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

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ClinicalTrials.gov Identifier: NCT03298217
Recruitment Status : Recruiting
First Posted : October 2, 2017
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.


Condition or disease Intervention/treatment Phase
Bronchiolitis Device: Measurement of the peak tidal inspiratory flow (PTIF) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Peak Tidal Inspiratory Flow in Infants With Moderate to Severe Acute Viral Bronchiolitis: a Physiologic Study
Actual Study Start Date : November 21, 2017
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 1, 2018

Arm Intervention/treatment
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).





Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03298217


Contacts
Contact: Christophe MILESI, MD, PhD 467336609 ext 33 c-milesi@chu-montpellier.fr

Locations
France
Uhmontpellier Recruiting
Montpellier, France, 34295
Contact: Christophe MILESI, MD, phD    467336609 ext 33    c-milesi@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Christophe MILESI, MD, PhD University Hospital, Montpellier

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03298217     History of Changes
Other Study ID Numbers: UF9868
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Montpellier:
Inspiratory flow
High flow nasal cannula, spirometry
spirometry
physiologic study
Bronchiolitis patients sverity score mWCAS/ 3-5.

Additional relevant MeSH terms:
Bronchiolitis
Respiratory Aspiration
Bronchiolitis, Viral
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Respiration Disorders
Pathologic Processes
Virus Diseases