redness greater than or equal to 5 mm at the catheter insertion site.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The ratio of true positives and total positives predicted:
Time Frame: through study completion, an average of 1 year
The precision metric focuses on Type-I errors(FP). A Type-I error occurs when we reject a true null Hypothesis.
through study completion, an average of 1 year
The number of correct predictions for indurated venous cord divided by the total number of predictions
Time Frame: through study completion, an average of 1 year
Evaluate, on the basis of images of peripheral catheter insertion sites, the reliability of the learning model on the assessment of the presence of indurated venous cord.
through study completion, an average of 1 year
The link between presence of local signs and infection
Time Frame: through study completion, an average of 1 year
Measure the correlation between the appearance of the catheter puncture site and the presence of signs consistent with local and systemic infection.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Outcome Rea

Collaborators

Assistance Publique - Hôpitaux de Paris
University Hospital, Clermont-Ferrand
University Hospital, Grenoble
UNICANCER
Université Grenoble-Alpes
National Network Surveillance and Prevention of Infections Associated with Invasive Devices SPIADI

Investigators

  • Principal Investigator: Jean-François TIMISIT, Pr, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2022

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

June 21, 2022

First Submitted That Met QC Criteria

June 27, 2022

First Posted (ACTUAL)

June 30, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 25, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DeepCath

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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