Skip to main content
OpenTrials
Completed

NCT Number: NCT03298217

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

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

    Time frame: 1 day but within 24 hours of patient admission

    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.

Secondary outcomes

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

    Time frame: 1 day but within 24 hours of patient admission

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

  2. Correlation between PTIF and Silverman score

    Time frame: 1 day but within 24 hours of patient admission

    Correlation between PTIF (l/kg/min) and Silverman score (0 to 10)

  3. Correlation between PTIF and modified Wood's clinical asthma score

    Time frame: 1 day but within 24 hours of patient admission

    Correlation between PTIF (l/kg/min) and modified Wood's clinical asthma score(m-WCAS) (0 to 10)

    • Correlation between PTIF (l/kg/min) and respiratory rate (FR) (breath/min)
    • Correlation between PTIF (l/kg/min) and carbon dioxide (CO2) (mmHg) measured by capillary blood gases or with transcutaneous electrodes, duration of hospitalization

  4. Correlation between PTIF and respiratory rate (FR)

    Time frame: 1 day but within 24 hours of patient admission

    Correlation between PTIF (l/kg/min) and respiratory rate (FR) (breath/min)

  5. Correlation between PTIF and carbon dioxide (CO2)

    Time frame: 1 day

    Correlation between PTIF (l/kg/min) and carbon dioxide (CO2) (mmHg) measured by capillary blood gases or with transcutaneous electrodes

  6. Duration of hospitalization

    Time frame: 1 day at the end of the hospitalization

    Duration of hospitalization

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Peak Tidal Inspiratory Flow in Infants With Moderate to Severe Acute Viral Bronchiolitis: a Physiologic Study

Acronym: DEBIB

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 2, 2017
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.