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

NCT ID: NCT07209956

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-18
• Study Completion Date: 2023-01-09

Brief 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).

Detailed Description

During the winter season, acute bronchiolitis is the leading cause of PICU 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

TAPSE marker

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.

Group Type: EXPERIMENTAL

Echocardiographic assessment of TAPSE

Intervention Type: 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.

Interventions

Echocardiographic assessment of TAPSE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 0 Months
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bordeaux Hospital University

Bordeaux, , France

Countries

France

Other Identifiers

CHUBX 2022/17

Identifier Type: -

Identifier Source: org_study_id