BronchiolitisPROTECTNCT07209956
Etude PROTECT : Prognostic Role of Tapse Evaluation in Children's bronchioliTis
A study testing Echocardiographic assessment of TAPSE in people with Bronchiolitis and Viral, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
In this prospective study, we aim to evaluate the association between an echocardiographic marker of right ventricular systolic function, the TAPSE (Tricuspid Annular Plane Systolic Excursion), and poor outcome in patients admitted to Pediatric Intensive Care Unit (PICU) for Acute Bronchiolitis (AB). Read more about this study
- Who is it for?
- Ages 0 months to 2 years
- Conditions the study is for
- Bronchiolitis, Viral
- What is being tested?
- Echocardiographic assessment of TAPSE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 18 Oct 2022to 9 Jan 2023
- 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 0 months to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants under the age of 2
- Admitted to PICU with diagnosis of acute bronchiolitis (according to AAP criteria)
- Within the first 36h of PICU stay
Who cannot join
- Patients suffering from Chronic Heart Disease, chronic respiratory disease (including bronchopulmonary dysplasia and excluding asthma)
- Impairment of echocardiographic window
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation de la Valeur Pronostique du TAPSE (Tricuspid Plane Annular Systolic Excursion) Dans la Bronchiolite aigüe sévère Chez l'Enfant hospitalisé en réanimation ou Soins Continus pédiatriques
In this prospective study, we aim to evaluate the association between an echocardiographic marker of right ventricular systolic function, the TAPSE (Tricuspid Annular Plane Systolic Excursion), and poor outcome in patients admitted to Pediatric Intensive Care Unit (PICU) for Acute Bronchiolitis (AB).
Read the detailed description
During the winter season, acute bronchiolitis is the leading cause of PICU (Pediatric Intensive Care Unit )admissions among children under the age of 2 years old, worldwide. Indeed, it is estimated that 10% of children hospitalized for AB will require intensive care, with lengths of stay ranging from several days to several weeks. It is therefore crucial to identify those patients at highest risk of severe disease in order to provide the best management options and potentially decrease morbidity. Recently, the prognostic value of the TAPSE (Tricuspid Annular Plane Systolic Excursion), a marker of right ventricle systolic dysfunction, has been demonstrated in adults suffering from SARS-Cov-2 pneumoniae. Indeed, several studies identify a decrease in TAPSE as a marker associated with an increased mortality among patients hospitalized in ICU with SARS Cov-2 pneumoniae. Moreover, some pediatric studies suggest that pulmonary pressures and right ventricular function could be impaired in AB, and thus associated with a less favorable outcome. None of these studies has specifically investigated the TAPSE as a predictor of severity in AB.
To address this question, we plan to conduct a prospective study among children admitted to PICU with AB, and evaluate the association between the TAPSE value at PICU admission, and the PICU length of stay. Patients included in the study, will undergo a systematic echocardiographic assessment with measurement of the TAPSE, within the first 36 hours of admission in PICU for AB. They will then be followed until discharge of hospital, or the occurrence of death, or until the end of the inclusion period. If, during the follow-up period, intubation for invasive ventilation is required, a second echocardiographic assessment will be performed, with measurement of the TAPSE, in order to compare it to the initial value, in secondary analysis for exploratory purposes.
- Conditions
- Bronchiolitis, Viral
- Being tested
- Echocardiographic assessment of TAPSE
- Keywords
- acute bronchiolitis, echocardiography, TAPSE, myocardial dysfunction, pulmonary hypertension, PICU
- Medical subject headings
- Bronchiolitis, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiographic assessment of TAPSEProcedure or surgery
Non interventional study (study of a prognostic factor). The study procedure is the echocardiographic assessment of TAPSE at every admission in PICU for acute bronchiolitis.
Transthoracic echocardiography is a non invasive, non radiative examination, that is usually performed at every admission in PICU, however not mandatory. Inclusion in the study will lead to a systematic echocardiographic assessment at admission, potentially adding this examination to the patient's course.
As transthoracic echocardiography is systematically monitored in intubated children, no additional examination will be necessary for those requiring invasive mechanical ventilation.
| Study group | Role | What they receive |
|---|---|---|
| TAPSE marker | Experimental | At every admission in PICU for acute bronchiolitis, a screening for inclusion and exclusion factors will be carried out by an investigator. If the patient is included in the study, an echocardiographic assessment with measurement of the TAPSE will be performed, within the 36h following admission. The patient will then be followed until discharge of hospital, or death, or the end of the inclusion period. We will study the association between the TAPSE value at admission, and the PICU length of stay, in order to determine its prognostic role in severe acute bronchiolitis.
If, during the follow-up period, intubation for invasive ventilation is required, a second echocardiographic assessment will be performed, and the second TAPSE value will be compared to the first one, for exploratory purposes on cardiopulmonary interactions. Receives: Procedure: Echocardiographic assessment of TAPSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
PICU lenght of stay
The primary outcome will be the PICU length of stay (LOS), in days.
Measured: Upon discharge from intensive care, maximum of 5 months
Secondary outcomes (4)
Hospital length of stay (days)
Hospital length of stay (days)
Measured: discharge from the hospital, or until his or her death, maximmum of 5 months
Intubation and ventilation
Need for intubation and invasive ventilation during the PICU stay
Measured: Upon discharge from intensive care, maximum of 5 months
Respiratory support
Length of respiratory support (days)
Measured: Upon discharge from intensive care, maximum of 5 months
Death
Patient death
Measured: until his or her death, maximum of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start18 Oct 2022
- Primary completion18 Oct 2022
- Study completion9 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209956
- Sponsor's protocol ID
- CHUBX 2022/17
- Other IDs
- 2022-A01867-36
- Acronym
- PROTECT
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 22 May 2026
- 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation de la Valeur Pronostique du TAPSE (Tricuspid Plane Annular Systolic Excursion) Dans la Bronchiolite aigüe sévère Chez l'Enfant hospitalisé en réanimation ou Soins Continus pédiatriques
- ClinicalTrials.gov ID
- NCT07209956
- Acronym / sponsor ID
- PROTECT / CHUBX 2022/17
- Conditions
- Bronchiolitis, Viral
- Keywords
- acute bronchiolitis, echocardiography, TAPSE, myocardial dysfunction, pulmonary hypertension, PICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 18 Oct 2022 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 7 Oct 2025 (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.
In this prospective study, we aim to evaluate the association between an echocardiographic marker of right ventricular systolic function, the TAPSE (Tricuspid Annular Plane Systolic Excursion), and poor outcome in patients admitted to Pediatric Intensive Care Unit (PICU) for Acute Bronchiolitis (AB).
Detailed description
During the winter season, acute bronchiolitis is the leading cause of PICU (Pediatric Intensive Care Unit )admissions among children under the age of 2 years old, worldwide. Indeed, it is estimated that 10% of children hospitalized for AB will require intensive care, with lengths of stay ranging from several days to several weeks. It is therefore crucial to identify those patients at highest risk of severe disease in order to provide the best management options and potentially decrease morbidity. Recently, the prognostic value of the TAPSE (Tricuspid Annular Plane Systolic Excursion), a marker of right ventricle systolic dysfunction, has been demonstrated in adults suffering from SARS-Cov-2 pneumoniae. Indeed, several studies identify a decrease in TAPSE as a marker associated with an increased mortality among patients hospitalized in ICU with SARS Cov-2 pneumoniae. Moreover, some pediatric studies suggest that pulmonary pressures and right ventricular function could be impaired in AB, and thus associated with a less favorable outcome. None of these studies has specifically investigated the TAPSE as a predictor of severity in AB.
To address this question, we plan to conduct a prospective study among children admitted to PICU with AB, and evaluate the association between the TAPSE value at PICU admission, and the PICU length of stay. Patients included in the study, will undergo a systematic echocardiographic assessment with measurement of the TAPSE, within the first 36 hours of admission in PICU for AB. They will then be followed until discharge of hospital, or the occurrence of death, or until the end of the inclusion period. If, during the follow-up period, intubation for invasive ventilation is required, a second echocardiographic assessment will be performed, with measurement of the TAPSE, in order to compare it to the initial value, in secondary analysis for exploratory purposes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAPSE marker | Experimental | Procedure: Echocardiographic assessment of TAPSEAt every admission in PICU for acute bronchiolitis, a screening for inclusion and exclusion factors will be carried out by an investigator. If the patient is included in the study, an echocardiographic assessment with measurement of the TAPSE will be performed, within the 36h following admission. The patient will then be followed until discharge of hospital, or death, or the end of the inclusion period. We will study the association between the TAPSE value at admission, and the PICU length of stay, in order to determine its prognostic role in severe acute bronchiolitis. If, during the follow-up period, intubation for invasive ventilation is required, a second echocardiographic assessment will be performed, and the second TAPSE value will be compared to the first one, for exploratory purposes on cardiopulmonary interactions. |
Who may qualify
- Ages
- 0 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants under the age of 2
- Admitted to PICU with diagnosis of acute bronchiolitis (according to AAP criteria)
- Within the first 36h of PICU stay
Key exclusion criteria (2 listed)
- Patients suffering from Chronic Heart Disease, chronic respiratory disease (including bronchopulmonary dysplasia and excluding asthma)
- Impairment of echocardiographic window
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 |
|---|---|---|
| Echocardiographic assessment of TAPSENon interventional study (study of a prognostic factor). The study procedure is the echocardiographic assessment of TAPSE at every admission in PICU for acute bronchiolitis. Transthoracic echocardiography is a non invasive, non radiative examination, that is usually performed at every admission in PICU, however not mandatory. Inclusion in the study will lead to a systematic echocardiographic assessment at admission, potentially adding this examination to the patient's course. As transthoracic echocardiography is systematically monitored in intubated children, no additional examination will be necessary for those requiring invasive mechanical ventilation. | Procedure or surgery | TAPSE marker |
Primary outcome
PICU lenght of stay
Time frame: Upon discharge from intensive care, maximum of 5 months
The primary outcome will be the PICU length of stay (LOS), in days.
4 secondary outcomes
Hospital length of stay (days)
Time frame: discharge from the hospital, or until his or her death, maximmum of 5 months
Intubation and ventilation
Time frame: Upon discharge from intensive care, maximum of 5 months
Respiratory support
Time frame: Upon discharge from intensive care, maximum of 5 months
Death
Time frame: until his or her death, maximum of 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echocardiographic assessment of TAPSE in people with Bronchiolitis and Viral, run by University Hospital, Bordeaux 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 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: finished, as of the sponsor's last update on 22 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PICU lenght of stay (time frame: Upon discharge from intensive care, maximum of 5 months). 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 22 May 2026.