Severe Viral BronchiolitisBRONCHIO-VNINCT04677556
Work of Breathing in Bronchiolitis Under Non-invasive Ventilation
A study testing Esogastric pressures measurement in people with Severe Viral Bronchiolitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Severe Viral Bronchiolitis
- What is being tested?
- Esogastric pressures measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jan 2021to 8 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical and radiological diagnosis of bronchiolitis
- Need for non-invasive ventilation support (NiPPV or CPAP) with a modified Wood clinical asthma score (m-WCAS)> 4 and / or hypercapnic acidosis (pH <7.3 and / or pCO2> 50mmHg)
- Written parental informed consent
Who cannot join
- Contraindication to nasogastric tube (recent surgery of the esophagus, esophageal malformation at risk of perforation, severe coagulopathy)
- Absolute or relative contraindication to NIV
- Respiratory collapse: coma (GCS <12) and / or more than 3 apneas per hour with bradycardia <90 / min and / or SpO2 <90%
- Pneumothorax
- Preexisting disorder that may influence WOB
- Neuromuscular disease
- Chronic respiratory failure already under NIV or tracheostomy at home
- No social security
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Continuous Positive Airway Pressure (CPAP) and Non Invasive Positive Pressure Ventilation (NiPPV) in Bronchiolitis Under Non- Invasive Ventilation
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.
Read the detailed description
Severe acute viral bronchiolitis is the leading cause of pediatric intensive care admission. The first-line recommended ventilation support is non invasive ventilation (NIV) with continuous positive airway pressure (CPAP), which has been proved to reduce the work of breathing (WOB) and improve gas exchange. Non invasive Positive Pressure Ventilation (NiPPV) is increasingly used in case of CPAP failure to avoid intubation. Nevertheless, no study has ever evaluated its effectiveness on the discharge of respiratory muscles in severe bronchiolitis.
Measurement of esophageal and gastric pressures with an esogastric catheter allows an estimation of WOB thanks to the calculation of the esophageal pressure-time product (PTPes), and a calculation of the transdiaphragmatic pressure (Pdi) as the difference between gastric and esophageal pressures. This minimally invasive technique can be used at the bedside to assess the efficacy of ventilation support and is now increasingly used in Intensive Care Units to assist ventilation-targeted strategies.
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 main purpose of this study is to compare PTPes/min between CPAP and NiPPV in infants hospitalized for severe acute bronchiolitis.
Secondary objectives are i) to compare other parameters of WOB, gas exchanges and breathing pattern in both ventilator supports ii) to compare the rate of patient-ventilator asynchronies in 2 different setting of NiPPV ("clinical" and "physiological") iii) to assess if NiPPV is associated with reduced intubation rate, time under sedation and ventilation, and length of hospitalization as compared to CPAP.
- Conditions
- Severe Viral Bronchiolitis
- Being tested
- Esogastric pressures measurement
- Keywords
- Severe acute bronchiolitis, Non-invasive positive pressure ventilation, Continuous positive airway pressure, Work of breathing, Pediatric intensive care
- Medical subject headings
- Bronchiolitis, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esogastric pressures measurementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Severe acute bronchiolitis | Other | 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) Receives: Other: Esogastric pressures measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes
Secondary outcomes (16)
Respiratory rate (RR)
Breathing pattern Paramaters will be measured under CPAP ("clinical" and "physiological" setting) and NiPPV (" clinical" and "physiological" setting) during a period of quiet breathing of 5 minutes.
Measured: 20 minutes
Heart rate (HR)
In pulses per minute Breathing pattern Paramaters will be measured under CPAP ("clinical" and "physiological" setting) and NiPPV (" clinical" and "physiological" setting) during a period of quiet breathing of 5 minutes.
Measured: 20 minutes
Inspiratory time (Ti)
In sec Breathing pattern Paramaters will be measured under CPAP ("clinical" and "physiological" setting) and NiPPV (" clinical" and "physiological" setting) during a period of quiet breathing of 5 minutes.
Measured: 20 minutes
Total respiratory cycle time (Ttot)
In sec Breathing pattern Paramaters will be measured under CPAP ("clinical" and "physiological" setting) and NiPPV (" clinical" and "physiological" setting) during a period of quiet breathing of 5 minutes.
Measured: 20 minutes
Tidal volume (Vt)
In mL Breathing pattern Paramaters will be measured under CPAP ("clinical" and "physiological" setting) and NiPPV (" clinical" and "physiological" setting) during a period of quiet breathing of 5 minutes.
Measured: 20 minutes
Gas exchange
SpO2 and PtcCO2, in mmHg will be continuously monitored thanks to a pulse oxymeter and transcutaneous capnography (SenTecTM) for 3 hours
Measured: 3 hours
Modified Wood's Clinical Asthma Score (m-WCAS)
Modified Wood's Clinical Asthma Score (m-WCAS) is a respiratory failure score that includes 3 levels of gravity corresponding to 5 respiratory distress clinical signs. Values ranged from 0 (best score) to 10 (worst score)
Measured: At inclusion and at the end of the measurements, i.e. 3 hours from inclusion
PEdiatric Logistic Organ Dysfunction-2 score (PELOD-2)
Pediatric logistic organ dysfunction score is a specific pediatric multiple organ dysfunction score that includes 10 variables corresponding to 5 organ dysfunctions. Values extend from 0 (best outcome) to 33 (worst outcome).
Measured: At inclusion and at the end of the measurements, i.e. 3 hours from inclusion
Work of breathing
Esophageal pressure delta (ΔPES, normal between 5 and 8 cmH2O) Transdiaphragmatic pressure delta (ΔPdi). The Pdi is obtained by subtracting the Pes from the Pgas Pressure-time product of the diaphragm per minute (PTPDdi/min).
Paramaters 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.
Measured: 20 minutes
Need for intubation
Measured: Through study completion, an average of 2 years
Number of days under sedation by Midazolam IV or per os upon hospital discharge
Measured: Through study completion, an average of 2 years
Number of days under NIV
Measured: Through study completion, an average of 2 years
Number of days under invasive ventilation
Measured: Through study completion, an average of 2 years
Number of days in intensive care unit
Measured: Through study completion, an average of 2 years
Number of days in hospitalization
Measured: Through study completion, an average of 2 years
Patient-ventilator asynchronies (under NiPPV)
Patient-ventilator asyncrhonies will be analyzed using the flow and pressure curves of the ventilator and the patient (Pes), then classified into 4 groups:
- auto-triggering (cycle delivered by the ventilator without patient's inspiratory effort),
- double triggering (2 successive cycles delivered by the ventilator for a single inspiratory effort of the patient),
- wasted effort (patient inspiratory effort not followed by a cycle delivered by the ventilator),
- daly asynchronies (advance or delay of the cycle delivered by the ventilator compared to the start of the patient's inspiration or expiration) The percentage of patient-ventilator asynchronies will be analyzed under NiPPV ("clinical" setting and "physiological" setting) during a period of quiet breathing of 5 minutes.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start5 Jan 2021
- Primary completion8 Jan 2022
- Study completion8 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Viral BronchiolitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Meryl VEDRENNE-CLOQUET, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisBrigitte FAUROUX, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677556
- Sponsor's protocol ID
- APHP200838
- Other IDs
- 2020-A01419-30
- Acronym
- BRONCHIO-VNI
- Status last verified
- Mar 2025
- First submitted
- 3 Dec 2020
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37097049
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Continuous Positive Airway Pressure (CPAP) and Non Invasive Positive Pressure Ventilation (NiPPV) in Bronchiolitis Under Non- Invasive Ventilation
- ClinicalTrials.gov ID
- NCT04677556
- Acronym / sponsor ID
- BRONCHIO-VNI / APHP200838
- Conditions
- Severe Viral Bronchiolitis
- Keywords
- Severe acute bronchiolitis, Non-invasive positive pressure ventilation, Continuous positive airway pressure, Work of breathing, Pediatric intensive care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 8 Jan 2022 (actual)
- Study completion
- 8 Jan 2022 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Severe acute viral bronchiolitis is the leading cause of pediatric intensive care admission. The first-line recommended ventilation support is non invasive ventilation (NIV) with continuous positive airway pressure (CPAP), which has been proved to reduce the work of breathing (WOB) and improve gas exchange. Non invasive Positive Pressure Ventilation (NiPPV) is increasingly used in case of CPAP failure to avoid intubation. Nevertheless, no study has ever evaluated its effectiveness on the discharge of respiratory muscles in severe bronchiolitis.
Measurement of esophageal and gastric pressures with an esogastric catheter allows an estimation of WOB thanks to the calculation of the esophageal pressure-time product (PTPes), and a calculation of the transdiaphragmatic pressure (Pdi) as the difference between gastric and esophageal pressures. This minimally invasive technique can be used at the bedside to assess the efficacy of ventilation support and is now increasingly used in Intensive Care Units to assist ventilation-targeted strategies.
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 main purpose of this study is to compare PTPes/min between CPAP and NiPPV in infants hospitalized for severe acute bronchiolitis.
Secondary objectives are i) to compare other parameters of WOB, gas exchanges and breathing pattern in both ventilator supports ii) to compare the rate of patient-ventilator asynchronies in 2 different setting of NiPPV ("clinical" and "physiological") iii) to assess if NiPPV is associated with reduced intubation rate, time under sedation and ventilation, and length of hospitalization as compared to CPAP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe acute bronchiolitis | Other | Other: Esogastric pressures measurementInfants 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) |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Clinical and radiological diagnosis of bronchiolitis
- Need for non-invasive ventilation support (NiPPV or CPAP) with a modified Wood clinical asthma score (m-WCAS)> 4 and / or hypercapnic acidosis (pH <7.3 and / or pCO2> 50mmHg)
- Written parental informed consent
Key exclusion criteria (8 listed)
- Contraindication to nasogastric tube (recent surgery of the esophagus, esophageal malformation at risk of perforation, severe coagulopathy)
- Absolute or relative contraindication to NIV
- Preexisting disorder that may influence WOB
- No social security
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esogastric pressures measurementCatheter 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. | Other | Severe acute bronchiolitis |
Primary outcome
Esophageal pressure-time product per minute (PTPes/min)
Time frame: 20 minutes
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.
16 secondary outcomes
Respiratory rate (RR)
Time frame: 20 minutes
Heart rate (HR)
Time frame: 20 minutes
Inspiratory time (Ti)
Time frame: 20 minutes
Total respiratory cycle time (Ttot)
Time frame: 20 minutes
Tidal volume (Vt)
Time frame: 20 minutes
Gas exchange
Time frame: 3 hours
Modified Wood's Clinical Asthma Score (m-WCAS)
Time frame: At inclusion and at the end of the measurements, i.e. 3 hours from inclusion
PEdiatric Logistic Organ Dysfunction-2 score (PELOD-2)
Time frame: At inclusion and at the end of the measurements, i.e. 3 hours from inclusion
Work of breathing
Time frame: 20 minutes
Need for intubation
Time frame: Through study completion, an average of 2 years
Number of days under sedation by Midazolam IV or per os upon hospital discharge
Time frame: Through study completion, an average of 2 years
Number of days under NIV
Time frame: Through study completion, an average of 2 years
Number of days under invasive ventilation
Time frame: Through study completion, an average of 2 years
Number of days in intensive care unit
Time frame: Through study completion, an average of 2 years
Number of days in hospitalization
Time frame: Through study completion, an average of 2 years
Patient-ventilator asynchronies (under NiPPV)
Time frame: Through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Results publication: PubMed 37097049Vedrenne-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meryl VEDRENNE-CLOQUET, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Brigitte FAUROUX, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esogastric pressures measurement in people with Severe Viral Bronchiolitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophageal pressure-time product per minute (PTPes/min) (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04677556, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.