Clinical trial NCT03298217: Peak Tidal Inspiratory Flow in Infants With Moderate to Severe Acute Viral Bronchiolitis
Official title: Peak Tidal Inspiratory Flow in Infants With Moderate to Severe Acute Viral Bronchiolitis: a Physiologic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Keywords: Inspiratory flow
High flow nasal cannula, spirometry
spirometry
physiologic study
Bronchiolitis patients sverity score mWCAS/ 3-5.
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-10-02
Enrollment: 50
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Infants up to 6 months old, with AVB according to conventional clinical criteria;
* Admitted to the department of Neonatal and Pediatric Intensive Care at Arnaud de Villeneuve University Hospital in Montpellier (France);
* Supported with HFNC, according to the department's protocol (2 \< m-WCAS \< 5);
* Not requiring immediate intubation for invasive ventilation;
* Signed parental consent.

Exclusion Criteria:

* Infant with heart disease, cystic fibrosis or neuromuscular disorder;
* Infant requiring ventilatory support with nasal continuous positive pressure (nCPAP) or with HFNC and without possibility of weaning, including for a few minutes;
* Intolerance of the spirometry mask.

Primary outcomes:
measure: Measurement of peak or peak inspiration flow (PTIF=peak tidal inspiratory flow)
timeFrame: 1 day but within 24 hours of patient admission
Secondary outcomes:
measure: Proportion of patients with a spontaneous PTIF higher than 2 L/kg/min
timeFrame: 1 day but within 24 hours of patient admission
measure: Correlation between PTIF and Silverman score
timeFrame: 1 day but within 24 hours of patient admission
measure: Correlation between PTIF and modified Wood's clinical asthma score
timeFrame: 1 day but within 24 hours of patient admission
measure: Correlation between PTIF and respiratory rate (FR)
timeFrame: 1 day but within 24 hours of patient admission
measure: Correlation between PTIF and carbon dioxide (CO2)
timeFrame: 1 day
measure: Duration of hospitalization
timeFrame: 1 day at the end of the hospitalization
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Christophe MILESI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: