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

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ClinicalTrials.gov Identifier: NCT02373683
Recruitment Status : Terminated
First Posted : February 27, 2015
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Katherine Slain, Case Western Reserve University

February 23, 2015
February 27, 2015
July 25, 2018
December 2014
November 2015   (Final data collection date for primary outcome measure)
Respiratory Assessment Score [ Time Frame: 48 hours ]
Change in the respiratory assessment score from baseline (within 15 minutes of extubation) to 48 hours after extubation.
Same as current
Complete list of historical versions of study NCT02373683 on ClinicalTrials.gov Archive Site
  • Need for reintubation [ Time Frame: During hospitalization, typically 4 days to 2 weeks ]
  • PICU Length of Stay [ Time Frame: During hospitalization, typically 4 days to 2 weeks ]
  • Hospital Length of Stay [ Time Frame: During hospitalization, typically 4 days to 2 weeks ]
  • Length of treatment with supplemental oxygen [ Time Frame: During hospitalization, typically 4 days to 2 weeks ]
Same as current
Not Provided
Not Provided
 
Helium-oxygen Gas Mixtures Delivered by a High Flow Nasal Cannula in Bronchiolitis
Helium-oxygen Gas Mixtures Delivered by a High Flow Nasal Cannula in Bronchiolitis
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Bronchiolitis
  • Heliox
  • Pediatrics
Device: Vapotherm-Heliox
Following separation from mechanical ventilation, patient is placed on heliox (70% oxygen-30% helium) delivered with Vapotherm, a proprietary heated, humidified, high-flow nasal cannula delivery system.
  • Experimental: Vapotherm-Heliox
    Following separation from mechanical ventilation, patient is placed on heliox (70% oxygen-30% helium) delivered with Vapotherm, a proprietary heated, humidified, high-flow nasal cannula delivery system.
    Intervention: Device: Vapotherm-Heliox
  • No Intervention: Standard Care
    Care dictated by clinical team.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
20
November 2015
November 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children 0-24 months
  • Admission to the Pediatric Intensive Care Unit
  • Diagnosis of bronchiolitis, with respiratory syncytial virus infection confirmed by laboratory testing
  • Mechanical ventilation

Exclusion Criteria:

  • Inclusion in another clinical trial
  • Significant cardiac disease
  • Anatomically abnormal airway
  • Neurologic disease
  • Immunodeficiency
  • History of chronic lung disease
  • Craniofacial anomaly
  • Chromosomal anomalies
  • Known or suspected dysphagia
Sexes Eligible for Study: All
up to 2 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02373683
06-14-08
Yes
Not Provided
Not Provided
Katherine Slain, Case Western Reserve University
Case Western Reserve University
Not Provided
Principal Investigator: Alexandre Rotta, MD Rainbow Babies and Children's Hospital, University Hospitals Case Medical Center
Case Western Reserve University
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP