An interventional study of Esogastric pressures measurement in Severe Viral Bronchiolitis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged Up to 6 Months. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
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.
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.
30 studies on the registry are indexed under Bronchiolitis, Viral; 2 are open to participants now.
This study's enrollment of 20 is below the median of 85 across 25 interventional studies indexed under Bronchiolitis, Viral.
Browse Bronchiolitis, Viral studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Exclusion Criteria:
Absolute or relative contraindication to NIV
Preexisting disorder that may influence WOB
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Other: Esogastric pressures measurement
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.
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.
Time frame: 20 minutes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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)
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)
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).
Time frame: 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.
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)
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.
Time frame: Through study completion, an average of 2 years
Plan to share: No
Ran from Jan 2021 to primary completion in Jan 2022, 12 months.
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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