BRONCHIO-VNI
Comparison Between Continuous Positive Airway Pressure (CPAP) and Non Invasive Positive Pressure Ventilation (NiPPV) in Bronchiolitis Under Non- Invasive Ventilation
Sponsor study identifier
Secondary identifiers
OTHER · ID-RCB Number
interventional
20
1 country
1
Study Start
January 5, 2021
Actual (reported)Primary Completion
January 8, 2022
Actual (reported)Study Completion
January 8, 2022
Actual (reported)Severe acute viral bronchiolitis is the leading cause of pediatric intensive care admission. The first-line recommended ventilation support is continuous positive airway pressure (CPAP), which reduces the work of breathing (WOB) and improves gas exchange. Although Non invasive Positive Pressure Ventilation (NiPPV) is increasingly used in case of CPAP failure to avoid intubation, no study has yet evaluated if this support could effectively reduce the effort of breathing. Our hypothesis is that NiPPV could reduce WOB more effectively than CPAP alone, and might lead to reduce intubation in the most severe bronchiolitis. The purpose of this study is to compare WOB between CPAP and NiPPV, thanks to esophageal pressure measurement, in infants hospitalized for severe acute bronchiolitis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 8, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 3, 2020
Actual (reported)December 21, 2020
Actual (reported)January 5, 2021
Actual (reported)January 8, 2022
Actual (reported)January 8, 2022
Actual (reported)Esophageal pressure-time product per minute (PTPes/min)
Esophageal pressure-time product per minute (PTPes/min) is calculated by the area under the curve of the Pes during inspiration, expressed in cmH2O.s / min. The PTPes/min will be measured under CPAP (" clinical" and "physiological" setting) and under NiPPV (" clinical" and "physiological" setting) during a period of quiet breathing of 5 minutes.
20 minutes
Respiratory rate (RR)
20 minutes
Heart rate (HR)
20 minutes
Inspiratory time (Ti)
20 minutes
Total respiratory cycle time (Ttot)
20 minutes
Tidal volume (Vt)
20 minutes
Infants under 6 months admitted in Pediatric Intensive Care Unit for a severe acute bronchiolitis needing NIV (modified Woof clinical asthma score (WCAS) \>4 and/or hypercapnic acidosis (pH\<7,3 and/or pCO2\>50mmHg)
Catheter placement : at least 2 hours after and within 24 hours following the initial ventilation support establishment (CPAP or NiPPV according to usual practice and clinical conditions). 2 periods of measurements : with the initial and with the 2nd ventilation support using a cross-over for each patient. For each period, the first serie of measurements will be carried out without modifying the settings of the support ( "clinical" setting), and the second one using esogastric pressures by adjusting the settings of the ventilation support in order to obtain an optimal normalization or reduction of the amplitude of the Pes and Pdi deltas ("physiological" setting). 5 minutes of spontaneous breathing with/without oxygen between period 1 and 2 (depending on the patient's conditions). All measurements will be performed for 5 minutes after a 15 minutes quiet breathing. After measurements, the optimal respiratory support will be continued.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hôpital Necker-Enfants Malades
Paris, 75015, France
Vedrenne-Cloquet M, Khirani S, Griffon L, Collignon C, Renolleau S, Fauroux B. Respiratory effort during noninvasive positive pressure ventilation and continuous positive airway pressure in severe acute viral bronchiolitis. Pediatr Pulmonol. 2023 Jul;58(7):2000-2008. doi: 10.1002/ppul.26424. Epub 2023 Apr 25.
Meryl VEDRENNE-CLOQUET, MD
Assistance Publique - Hôpitaux de Paris
Brigitte FAUROUX, MD, PhD
Assistance Publique - Hôpitaux de Paris
20 participants (actual enrollment reported by the registry).
First Submitted
December 3, 2020
First Posted
December 21, 2020
Study Start
January 5, 2021
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
January 8, 2022
Actual (reported)Study Completion
January 8, 2022
Actual (reported)Last Updated
March 9, 2026
Record last verified: 2025-03
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Source: ClinicalTrials.gov.
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