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

NCT07209956 | Completed

• 1 other identifier: CHUBX 2022/17
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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).

Conditions

Bronchiolitis; Viral

Keywords

acute bronchiolitis; echocardiography; TAPSE; myocardial dysfunction; pulmonary hypertension; PICU

Outcome Measures

Primary Outcomes (1)

• PICU lenght of stay

  The primary outcome will be the PICU length of stay (LOS), in days.

  Upon discharge from intensive care, maximum of 5 months

Secondary Outcomes (4)

• Hospital length of stay (days)

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

• Intubation and ventilation

  Upon discharge from intensive care, maximum of 5 months

• Respiratory support

  Upon discharge from intensive care, maximum of 5 months

• Death

  until his or her death, maximum of 5 months

Study Arms (1)

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.

Procedure: Echocardiographic assessment of TAPSE

Interventions

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.

TAPSE marker

Eligibility Criteria

• Age: 0 Months - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Bordeaux Hospital University

Bordeaux, 3300, France

Location

MeSH Terms

Conditions

Bronchiolitis; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 7, 2025
• Study Start: October 18, 2022
• Primary Completion: October 18, 2022
• Study Completion: January 9, 2023
• Last Updated: October 7, 2025

Record last verified: 2025-09

Locations

FR (1)