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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2015 by Katherine Slain, Case Western Reserve University.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Katherine Slain, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT02373683
First received: February 23, 2015
Last updated: NA
Last verified: February 2015
History: No changes posted
  Purpose
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 Intervention
Bronchiolitis Heliox Pediatrics Device: Vapotherm-Heliox

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Helium-oxygen Gas Mixtures Delivered by a High Flow Nasal Cannula in Bronchiolitis

Resource links provided by NLM:


Further study details as provided by Katherine Slain, Case Western Reserve University:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: December 2014
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Katherine Slain, DO, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT02373683     History of Changes
Other Study ID Numbers: 06-14-08
Study First Received: February 23, 2015
Last Updated: February 23, 2015

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

ClinicalTrials.gov processed this record on June 23, 2017