- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04677556
Work of Breathing in Bronchiolitis Under Non-invasive Ventilation (BRONCHIO-VNI)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Meryl VEDRENNE-CLOQUET, MD
- Phone Number: +33 1 71 39 68 43
- Email: meryl.vedrenne-ext@aphp.fr
Study Locations
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Paris, France, 75015
- Hopital Necker-Enfants Malades
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Severe acute bronchiolitis
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)
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Esophageal pressure-time product per minute (PTPes/min)
Time Frame: 20 minutes
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory rate (RR)
Time Frame: 20 minutes
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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.
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20 minutes
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Heart rate (HR)
Time Frame: 20 minutes
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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.
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20 minutes
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Inspiratory time (Ti)
Time Frame: 20 minutes
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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.
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20 minutes
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Total respiratory cycle time (Ttot)
Time Frame: 20 minutes
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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.
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20 minutes
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Tidal volume (Vt)
Time Frame: 20 minutes
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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.
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20 minutes
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Gas exchange
Time Frame: 3 hours
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SpO2 and PtcCO2, in mmHg will be continuously monitored thanks to a pulse oxymeter and transcutaneous capnography (SenTecTM) for 3 hours
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3 hours
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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
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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)
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At inclusion and at the end of the measurements, i.e. 3 hours from inclusion
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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
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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).
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At inclusion and at the end of the measurements, i.e. 3 hours from inclusion
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Work of breathing
Time Frame: 20 minutes
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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. |
20 minutes
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Need for intubation
Time Frame: Through study completion, an average of 2 years
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Through study completion, an average of 2 years
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Number of days under sedation by Midazolam IV or per os upon hospital discharge
Time Frame: Through study completion, an average of 2 years
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Through study completion, an average of 2 years
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Number of days under NIV
Time Frame: Through study completion, an average of 2 years
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Through study completion, an average of 2 years
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Number of days under invasive ventilation
Time Frame: Through study completion, an average of 2 years
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Through study completion, an average of 2 years
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Number of days in intensive care unit
Time Frame: Through study completion, an average of 2 years
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Through study completion, an average of 2 years
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Number of days in hospitalization
Time Frame: Through study completion, an average of 2 years
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Through study completion, an average of 2 years
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Patient-ventilator asynchronies (under NiPPV)
Time Frame: Through study completion, an average of 2 years
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Patient-ventilator asyncrhonies will be analyzed using the flow and pressure curves of the ventilator and the patient (Pes), then classified into 4 groups:
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Through study completion, an average of 2 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Meryl Vedrenne-Cloquet, MD, Assistance Publique - Hôpitaux de Paris
- Study Director: Brigitte Fauroux, MD, PhD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP200838
- 2020-A01419-30 (Other Identifier: ID-RCB Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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