search
Back to results

Prone Position Effects on Work of Breathing and Intrinsic PEEP in Children With Severe Acute Viral Bronchiolitis (BRONCHIO-DV)

Primary Purpose

Severe Bronchiolitis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Supine then Prone position
Prone then supine position
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Bronchiolitis focused on measuring Children., prone position, acute viral bronchiolitis, syncytial virus, work of breathing, intrinsic PEEP

Eligibility Criteria

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

Inclusion Criteria:

  • Infant < 6 months
  • Admitted in the pediatric intensive care unit of the Femme-Mère-Enfant hospital, Hospices Civils de Lyon, France
  • With severe acute viral bronchiolitis requiring ventilatory support (mWCAS > 4 and/or and or FiO2> 40% and/or hypercapnic acidosis (pH<7.30 and/or pCO2>8 kPa))
  • Signed informed consent by the two parents or the owner of parental authority

Exclusion Criteria:

  • Chronic respiratory, neuromuscular, ENT or cardiac disease
  • Contraindication for placement of esophageal probe (esophageal surgery, varices, …)
  • Children requiring invasive ventilation (more than 3 significant apneas in 1 hour, decreased consciousness, …)
  • Children not affiliated to a social security scheme

Sites / Locations

  • Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PRONE-Supine

SUPINE - Prone

Arm Description

We test the hypothesis that in infants with severe bronchiolitis, prone position reduces the work of breathing (WOB) and the intrinsic Positive End Expiratory Pressure (PEEP).

We test the hypothesis that in infants with severe bronchiolitis, prone position reduces the work of breathing (WOB) and the intrinsic Positive End Expiratory Pressure (PEEP).

Outcomes

Primary Outcome Measures

Work of breathing
The primary outcome is the work of breathing (WOB) estimated by the mean on 100 breaths of the esophageal and trans-diaphragmatic Pressure-Time Product (PTP) at the end of the first hour.

Secondary Outcome Measures

Intrinsic PEEP
Mean on 10 breaths of the intrinsic positive end expiratory pressure in spontaneous ventilation
Inspiratory:Expiratory Time Ratio
Mean on 100 breaths of the Inspiratory:Expiratory Time Ratio
Heart rate
Evolution of the clinical and oxygenation parameter within the first hour in each position.
Respiratory rate
Evolution of the clinical and oxygenation parameters within the first hour in each position.
SPO2
Evolution of the clinical and oxygenation parameters within the first hour in each position.
Transcutaneous CO2
Evolution of the clinical and oxygenation parameters within the first hour in each position.
EDIN score (neonatal pain and discomfort scale)

Full Information

First Posted
November 9, 2015
Last Updated
January 27, 2016
Sponsor
Hospices Civils de Lyon
search

1. Study Identification

Unique Protocol Identification Number
NCT02602678
Brief Title
Prone Position Effects on Work of Breathing and Intrinsic PEEP in Children With Severe Acute Viral Bronchiolitis
Acronym
BRONCHIO-DV
Official Title
Prone Position Effects on Work of Breathing and Intrinsic PEEP in Children With Severe Acute Viral Bronchiolitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Acute viral bronchiolitis is the first cause of respiratory distress in infant. Airway inflammation increases the respiratory system resistances and dynamic hyperinflation. This leads to an increase in the work of breathing. In Chronic obstructive pulmonary disease patients as in neonates, prone position (PP) improves lung function and decreases the end expiratory lung volume. The investigators hypothesized that in infants with severe bronchiolitis, prone position reduces the intrinsic Positive End Expiratory Pressure (PEEPi) and the work of breathing (WOB). The investigator designed a prospective randomized crossover study with 16 infants younger than six months who need ventilatory support by nasal continuous positive airway pressure (nCPAP) for severe acute viral bronchiolitis. Work of breathing (product time pressure) and PEEPi will be estimated using an esophageal pressure probe in prone and supine position.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Bronchiolitis
Keywords
Children., prone position, acute viral bronchiolitis, syncytial virus, work of breathing, intrinsic PEEP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRONE-Supine
Arm Type
Experimental
Arm Description
We test the hypothesis that in infants with severe bronchiolitis, prone position reduces the work of breathing (WOB) and the intrinsic Positive End Expiratory Pressure (PEEP).
Arm Title
SUPINE - Prone
Arm Type
Experimental
Arm Description
We test the hypothesis that in infants with severe bronchiolitis, prone position reduces the work of breathing (WOB) and the intrinsic Positive End Expiratory Pressure (PEEP).
Intervention Type
Procedure
Intervention Name(s)
Supine then Prone position
Intervention Description
One hour in supine position with CPAP (+7 cmH2O) then 15 min in supine position in spontaneous ventilation (wash-out) and one hour in prone position with CPAP (+7 cmH2O)
Intervention Type
Procedure
Intervention Name(s)
Prone then supine position
Intervention Description
One hour in prone position with CPAP (+7 cmH2O) then 15 min in supine position in spontaneous ventilation (wash out ) and one hour in supine position with CPAP (+7 cmH2O)
Primary Outcome Measure Information:
Title
Work of breathing
Description
The primary outcome is the work of breathing (WOB) estimated by the mean on 100 breaths of the esophageal and trans-diaphragmatic Pressure-Time Product (PTP) at the end of the first hour.
Time Frame
60 min
Secondary Outcome Measure Information:
Title
Intrinsic PEEP
Description
Mean on 10 breaths of the intrinsic positive end expiratory pressure in spontaneous ventilation
Time Frame
60 min
Title
Inspiratory:Expiratory Time Ratio
Description
Mean on 100 breaths of the Inspiratory:Expiratory Time Ratio
Time Frame
60 min
Title
Heart rate
Description
Evolution of the clinical and oxygenation parameter within the first hour in each position.
Time Frame
60 min
Title
Respiratory rate
Description
Evolution of the clinical and oxygenation parameters within the first hour in each position.
Time Frame
60 min
Title
SPO2
Description
Evolution of the clinical and oxygenation parameters within the first hour in each position.
Time Frame
60 min
Title
Transcutaneous CO2
Description
Evolution of the clinical and oxygenation parameters within the first hour in each position.
Time Frame
60 min
Title
EDIN score (neonatal pain and discomfort scale)
Time Frame
60 min

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infant < 6 months Admitted in the pediatric intensive care unit of the Femme-Mère-Enfant hospital, Hospices Civils de Lyon, France With severe acute viral bronchiolitis requiring ventilatory support (mWCAS > 4 and/or and or FiO2> 40% and/or hypercapnic acidosis (pH<7.30 and/or pCO2>8 kPa)) Signed informed consent by the two parents or the owner of parental authority Exclusion Criteria: Chronic respiratory, neuromuscular, ENT or cardiac disease Contraindication for placement of esophageal probe (esophageal surgery, varices, …) Children requiring invasive ventilation (more than 3 significant apneas in 1 hour, decreased consciousness, …) Children not affiliated to a social security scheme
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
30448014
Citation
Baudin F, Emeriaud G, Essouri S, Beck J, Portefaix A, Javouhey E, Guerin C. Physiological Effect of Prone Position in Children with Severe Bronchiolitis: A Randomized Cross-Over Study (BRONCHIO-DV). J Pediatr. 2019 Feb;205:112-119.e4. doi: 10.1016/j.jpeds.2018.09.066. Epub 2018 Nov 14.
Results Reference
derived

Learn more about this trial

Prone Position Effects on Work of Breathing and Intrinsic PEEP in Children With Severe Acute Viral Bronchiolitis

We'll reach out to this number within 24 hrs