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

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

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.

Study Overview

• Status: Completed
• Conditions: Bronchiolitis
• Intervention / Treatment: Device: Measurement of the peak tidal inspiratory flow (PTIF)

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with a spontaneous PTIF higher than 2 L/kg/min	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	Correlation between PTIF (l/kg/min) and Silverman score (0 to 10)	1 day but within 24 hours of patient admission
Correlation between PTIF and modified Wood's clinical asthma score	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	1 day but within 24 hours of patient admission
Correlation between PTIF and respiratory rate (FR)	Correlation between PTIF (l/kg/min) and respiratory rate (FR) (breath/min)	1 day but within 24 hours of patient admission
Correlation between PTIF and carbon dioxide (CO2)	Correlation between PTIF (l/kg/min) and carbon dioxide (CO2) (mmHg) measured by capillary blood gases or with transcutaneous electrodes	1 day
Duration of hospitalization	Duration of hospitalization	1 day at the end of the hospitalization

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Christophe MILESI, MD, PhD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2017
• Primary Completion (Actual): January 16, 2019
• Study Completion (Actual): January 16, 2019

Study Registration Dates

• First Submitted: July 19, 2017
• First Submitted That Met QC Criteria: September 26, 2017
• First Posted (Actual): October 2, 2017

Study Record Updates

• Last Update Posted (Actual): December 27, 2021
• Last Update Submitted That Met QC Criteria: December 23, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: spirometry; Inspiratory flow; High flow nasal cannula, spirometry; physiologic study; Bronchiolitis patients sverity score mWCAS/ 3-5.
• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Respiratory Aspiration; Bronchiolitis; Bronchiolitis, Viral
• Other Study ID Numbers: UF9868

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No