Peak Tidal Inspiratory Flow in Infants With Moderate to Severe Acute Viral

Status Completed

Clinical Trial Summary

This aim of this study is to measure the peak tidal inspiratory flow (PTIF), using spirometry, in young infants with moderate to severe acute viral bronchiolitis (AVB). PTIF is important to consider for the management of AVB with High Flow Nasal Cannulae (HFNC). Indeed, efficiency with HFNC is optimal provided that the settled flow is equal or higher than the patient's PTIF. However, PTIF values in infants with AVB have never been determined.

Clinical Trial Description

HFNC allows the administration of a heated and humidified mixture of air and oxygen at high flows. This device has been widely adopted in pediatric intensive care units (PICUs) and for interhospital transport of critically ill children, as the system is easily set up and is well tolerated by patients. In the context of AVB, retrospective audits and observational studies have suggested promising outcomes on both physiological and clinical variables. However, in less than 6 months old infants with moderate to severe AVB, the failure rate with this device - defined as worsening of respiratory failure or the occurrence of discomfort or severe apnea - remains high, from 30% to 50% in key studies. HFNC flow setting remains empiric, 2 L/kg/min being used by most teams. A potential explanation for this high failure rate is that the flow usually used is lower than the patient's inspiratory flow. The aim of this study is to determine peak tidal inspiratory flow (PTIF) values in infants up to 6 months old with moderate to severe AVB. PTIF will be evaluated with a spirometer connected to a face mask during 20 cycles of spontaneous ventilation. The measurements will be performed within the first 24 hours of hospitalization in the department of Neonatal and Pediatric Intensive Care of Arnaud de Villeneuve University Hospital at Montpellier (France). Statistical analysis Relation between the DIP and Silverman score, mWCAS, RR, LOS will be expressed with parametric and non-parametric correlation coefficients according to the distribution of the data. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03298217
Study type	Interventional
Source	University Hospital, Montpellier
Contact
Status	Completed
Phase	N/A
Start date	November 21, 2017
Completion date	January 16, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Peak Tidal Inspiratory Flow in Infants With Moderate to Severe Acute Viral Bronchiolitis — DEBIB

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms