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NCT Number: NCT07209956

Etude PROTECT : Prognostic Role of Tapse Evaluation in Children's bronchioliTis

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).

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Key information

Conditions

Bronchiolitis Bronchial Diseases Bronchitis Cardiovascular Diseases Hypertension Hypertension, Pulmonary Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections Vascular Diseases Viral

Age range

0 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bordeaux Hospital University

Bordeaux, 3300, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Patients suffering from Chronic Heart Disease, chronic respiratory disease (including bronchopulmonary dysplasia and excluding asthma)
  • Impairment of echocardiographic window

Treatment and study plan

Echocardiographic assessment of TAPSE

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Hospital length of stay (days)

    Time frame: discharge from the hospital, or until his or her death, maximmum of 5 months

    Hospital length of stay (days)

  2. Intubation and ventilation

    Time frame: Upon discharge from intensive care, maximum of 5 months

    Need for intubation and invasive ventilation during the PICU stay

  3. Respiratory support

    Time frame: Upon discharge from intensive care, maximum of 5 months

    Length of respiratory support (days)

  4. Death

    Time frame: until his or her death, maximum of 5 months

    Patient death

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study 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

Acronym: PROTECT

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Oct 7, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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