Non Invasive Ventilation in Bronchiolitis

Study Overview
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Brief Summary
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It is decided to perform a prospective study in a non-selected population of infants with bronchiolitis during one year ( October.2018 to October.2019) to study the characteristics, clinical course and outcome of the use of Non invasive ventilation in the management and compare the results with those treated with invasive ventilation to assess safety and efficacy and inform guideline construction.

Detailed Description
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Acute viral bronchiolitis is one of the most common respiratory diseases in early childhood and is a major health problem worldwide. The seasonal burden of the disease, the number of hospitalizations each year and the risk of subsequent asthma bring about substantial costs in developed countries. Respiratory syncytial virus and Human Rhinovirus seem to be the most frequent etiologic agents, but other viruses such as human Metapneumovirus, Influenza virus, and Parainfluenza virus can also be involved. The spectrum of clinical outcomes is wide, but bronchiolitis is more severe when caused by Respiratory syncytial virus. In contrast, while Human Rhinovirus is involved in milder forms, it is more likely to be associated with recurrent wheezing in infancy. Acute respiratory failure from pneumonia, influenza, and respiratory syncytial virus is responsible for 4.25 million deaths world-wide and the leading cause of mortality in low and middle-income countries. In the United Kingdom up to 7% of bronchiolitis admissions require intensive care for ventilatory support. One third of unplanned infant admissions to pediatric intensive care units have respiratory failure, the majority due to bronchiolitis, require invasive mechanical ventilation for 4-7 days and a prolonged hospital stay. In countries where there is no retrieval infrastructure, the need to develop safe and effective alternatives to invasive ventilation and pediatric intensive care unit admission is acute. However, none of the interventions commonly used for infants admitted with bronchiolitis is backed by robust evidence of benefit for clinically significant outcomes, making this a pressing subject for further study. Typically, intensive respiratory support for bronchiolitis is via invasive mechanical ventilation through an artificial airway, an intervention with recognized complications in infants. There is evidence to support the use of non-invasive ventilation in pediatric acute respiratory failure of variable causes.Although evidence for use in bronchiolitis is increasing,clinical acceptance is not universal and published best practice guidelines are not easily available.

Official Title
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Non Invasive Ventilation Versus Invasive Ventilation in Management of Bronchiolitis

Conditions
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Non Invasive Ventilation

Intervention / Treatment
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* Device: non invasive ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all infants with acute severe bronchiolitis, infants aged below 1 year. Exclusion Criteria: patients who have contraindications for NIV (patients with maxillofacial trauma, gastrointestinal obstruction and severe secretion), Children who had suspected or confirmed underlying chronic diseases (i.e., cystic fibrosis, chronic pulmonary disease, congenital heart disease, bronchopulmonary disease, prematurity, Children who had already more than one wheezing episode.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non invasive<br>infants who fulfill criteria of severe bronchiolitis will be connected to non invasive ventilation | Device: non invasive ventilation<br>* patients who will fulfill the criteria of severe bronchiolitis will be connected to non invasive ventilation including continuous positive airway pressure via nasal prongs or nasal mask. Mode of ventilation, inspired oxygen levels, oxygen saturation, respiratory rate, and blood gas values from arterial samples prior to and after 2 and 4 hrs of ventilation or nearest time, will be documented.<br>|
| No Intervention: invasive<br>infants who were connected to invasive mechanical ventilation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease risk of respiratory failure | in the form of ( pulse oximetry less than 94⁒, pao2 less than 60mmHg, paco2 more than 84mmHg ) while on NIV that lead to connection to invasive mechanical ventilation. | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease length of hospital stay | by prevention of ventilation acquired pneumonia and barotrauma that occur from use of invasive ventilation. | 7 days |