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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02602678
Acronym
BRONCHIO-DV
Enrollment
16
Registered
2015-11-11
Start date
2015-11-30
Completion date
2016-01-31
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Bronchiolitis

Keywords

Children., prone position, acute viral bronchiolitis, syncytial virus, work of breathing, intrinsic PEEP

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.

Interventions

PROCEDURESupine then Prone position

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)

PROCEDUREProne then supine position

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)

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Work of breathing60 minThe 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

MeasureTime frameDescription
Inspiratory:Expiratory Time Ratio60 minMean on 100 breaths of the Inspiratory:Expiratory Time Ratio
Heart rate60 minEvolution of the clinical and oxygenation parameter within the first hour in each position.
Respiratory rate60 minEvolution of the clinical and oxygenation parameters within the first hour in each position.
Intrinsic PEEP60 minMean on 10 breaths of the intrinsic positive end expiratory pressure in spontaneous ventilation
Transcutaneous CO260 minEvolution of the clinical and oxygenation parameters within the first hour in each position.
EDIN score (neonatal pain and discomfort scale)60 min
SPO260 minEvolution of the clinical and oxygenation parameters within the first hour in each position.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026