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

NCT ID: NCT02602678

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Severe Bronchiolitis

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PRONE-Supine

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).

Group Type EXPERIMENTAL

Prone then supine position

Intervention Type PROCEDURE

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)

SUPINE - Prone

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).

Group Type EXPERIMENTAL

Supine then Prone position

Intervention Type PROCEDURE

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)

Interventions

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Supine 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)

Intervention Type PROCEDURE

Prone 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)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospices Civils de Lyon

Bron, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 30448014 (View on PubMed)

Other Identifiers

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69HCL15_0430

Identifier Type: -

Identifier Source: org_study_id