Catheter InfectionDeepCathNCT05440396
Identifying Local Signs at the Catheter Insertion Site With Artificial Intelligence
An observational study of Catheter Infection, run by Outcome Rea at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter Infection
- What is being tested?
- Photographs collection phase
- Type of treatment
- Pill or oral medicine
- How many people
- 1,000 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Sep 2022to 31 Dec 2023
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, Puy-de-Dôme, 63000
Bertrand Souweine, bsouweine@chu-clermontferrand.fr
Bertrand Souweine
- Recruiting
CHU Grenoble Alpes
Grenoble, Isère, 38000
Carole Schwebel, (+33)476768779, cschwebel@chu-grenoble.fr
Carole Schwebel
- Recruiting
Hôpital Bichat - Claude-Bernard
Paris, Île-de-France Region, 75018
Jean-François Timsit, jean-francois.timsit@bch.aphp.fr
Jean-François Timsit
- Recruiting
Réseau RéPIAS SPIADI
Tours
Nathalie VAN DER MEE, Pr, n.vandermee@chu-tours.fr
About this study
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
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.
- Conditions
- Catheter Infection
- Being tested
- Photographs collection phase
- Keywords
- catheter infection, deep learning, local signs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photographs collection phaseDiagnostic test
Also called Photographs reviewing phase by medical experts, Development/Validation of artificial intelligence algorithm
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Photographs collection phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of correct predictions for redness divided by the total number of predictions
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
The ratio of true positives and total positives predicted:
The precision metric focuses on Type-I errors(FP). A Type-I error occurs when we reject a true null Hypothesis.
Measured: through study completion, an average of 1 year
The number of correct predictions for indurated venous cord divided by the total number of predictions
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.
Measured: through study completion, an average of 1 year
The link between presence of local signs and infection
Measure the correlation between the appearance of the catheter puncture site and the presence of signs consistent with local and systemic infection.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Catheter InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Outcome Rea
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris, National Network Surveillance and Prevention of Infections Associated with Invasive Devices SPIADI, University Hospital, Clermont-Ferrand, University Hospital, Grenoble, UNICANCER, University Grenoble Alps
- Responsible party
- Sponsor
- Investigators
- Jean-François TIMISIT, Pr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440396
- Sponsor's protocol ID
- DeepCath
- Acronym
- DeepCath
- Status last verified
- Oct 2022
- First submitted
- 21 Jun 2022
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 19318651Timsit JF. Diagnosis and prevention of catheter-related infections. Curr Opin Crit Care. 2007 Oct;13(5):563-71. doi: 10.1097/MCC.0b013e3282efa03f.
PubMed 17762237Buetti 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.
PubMed 35624170Blot 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.
PubMed 35249794Buetti 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.
PubMed 34920150Buetti 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.
PubMed 35659775
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05440396
- Acronym / sponsor ID
- DeepCath / DeepCath
- Conditions
- Catheter Infection
- Keywords
- catheter infection, deep learning, local signs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Outcome ReaUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris, National Network Surveillance and Prevention of Infections Associated with Invasive Devices SPIADI, University Hospital, Clermont-Ferrand, University Hospital, Grenoble, UNICANCER, University Grenoble Alps
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Diagnostic Test: Photographs collection phasePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photographs collection phaseAlso: Photographs reviewing phase by medical experts, Development/Validation of artificial intelligence algorithmThree 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. | Diagnostic test | Patient |
Primary outcome
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.
3 secondary outcomes
The ratio of true positives and total positives predicted:
Time frame: 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
The link between presence of local signs and infection
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Results publication: PubMed 19318651Timsit 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.
- Results publication: PubMed 17762237Timsit JF. Diagnosis and prevention of catheter-related infections. Curr Opin Crit Care. 2007 Oct;13(5):563-71. doi: 10.1097/MCC.0b013e3282efa03f.
- Results publication: PubMed 35624170Buetti 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.
- Results publication: PubMed 35249794Blot 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.
- Results publication: PubMed 34920150Buetti 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.
- Results publication: PubMed 35659775Buetti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-François TIMISIT, Pr principal investigator
Assistance Publique - Hôpitaux de Paris
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Catheter Infection, run by Outcome Rea at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-François TIMSIT, Pr (+33140257703, jean-francois.timsit@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of correct predictions for redness divided by the total number of predictions (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05440396, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.