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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 : Unknown
Verified February 2015 by Katherine Slain, Case Western Reserve University.
Recruitment status was:  Recruiting
First Posted : February 27, 2015
Last Update Posted : February 27, 2015
Sponsor:
Information provided by (Responsible Party):
Katherine Slain, Case Western Reserve University

Brief 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.

Condition or disease Intervention/treatment Phase
Bronchiolitis Heliox Pediatrics Device: Vapotherm-Heliox Not Applicable

Detailed 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Helium-oxygen Gas Mixtures Delivered by a High Flow Nasal Cannula in Bronchiolitis
Study Start Date : December 2014
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
Drug Information available for: Heliox

Arm Intervention/treatment
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.
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.

No Intervention: Standard Care
Care dictated by clinical team.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Need for reintubation [ Time Frame: During hospitalization, typically 4 days to 2 weeks ]
  2. PICU Length of Stay [ Time Frame: During hospitalization, typically 4 days to 2 weeks ]
  3. Hospital Length of Stay [ Time Frame: During hospitalization, typically 4 days to 2 weeks ]
  4. Length of treatment with supplemental oxygen [ Time Frame: During hospitalization, typically 4 days to 2 weeks ]


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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373683


Contacts
Contact: Katherine N Slain, DO 216-983-0088 katherine.slain@uhhospitals.org

Locations
United States, Ohio
Rainbow Babies Children's Hospital, University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Katherine N Slain, DO    216-983-0088    katherine.slain@uhhospitals.org   
Sponsors and Collaborators
Case Western Reserve University
Investigators
Principal Investigator: Alexandre Rotta, MD Rainbow Babies and Children's Hospital, University Hospitals Case Medical Center

Publications:

Responsible Party: Katherine Slain, DO, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT02373683     History of Changes
Other Study ID Numbers: 06-14-08
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: February 27, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections