Work of Breathing in Bronchiolitis Under Non-invasive Ventilation (NCT04677556) | Clinical Trial Compass
CompletedNot Applicable
Work of Breathing in Bronchiolitis Under Non-invasive Ventilation
France20 participantsStarted 2021-01-05
Plain-language 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. 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.
Who can participate
Age range
6 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Esophageal pressure-time product per minute (PTPes/min)