Pediatric Triage in a Pediatric Emergency DepartmentPEWSAPPNCT05363124
Evaluation of Mobile App to Assist in Pediatric Triage
A study testing PEWS calculation by parents using AI-based smartphone app and PEWS calculation by nurse using conventional procedure in people with Pediatric Triage in a Pediatric Emergency Department, run by Fondation Lenval at 1 site in France.
Trial summary
Each ED manages a wide variety of pathologies ranging from a simple general consultation to a life-threatening emergency. Patients require prioritization and triaging as soon as they reach the ED and cannot be seen purely in the order of arrival. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Pediatric Triage in a Pediatric Emergency Department
- What is being tested?
- PEWS calculation by parents using AI-based smartphone app and PEWS calculation by nurse using conventional procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2024to Jun 2025
- Phase
- Interventional
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients under 18
- visited the PED of Lenval Children's Hospital for medical reason
- Parental consent signed
Who cannot join
- Patients visited the PED of Lenval Children's Hospital for a reason other than medical
- A sign (s) of vital distress
- Patients who were called back,
- Patients treated in prehospital care,
- Patients who left without an assigned triage level
- Non-French speaking parents
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpitaux Pédiatriques de Nice CHU-Lenval
Nice
Antoine TRAN, 0492030442, tran.a@pediatrie-chulenval-nice.fr
Dominique DONZEAU, donzeau.d@chu-nice.fr
About this study
Official title: Evaluation of Mobile App to Assist in Pediatric Triage in a Pediatric Emergency Department
Each ED manages a wide variety of pathologies ranging from a simple general consultation to a life-threatening emergency. Patients require prioritization and triaging as soon as they reach the ED and cannot be seen purely in the order of arrival. This triage is mostly carried out by a nurse at the triage zone who must quickly identify high-emergency patients requiring immediate care and organize their care pathway. The triage nurse uses a decision support tool known as a triage tool.
In 2000, the PED of the University Hospital of Nice (France) created a 5-level pediatric triage tool - the pediaTRI - based on clinical items of inspection, interview, and analysis of vital signs.
Read more
In a pediatric ED (PED) setting, a high-level emergency corresponds to a child presenting an immediate life-threatening risk that could lead to cardio-respiratory arrest or a related emergency, and thus requires rapid intervention. These patients, for whom a Level 1 or 2 is usually assigned by commonly used pediatric triage tools, can also be screened using warning scores that are predictive of clinical deterioration within 24 hours after visiting the PED. Among them, the Pediatric Early Warning System (PEWS) system, created in 2001, is considered to be efficient, easy to use, and reliable. According to the literature, the optimal cutoff level to calculate the sensitivity and specificity for admission to an ICU, defined as a high-level emergency, is ≥ 4/9. Vitals signs used to calculate the PEWS are usually collected by the nurse at the triage zone. However, new technology such as mobile application may be also used to capture those vital signs (i-Virtual).
Since the parameters of the PEWS system may be evaluate by parents using the application, the investigators want to analyze their ability to assess the level of severity of their children by scoring PEWS in a pediatric emergency department using the mobile application Caducy® (i-Virtual)
Read the detailed description
The number of visits to emergency departments (ED) has been rising steadily for both adult and pediatric patients over the past decades. resulting in an increase in waiting and care times. Each ED manages a wide variety of pathologies ranging from a simple general consultation to a life-threatening emergency. However, overcrowding in the ED as well as difficulties in monitoring patients waiting for clinical examination, can endanger patient safety. Patients require prioritization and triaging as soon as they reach the ED and cannot be seen purely in the order of arrival. An ideal triage system should be able to identify those who require immediate care (high-level emergency) from those who can wait or those who will not require emergency care (intermediate- to low-level emergency). This triage is mostly carried out by a nurse at the triage zone who must quickly identify high-emergency patients requiring immediate care and organize their care pathway. The triage nurse uses a decision support tool known as a triage tool.
In France, there is no gold standard in pediatric triage and each hospital uses their own "home-made" triage system. In 2000, the PED of the University Hospital of Nice (France) created a 5-level pediatric triage tool - the pediaTRI - based on clinical items of inspection, interview, and analysis of vital signs. In a pediatric ED (PED) setting, a high-level emergency corresponds to a child presenting an immediate life-threatening risk that could lead to cardio-respiratory arrest or a related emergency, and thus requires rapid intervention. These patients, for whom a Level 1 or 2 is usually assigned by commonly used pediatric triage tools, can also be screened using warning scores that are predictive of clinical deterioration within 24 hours after visiting the PED. Among them, the Pediatric Early Warning System (PEWS) system, created in 2001, is considered to be efficient, easy to use, and reliable. The PEWS system is based on three main components each given a 3-point rating as follows: (a) behavior and early signs of shock, recognizable and assessable by the parents; (b) skin tone and capillary refill time to assess the cardiovascular system; (c) and respiratory rate and oxygen dependence to assess the respiratory system. According to the literature, the optimal cutoff level to calculate the sensitivity and specificity for admission to an ICU, defined as a high-level emergency, is ≥ 4/9. Vitals signs used to calculate the PEWS are usually collected by the nurse at the triage zone. However, new technology such as mobile application may be also used to capture those vital signs (i-Virtual).
Since the parameters of the PEWS system may be evaluate by parents using the application, the investigators want to analyze their ability to assess the level of severity of their children by scoring PEWS in our pediatric emergency department using the mobile application Caducy® (i-Virtual).
- Being tested
- PEWS calculation by parents using AI-based smartphone app, PEWS calculation by nurse using conventional procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEWS calculation by parents using AI-based smartphone appOther
After patient registration, the patient will be installed in the nursing office with one of his parents . After screening a potential life-threatening patient for which treatment would be started first of all, the nurse will collect the signed parental consent for participating to the study. Explanations will be given to the parents regarding the use of the application and the way to calculate the PEWS through a very brief and standardized education. Parents should then proceed to the calculation of PEWS, as far as possible before the intervention of the nurse, using the Caducy® appl with a smartphone dedicated to the study .
PEWS calculation by nurse using conventional procedureOther
After patient registration, the patient will be installed in the nursing office with one of his parents . After screening a potential life-threatening patient for which treatment would be started first of all, the nurse will collect the signed parental consent for participating to the study. the nurse proceed to the calculation of PEWS in blind of parents and to triage process by priorityzing patient in 5 level of gravity (from 1-vital emergency to 5-nonurgent patient). If the medical examination was not proceeded directly after the triage process, nurses were asked to proceed a new triage if the optimal delay of the medical examination was passed.
| Study group | Role | What they receive |
|---|---|---|
| PEWS calculation | Experimental | PEWS calculation by parents using AI-based smartphone app PEWS calculation by nurse using conventional procedure Receives: Other: PEWS calculation by parents using AI-based smartphone app; Other: PEWS calculation by nurse using conventional procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Early Warning System (PEWS) calculated by parent using smartphone app
The Pediatric Early Warning System (PEWS) is based on three main components each given a 3-point rating as follows: (a) behavior and early signs of shock, recognizable and assessable by the parents; (b) skin tone and capillary refill time to assess the cardiovascular system; (c) and respiratory rate and oxygen dependence to assess the respiratory system.
the PEWS score is calculated by parent using smartphone app and
According to the score, patients will be classified as follows:
- PEWS [0-2] = no risk
- PEWS[3-4] = moderate risk
- PEWS [5-9] = High risk
Measured: at inclusion
Pediatric Early Warning System calculated by nurse
the PEWS score is calculated by nurse using conventional procedure. he Pediatric Early Warning System (PEWS) is based on three main components each given a 3-point rating as follows: (a) behavior and early signs of shock, recognizable and assessable by the parents; (b) skin tone and capillary refill time to assess the cardiovascular system; (c) and respiratory rate and oxygen dependence to assess the respiratory system.
According to the score, patients will be classified as follows:
- PEWS [0-2] = no risk
- PEWS[3-4] = moderate risk
- PEWS [5-9] = High risk
Measured: at inclusion
Secondary outcomes (9)
PEWS calculated by parents after triage process
PEWS is calculated again by parent using smartphone app If the medical examination was not proceeded directly after the triage process, nurses were asked to proceed a new triage of the patient if the optimal delay of the medical examination was passed. The delays after which a new triage process should be performed by the nurse are defined according to the triage level given by the nurse using the triage tool as follows:
- Level 1: < 5 min
- Level 2: < 20 min
- Level 3: <60 min
- Level 4: <120 min
- Level 5: < 240 min
Measured: until 240 minutes maximum from inclusion
PEWS calculated by nurse after triage process
PEWS is calculated again by nurse If the medical examination was not proceeded directly after the triage process
Measured: until 240 minutes maximum from inclusion
PEWS calculated by doctor
PEWS is calculated by the doctor before the medical examination.
Measured: until 4 hours from inclusion
Agreement between PEWS and final orientation
Agreement (yes/no) between parents using Artificial Intelligent (AI)-based smartphone app and the nurse will be evaluated at the first and the last assessment of PEWS according to the final orientation as follows: discharged, hospitalization, operating room, intensive care unit
Measured: through study completion, an average of 6 months
Agreement between PEWS and group of chief complaint at the triage
Agreement (yes/no) between parents using AI-based smartphone app and the nurse will be evaluated at the first assessment of PEWS according to the group of chief complaint at the triage as follows: medical complaints (categorized as: ear, nose and throat (ENT), pulmonary, cardiovascular, neurology, digestive, urology-nephrology, gynecology, dermatology, endocrinology-metabolism, infectious diseases, rheumatology and pain, hematology, poisoning, and others), surgical complaints (categorized as head and neck trauma, upper and lower limb trauma, trauma of the trunk-pelvis-urogenital apparatus, burns, and others).
Measured: through study completion, an average of 6 months
Agreement between PEWS and diagnosis
Agreement between parents using AI-based smartphone app and the nurse will be evaluated at the first assessment of PEWS according to the group of diagnosis as follows: medical diagnosis and surgical
Measured: through study completion, an average of 6 months
Agreement between PEWS and day period
Agreement (yes/no) between parents using AI-based smartphone app and the nurse will be evaluated at the first assessment of PEWS according to the time when patients have been firstly triaged by the nurse, as follows: opened days and hours (from monday to Friday 08 am to 20pm and Saturday morning 08am to 12pm), on-call (out of the range of time and day defined previously)
Measured: through study completion, an average of 6 months
Agreement between PEWS and patient age
Agreement (yes/no) between parents using AI-based smartphone app and the nurse will be evaluated at the first assessment of PEWS according to the age groups classified as follows: 0 - 27 days, 28 days - 3 months, 3 months - 1 year, 1 - 3 years, 3 - 7 years, 7 - 12 years, and 12 - 18 years
Measured: through study completion, an average of 6 months
parental satisfaction
assessment of parental satisfaction by Likert scale from 1 (totally useless) to 5 (totally useful)
Measured: at the end of patient participation, an average of 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study startSep 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Triage in a Pediatric Emergency DepartmentStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363124
- Sponsor's protocol ID
- 21-HPNCL-05
- Acronym
- PEWSAPP
- Status last verified
- Mar 2023
- First submitted
- 2 May 2022
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mobile App to Assist in Pediatric Triage in a Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT05363124
- Acronym / sponsor ID
- PEWSAPP / 21-HPNCL-05
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 5 May 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.
Each ED manages a wide variety of pathologies ranging from a simple general consultation to a life-threatening emergency. Patients require prioritization and triaging as soon as they reach the ED and cannot be seen purely in the order of arrival. This triage is mostly carried out by a nurse at the triage zone who must quickly identify high-emergency patients requiring immediate care and organize their care pathway. The triage nurse uses a decision support tool known as a triage tool.
In 2000, the PED of the University Hospital of Nice (France) created a 5-level pediatric triage tool - the pediaTRI - based on clinical items of inspection, interview, and analysis of vital signs.
In a pediatric ED (PED) setting, a high-level emergency corresponds to a child presenting an immediate life-threatening risk that could lead to cardio-respiratory arrest or a related emergency, and thus requires rapid intervention. These patients, for whom a Level 1 or 2 is usually assigned by commonly used pediatric triage tools, can also be screened using warning scores that are predictive of clinical deterioration within 24 hours after visiting the PED. Among them, the Pediatric Early Warning System (PEWS) system, created in 2001, is considered to be efficient, easy to use, and reliable. According to the literature, the optimal cutoff level to calculate the sensitivity and specificity for admission to an ICU, defined as a high-level emergency, is ≥ 4/9. Vitals signs used to calculate the PEWS are usually collected by the nurse at the triage zone. However, new technology such as mobile application may be also used to capture those vital signs (i-Virtual).
Since the parameters of the PEWS system may be evaluate by parents using the application, the investigators want to analyze their ability to assess the level of severity of their children by scoring PEWS in a pediatric emergency department using the mobile application Caducy® (i-Virtual)
Detailed description
The number of visits to emergency departments (ED) has been rising steadily for both adult and pediatric patients over the past decades. resulting in an increase in waiting and care times. Each ED manages a wide variety of pathologies ranging from a simple general consultation to a life-threatening emergency. However, overcrowding in the ED as well as difficulties in monitoring patients waiting for clinical examination, can endanger patient safety. Patients require prioritization and triaging as soon as they reach the ED and cannot be seen purely in the order of arrival. An ideal triage system should be able to identify those who require immediate care (high-level emergency) from those who can wait or those who will not require emergency care (intermediate- to low-level emergency). This triage is mostly carried out by a nurse at the triage zone who must quickly identify high-emergency patients requiring immediate care and organize their care pathway. The triage nurse uses a decision support tool known as a triage tool.
In France, there is no gold standard in pediatric triage and each hospital uses their own "home-made" triage system. In 2000, the PED of the University Hospital of Nice (France) created a 5-level pediatric triage tool - the pediaTRI - based on clinical items of inspection, interview, and analysis of vital signs. In a pediatric ED (PED) setting, a high-level emergency corresponds to a child presenting an immediate life-threatening risk that could lead to cardio-respiratory arrest or a related emergency, and thus requires rapid intervention. These patients, for whom a Level 1 or 2 is usually assigned by commonly used pediatric triage tools, can also be screened using warning scores that are predictive of clinical deterioration within 24 hours after visiting the PED. Among them, the Pediatric Early Warning System (PEWS) system, created in 2001, is considered to be efficient, easy to use, and reliable. The PEWS system is based on three main components each given a 3-point rating as follows: (a) behavior and early signs of shock, recognizable and assessable by the parents; (b) skin tone and capillary refill time to assess the cardiovascular system; (c) and respiratory rate and oxygen dependence to assess the respiratory system. According to the literature, the optimal cutoff level to calculate the sensitivity and specificity for admission to an ICU, defined as a high-level emergency, is ≥ 4/9. Vitals signs used to calculate the PEWS are usually collected by the nurse at the triage zone. However, new technology such as mobile application may be also used to capture those vital signs (i-Virtual).
Since the parameters of the PEWS system may be evaluate by parents using the application, the investigators want to analyze their ability to assess the level of severity of their children by scoring PEWS in our pediatric emergency department using the mobile application Caducy® (i-Virtual).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEWS calculation | Experimental | Other: PEWS calculation by parents using AI-based smartphone app, Other: PEWS calculation by nurse using conventional procedurePEWS calculation by parents using AI-based smartphone app PEWS calculation by nurse using conventional procedure |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- patients under 18
- visited the PED of Lenval Children's Hospital for medical reason
- Parental consent signed
Key exclusion criteria (6 listed)
- Patients visited the PED of Lenval Children's Hospital for a reason other than medical
- A sign (s) of vital distress
- Patients who were called back,
- Patients treated in prehospital care,
- Patients who left without an assigned triage level
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 |
|---|---|---|
| PEWS calculation by parents using AI-based smartphone appAfter patient registration, the patient will be installed in the nursing office with one of his parents . After screening a potential life-threatening patient for which treatment would be started first of all, the nurse will collect the signed parental consent for participating to the study. Explanations will be given to the parents regarding the use of the application and the way to calculate the PEWS through a very brief and standardized education. Parents should then proceed to the calculation of PEWS, as far as possible before the intervention of the nurse, using the Caducy® appl with a smartphone dedicated to the study . | Other | PEWS calculation |
| PEWS calculation by nurse using conventional procedureAfter patient registration, the patient will be installed in the nursing office with one of his parents . After screening a potential life-threatening patient for which treatment would be started first of all, the nurse will collect the signed parental consent for participating to the study. the nurse proceed to the calculation of PEWS in blind of parents and to triage process by priorityzing patient in 5 level of gravity (from 1-vital emergency to 5-nonurgent patient). If the medical examination was not proceeded directly after the triage process, nurses were asked to proceed a new triage if the optimal delay of the medical examination was passed. | Other | PEWS calculation |
Primary outcome
Pediatric Early Warning System (PEWS) calculated by parent using smartphone app
Time frame: at inclusion
The Pediatric Early Warning System (PEWS) is based on three main components each given a 3-point rating as follows: (a) behavior and early signs of shock, recognizable and assessable by the parents; (b) skin tone and capillary refill time to assess the cardiovascular system; (c) and respiratory rate and oxygen dependence to assess the respiratory system. the PEWS score is calculated by parent using smartphone app and According to the score, patients will be classified as follows: * PEWS [0-2] = no risk * PEWS[3-4] = moderate risk * PEWS [5-9] = High risk
Pediatric Early Warning System calculated by nurse
Time frame: at inclusion
the PEWS score is calculated by nurse using conventional procedure. he Pediatric Early Warning System (PEWS) is based on three main components each given a 3-point rating as follows: (a) behavior and early signs of shock, recognizable and assessable by the parents; (b) skin tone and capillary refill time to assess the cardiovascular system; (c) and respiratory rate and oxygen dependence to assess the respiratory system. According to the score, patients will be classified as follows: * PEWS [0-2] = no risk * PEWS[3-4] = moderate risk * PEWS [5-9] = High risk
9 secondary outcomes
PEWS calculated by parents after triage process
Time frame: until 240 minutes maximum from inclusion
PEWS calculated by nurse after triage process
Time frame: until 240 minutes maximum from inclusion
PEWS calculated by doctor
Time frame: until 4 hours from inclusion
Agreement between PEWS and final orientation
Time frame: through study completion, an average of 6 months
Agreement between PEWS and group of chief complaint at the triage
Time frame: through study completion, an average of 6 months
Agreement between PEWS and diagnosis
Time frame: through study completion, an average of 6 months
Agreement between PEWS and day period
Time frame: through study completion, an average of 6 months
Agreement between PEWS and patient age
Time frame: through study completion, an average of 6 months
parental satisfaction
Time frame: at the end of patient participation, an average of 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEWS calculation by parents using AI-based smartphone app and PEWS calculation by nurse using conventional procedure in people with Pediatric Triage in a Pediatric Emergency Department, run by Fondation Lenval at 1 site 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 3 inclusion and 6 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 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Antoine TRAN, MD (0492030442 ext. +33, tran.a@pediatrie-chulenval-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Early Warning System (PEWS) calculated by parent using smartphone app (time frame: at inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2023.