Clinical trial NCT05440396: Identifying Local Signs at the Catheter Insertion Site With Artificial Intelligence
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Catheter Infection
Keywords: catheter infection
deep learning
local signs
Lead sponsor: Outcome Rea
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
name: National Network Surveillance and Prevention of Infections Associated with Invasive Devices SPIADI
name: University Hospital, Clermont-Ferrand
name: University Hospital, Grenoble
name: UNICANCER
name: University Grenoble Alps
First posted: 2022-06-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The number of correct predictions for redness divided by the total number of predictions
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: The ratio of true positives and total positives predicted:
timeFrame: through study completion, an average of 1 year
measure: The number of correct predictions for indurated venous cord divided by the total number of predictions
timeFrame: through study completion, an average of 1 year
measure: The link between presence of local signs and infection
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Bichat - Claude-Bernard
state: Ile De France
city: Grenoble
country: France
facility: CHU Grenoble Alpes
state: Isère
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
state: Puy-de-Dôme
city: Tours
country: France
facility: Réseau RéPIAS SPIADI
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-François TIMISIT, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Timsit JF, Schwebel C, Bouadma L, Geffroy A, Garrouste-Orgeas M, Pease S, Herault MC, Haouache H, Calvino-Gunther S, Gestin B, Armand-Lefevre L, Leflon V, Chaplain C, Benali A, Francais A, Adrie C, Zahar JR, Thuong M, Arrault X, Croize J, Lucet JC; Dressing Study Group. Chlorhexidine-impregnated sponges and less frequent dressing changes for prevention of catheter-related infections in critically ill adults: a randomized controlled trial. JAMA. 2009 Mar 25;301(12):1231-41. doi: 10.1001/jama.2009.376.
citation: Timsit JF. Diagnosis and prevention of catheter-related infections. Curr Opin Crit Care. 2007 Oct;13(5):563-71. doi: 10.1097/MCC.0b013e3282efa03f.
citation: Buetti N, Rickard CM, Timsit JF. Catheter dressings. Intensive Care Med. 2022 Aug;48(8):1066-1068. doi: 10.1007/s00134-022-06734-w. Epub 2022 May 27. No abstract available.
citation: Blot S, Ruppe E, Harbarth S, Asehnoune K, Poulakou G, Luyt CE, Rello J, Klompas M, Depuydt P, Eckmann C, Martin-Loeches I, Povoa P, Bouadma L, Timsit JF, Zahar JR. Healthcare-associated infections in adult intensive care unit patients: Changes in epidemiology, diagnosis, prevention and contributions of new technologies. Intensive Crit Care Nurs. 2022 Jun;70:103227. doi: 10.1016/j.iccn.2022.103227. Epub 2022 Mar 3.
citation: Buetti N, Mermel LA, Timsit JF. Routine catheter-tip cultures for assessing catheter-related bloodstream infections in randomised-controlled trials. Anaesth Crit Care Pain Med. 2022 Feb;41(1):101006. doi: 10.1016/j.accpm.2021.101006. Epub 2021 Dec 14. No abstract available.
citation: Buetti N, Abbas M, Pittet D, Chraiti MN, Sauvan V, De Kraker MEA, Boisson M, Teixeira D, Zingg W, Harbarth S. Lower risk of peripheral venous catheter-related bloodstream infection by hand insertion. Antimicrob Resist Infect Control. 2022 Jun 3;11(1):80. doi: 10.1186/s13756-022-01117-8.