Helium-oxygen Gas Mixtures Delivered by a High Flow Nasal Cannula in

Status Terminated

Clinical Trial Summary

The aim of this prospective pilot study is to determine the effect of heliox delivered via a proprietary calibrated heated and humidified high flow nasal cannula (HFNC) system (Vapotherm Precision Flow Heliox) in children ages 0-24 months with severe bronchiolitis.

Clinical Trial Description

Respiratory syncytial virus associated bronchiolitis is a leading cause of global infant morbidity and mortality [1], yet care remains largely supportive. Several recent studies show that a helium-oxygen gas mixture (heliox) improves outcomes in children with moderate to severe bronchiolitis [2-5, 7]. Heliox is a safe, inert gas with no biological effects and very low density [6]. By improving laminar flow, heliox improves gas exchange in conditions where airway resistance is increased, such as asthma, croup and bronchiolitis [6]. Recent data shows that infants with moderate to severe bronchiolitis have a reduced length of hospital stay when heliox is delivered via facemask or CPAP, as compared to heliox via nasal cannula [2]. Limitations to this study include the small number of patients (84/319 [26%]) who tolerated the facemask therapy and the fact that nasal cannula heliox was delivered at low flows (3 LPM). Oxygen is increasingly being delivered with a heated, humidified, high flow nasal cannula (HFNC) system to infants with moderate to severe bronchiolitis in our PICU. To date, there are no definitive randomized controlled trials that show the HFNC system is an effective treatment in bronchiolitis. However, there are several retrospective, prospective and pilot interventional studies showing clinical improvement in this patient population treated with the HFNC system [8-11]. We hypothesize that delivering heliox via a heated, humidified, high flow nasal cannula will be well tolerated, safe and effective. Specific Aim #1: The aim of this prospective pilot study is to determine the effect of heliox delivered via a proprietary calibrated heated and humidified high flow nasal cannula (HFNC) system (Vapotherm Precision Flow Heliox) in children ages 0-24 months with severe bronchiolitis. Hypothesis #1: Clinical and physiologic markers of respiratory distress will be improved in patients receiving heliox via HFNC compared to standard therapy following separation from mechanical ventilation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02373683
Study type	Interventional
Source	Case Western Reserve University
Contact
Status	Terminated
Phase	N/A
Start date	December 2014
Completion date	November 2015

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Helium-oxygen Gas Mixtures Delivered by a High Flow Nasal Cannula in Bronchiolitis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms