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Clinical Trial Summary

The investigators compared oxygen therapy using the HFNC and diffuser mask (an effective low-flow oxygen delivery system) to treat patients with moderate-to-severe acute bronchiolitis admitted to an intensive care unit (ICU).


Clinical Trial Description

Acute bronchiolitis results from inflammation of the bronchioles and is usually caused by a viral infection. It is most common in children younger than 2 years old and is one of the most frequent reasons why a child is admitted to hospital. There is no established, specific therapy for acute bronchiolitis and it is commonly treated using supplemental oxygen and by ensuring that the patient remains hydrated.

Oxygen therapy can be applied using a low- or high-flow oxygen delivery system. For example, a diffuser mask (OxyMask) is a low-flow delivery system, which is capable of delivering up to 90% of the fraction of inspired oxygen (FiO2) with low carbon dioxide (CO2) retention. In this system, the FiO2 can be adjusted by modifying the flow velocity to deliver the quantity of oxygen that the patient requires. Oxygen is supplied to the patient in a jet that flows from a device mounted on the oxygen mask. This ensures that a high concentration of oxygen is provided at a low flow rate. Additionally, CO2 retention is minimal because the mask has a fenestrated structure. Therefore, a diffuser mask is a more effective oxygen delivery method than many other low-flow delivery systems including the nasal cannula and simple oxygen mask.

Oxygen therapy using a high-flow nasal cannula (HFNC) is a high-flow oxygen delivery system that enhances the efficiency of respiration by using high flow rates to clear dead space and provide fresh oxygen. This system supplies oxygen at a high flow rate through a loose nasal cannula. HFNC therapy provides heated and humidified oxygen to fill the dead space in the nasopharynx and produces minimal positive airway pressure. It enhances the passage of air through the airway by reducing inspiratory pressure. Previous studies have demonstrated that using a HFNC can decrease respiratory effort and improve gas exchange. In recent years, many studies have suggested that high-flow nasal oxygen therapy is more effective than low-flow systems. This is substantiated by significant decreases in the use of mechanical ventilation since HFNC therapy was introduced.

Previous reports on the effectiveness of HFNC therapy in treating acute bronchiolitis have come primarily from observational work and there are few relevant, randomized controlled studies. Additionally, previous studies have compared HFNC therapy with less effective, low-flow systems (e.g., the simple mask or nasal cannula). To the best of our knowledge, no randomized controlled trial has compared the effectiveness of the HFNC and diffuser mask in treating bronchiolitis.

In this study, the investigators compared oxygen therapy using the HFNC and diffuser mask (an effective low-flow oxygen delivery system) to treat patients with moderate-to-severe acute bronchiolitis admitted to an intensive care unit (ICU). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03342781
Study type Interventional
Source Kayseri Training and Research Hospital
Contact
Status Completed
Phase N/A
Start date March 1, 2016
Completion date March 1, 2017

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