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Chest and Abdominal Wall Strapping in Infant With Bronchiolitis (WRAPITIS)

Primary Purpose

Bronchiolitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Chest wall strapping
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring Bronchiolitis, Work of breathing, Non-invasive ventilation, Infant

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Infant < 6 months Admitted to the PICU for less than 48 hours With a diagnosis of bronchiolitis With a respiratory distress sign (mWCAS ≥ 3) and non-invasive ventilatory support With a naso or oro gastric tube for feeding With written informed consent from parents or legal guardians Exclusion Criteria: Infants with severe bronchopulmonary disease, severe laryngomalacia, neuromuscular disease, bone disease, cyanotic heart disease Contraindication to the use of a gastric tube recent abdominal or thoracic surgery investigator able to perform physiological recording not available Patient who is not affiliated (or does not benefit from) to a national social security system

Sites / Locations

  • Réanimation pédiatrique

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Infant < 6 months with severe bronchiolitis

Arm Description

Infant will be recorded successively in 6 conditions (10 min each) : Without chest wall strapping at PEEP 0 and PEEP 7 With chest wall strapping at PEEP 0 and PEEP 7 again without chest wall strapping at PEEP 0 and PEEP 7.

Outcomes

Primary Outcome Measures

Esophagal product time pressure
Average over 100 consecutive cycles of esophageal product time pressure value

Secondary Outcome Measures

Diaphragmatic product time pressure
Average over 100 consecutive cycles of diaphragmatic product time pressure value
Esophagal and diaphragmatic swing
Mean on 100 breaths of the amplitude (maximum value -minimum value) of the esophageal pressure (cmH2O) and gastric pressure (cmH2O)
Distribution of ventilation : center of ventilation
Mean over 1 minute of the center of the ventilation (%). Center of ventilation represents the average of the dorsal-ventral distribution of tidal variation using Electrical Impedance Tomography (values >50% indicating that the center of ventilation is located in the ventral part of the chest)
End expiratory lung volume
Average over 1 minute of the end expiratory lung impedance
Time ratio
average over 100 consecutive cycles of inspiratory to aspiratory time ratio
modified wood asthma score (mWCAS)
Value of the modified wood asthma score at the end of the recording period in each condition. Minimal value 0 and maximal value 10. A score ≥ 3 mean a moderate-to-severe respiratory distress.
TcPCO2
Average of the transcutaneous CO2 (carbon dioxide) partial over 1 minute
EDIN scale (Newborn Pain and Discomfort Scale)
Value of the EDIN score at the end of the recording period in each condition. Minimal value 0 and maximal value 15. EDIN scores > 6 are considered expression of pain

Full Information

First Posted
September 25, 2023
Last Updated
October 12, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT06083077
Brief Title
Chest and Abdominal Wall Strapping in Infant With Bronchiolitis
Acronym
WRAPITIS
Official Title
Effect of Chest and Abdominal Wall Strapping on Ventilation and Work of Breathing in Infants With Severe Bronchiolitis: a Physiological Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

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
Bronchiolitis is the most common cause of admission to the Paediatric Intensive Care Unit (PICU) for respiratory distress. The care of an infant with severe bronchiolitis is mainly based on symptomatic treatment (nutritional and respiratory support). The lower part of an infant's chest is larger than that of an older child, which can flatten the diaphragm, especially in obstructive disease with air trapping. Strapping the lower part (at the junction of the chest and abdomen) may provide a better condition for diaphragmatic contraction. Based on respiratory mechanics in infants and physiological studies in adults, investigators hypothesise that chest wall strapping may improve the ventilation and the diaphragmatic contraction. Infant < 6 month with severe bronchiolitis admitted to the PICU will be recorded in 4 conditions with or without chest wall strapping and with a Continuous Positive Airway Pressure (CPAP) at 7 cmH2O or without CPAP. Physiological parameters (including work of breathing, respiratory parameters, distribution of ventilation) will be recorded and analysed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Bronchiolitis, Work of breathing, Non-invasive ventilation, Infant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Infant will be recorded successively in 6 conditions (10 min each) : Without chest wall strapping at PEEP (Positive End Expiratory Pressure) 0 and PEEP 7 With chest wall strapping at PEEP 0 and PEEP 7 again without chest wall strapping at PEEP 0 and PEEP 7.
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Infant < 6 months with severe bronchiolitis
Arm Type
Experimental
Arm Description
Infant will be recorded successively in 6 conditions (10 min each) : Without chest wall strapping at PEEP 0 and PEEP 7 With chest wall strapping at PEEP 0 and PEEP 7 again without chest wall strapping at PEEP 0 and PEEP 7.
Intervention Type
Other
Intervention Name(s)
Chest wall strapping
Intervention Description
An elastic band (6 cm wide) is placed around the lower part of the chest wall (at the junction of the chest and abdomen) to tighten the chest wall for 10 min at PEEP 7 cmH2O and 10 min without PEEP
Primary Outcome Measure Information:
Title
Esophagal product time pressure
Description
Average over 100 consecutive cycles of esophageal product time pressure value
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Diaphragmatic product time pressure
Description
Average over 100 consecutive cycles of diaphragmatic product time pressure value
Time Frame
1 hour
Title
Esophagal and diaphragmatic swing
Description
Mean on 100 breaths of the amplitude (maximum value -minimum value) of the esophageal pressure (cmH2O) and gastric pressure (cmH2O)
Time Frame
1 hour
Title
Distribution of ventilation : center of ventilation
Description
Mean over 1 minute of the center of the ventilation (%). Center of ventilation represents the average of the dorsal-ventral distribution of tidal variation using Electrical Impedance Tomography (values >50% indicating that the center of ventilation is located in the ventral part of the chest)
Time Frame
1 hour
Title
End expiratory lung volume
Description
Average over 1 minute of the end expiratory lung impedance
Time Frame
1 hour
Title
Time ratio
Description
average over 100 consecutive cycles of inspiratory to aspiratory time ratio
Time Frame
1 hour
Title
modified wood asthma score (mWCAS)
Description
Value of the modified wood asthma score at the end of the recording period in each condition. Minimal value 0 and maximal value 10. A score ≥ 3 mean a moderate-to-severe respiratory distress.
Time Frame
1 hour
Title
TcPCO2
Description
Average of the transcutaneous CO2 (carbon dioxide) partial over 1 minute
Time Frame
1 hour
Title
EDIN scale (Newborn Pain and Discomfort Scale)
Description
Value of the EDIN score at the end of the recording period in each condition. Minimal value 0 and maximal value 15. EDIN scores > 6 are considered expression of pain
Time Frame
1 hour

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infant < 6 months Admitted to the PICU for less than 48 hours With a diagnosis of bronchiolitis With a respiratory distress sign (mWCAS ≥ 3) and non-invasive ventilatory support With a naso or oro gastric tube for feeding With written informed consent from parents or legal guardians Exclusion Criteria: Infants with severe bronchopulmonary disease, severe laryngomalacia, neuromuscular disease, bone disease, cyanotic heart disease Contraindication to the use of a gastric tube recent abdominal or thoracic surgery investigator able to perform physiological recording not available Patient who is not affiliated (or does not benefit from) to a national social security system
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florent BAUDIN, Dr
Phone
04 72 12 97 35
Ext
+33
Email
florent.baudin@chu-lyon.fr
Facility Information:
Facility Name
Réanimation pédiatrique
City
Bron
ZIP/Postal Code
69500
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florent BAUDIN, Dr
Phone
04 72 12 97 35
Ext
+33
Email
florent.baudin@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Florent BAUDIN, Dr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Chest and Abdominal Wall Strapping in Infant With Bronchiolitis

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