Peak Tidal Inspiratory Flow in Infants With Moderate to Severe Acute Viral Bronchiolitis (DEBIB)
Primary Purpose
Bronchiolitis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Measurement of the peak tidal inspiratory flow (PTIF)
Sponsored by
About this trial
This is an interventional screening trial for Bronchiolitis focused on measuring Inspiratory flow, High flow nasal cannula, spirometry, spirometry, physiologic study, Bronchiolitis patients sverity score mWCAS/ 3-5.
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.
Sites / Locations
- Uhmontpellier
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Bronchiolitis patients sverity
Arm Description
In patients with bronchiolitis mWCAS / 3-5 : Measurement of the peak tidal inspiratory flow (PTIF)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Correlation between PTIF and Silverman score
Correlation between PTIF (l/kg/min) and Silverman score (0 to 10)
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
Correlation between PTIF and respiratory rate (FR)
Correlation between PTIF (l/kg/min) and respiratory rate (FR) (breath/min)
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
Duration of hospitalization
Duration of hospitalization
Full Information
NCT ID
NCT03298217
First Posted
July 19, 2017
Last Updated
December 23, 2021
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT03298217
Brief Title
Peak Tidal Inspiratory Flow in Infants With Moderate to Severe Acute Viral Bronchiolitis
Acronym
DEBIB
Official Title
Peak Tidal Inspiratory Flow in Infants With Moderate to Severe Acute Viral Bronchiolitis: a Physiologic Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 21, 2017 (Actual)
Primary Completion Date
January 16, 2019 (Actual)
Study Completion Date
January 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Inspiratory flow, High flow nasal cannula, spirometry, spirometry, physiologic study, Bronchiolitis patients sverity score mWCAS/ 3-5.
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bronchiolitis patients sverity
Arm Type
Other
Arm Description
In patients with bronchiolitis mWCAS / 3-5 : Measurement of the peak tidal inspiratory flow (PTIF)
Intervention Type
Device
Intervention Name(s)
Measurement of the peak tidal inspiratory flow (PTIF)
Intervention Description
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 Measure Information:
Title
Measurement of peak or peak inspiration flow (PTIF=peak tidal inspiratory flow)
Description
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.
Time Frame
1 day but within 24 hours of patient admission
Secondary Outcome Measure Information:
Title
Proportion of patients with a spontaneous PTIF higher than 2 L/kg/min
Description
Proportion of patients with a spontaneous PTIF higher than 2 L/kg/min
Time Frame
1 day but within 24 hours of patient admission
Title
Correlation between PTIF and Silverman score
Description
Correlation between PTIF (l/kg/min) and Silverman score (0 to 10)
Time Frame
1 day but within 24 hours of patient admission
Title
Correlation between PTIF and modified Wood's clinical asthma score
Description
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
Time Frame
1 day but within 24 hours of patient admission
Title
Correlation between PTIF and respiratory rate (FR)
Description
Correlation between PTIF (l/kg/min) and respiratory rate (FR) (breath/min)
Time Frame
1 day but within 24 hours of patient admission
Title
Correlation between PTIF and carbon dioxide (CO2)
Description
Correlation between PTIF (l/kg/min) and carbon dioxide (CO2) (mmHg) measured by capillary blood gases or with transcutaneous electrodes
Time Frame
1 day
Title
Duration of hospitalization
Description
Duration of hospitalization
Time Frame
1 day at the end of the hospitalization
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe MILESI, MD, PhD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uhmontpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
NC
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Peak Tidal Inspiratory Flow in Infants With Moderate to Severe Acute Viral Bronchiolitis
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