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

NCT03298217 | Completed

• 1 other identifier: UF9868
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis

Keywords

Inspiratory flow; High flow nasal cannula, spirometry; spirometry; physiologic study; Bronchiolitis patients sverity score mWCAS/ 3-5.

Outcome Measures

Primary Outcomes (1)

• Measurement of peak or peak inspiration flow (PTIF=peak tidal inspiratory flow)

  Measurement of peak or peak inspiratory flow will be performed by spirometry using a spirometer within 24 hours of patient admission. Evaluation will take place within the first 24 hours of hospitalization in the department of Neonatal and Pediatric Intensive Care among patients with moderate to severe AVB. Description: Application of the spirometer for the recording of 20 consecutives spontaneous respiratory cycles for PTIF (l/kg/min) measurements. Primary outcome: average (+/-SD) of 20 consecutives PTIF.

  1 day but within 24 hours of patient admission

Secondary Outcomes (6)

• Proportion of patients with a spontaneous PTIF higher than 2 L/kg/min

  1 day but within 24 hours of patient admission

• Correlation between PTIF and Silverman score

  1 day but within 24 hours of patient admission

• Correlation between PTIF and modified Wood's clinical asthma score

  1 day but within 24 hours of patient admission

• Correlation between PTIF and respiratory rate (FR)

  1 day but within 24 hours of patient admission

• Correlation between PTIF and carbon dioxide (CO2)

  1 day

Study Arms (1)

Bronchiolitis patients sverity

OTHER

In patients with bronchiolitis mWCAS / 3-5 : Measurement of the peak tidal inspiratory flow (PTIF)

Device: Measurement of the peak tidal inspiratory flow (PTIF)

Interventions

Measurement of the peak tidal inspiratory flow (PTIF) DEVICE

In patients with bronchiolitis sverity mWCAS / 3-5 : Nasopharyngeal aspiration and comfortable placement of the infant upon admission; Clinical evaluation: respiratory rate, respiratory distress scores rating (Silverman and m-WCAS); If the patient is eligible: information and collection of parental consent; If signed parental consent obtained: progressive (on at least 10 min) withdrawal of HFNC support and maintenance if necessary of conventional oxygen therapy (maximum 1 L/min); Application of the spirometer for the recording of 20 consecutive spontaneous respiratory cycles for PTIF measurements; Respiratory support with HFNC; flow adapted to the need of the patients (equal to the measured PTIF).

Bronchiolitis patients sverity

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Christophe MILESI, MD, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: October 2, 2017
• Study Start: November 21, 2017
• Primary Completion: January 16, 2019
• Study Completion: January 16, 2019
• Last Updated: December 27, 2021

Record last verified: 2021-12

Locations

FR (1)