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

February 7, 2022 updated by: Katherine Slain, Case Western Reserve University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Rainbow Babies Children's Hospital, University Hospitals Case Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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. The score ranges from 0 to 12, with higher scores indicating worsening respiratory distress.
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Need for Reintubation
Time Frame: During hospitalization, typically 4 days to 2 weeks
During hospitalization, typically 4 days to 2 weeks
PICU Length of Stay
Time Frame: During hospitalization, typically 4 days to 2 weeks
During hospitalization, typically 4 days to 2 weeks
Hospital Length of Stay
Time Frame: During hospitalization, typically 4 days to 2 weeks
During hospitalization, typically 4 days to 2 weeks
Length of Treatment With Supplemental Oxygen
Time Frame: During hospitalization, typically 4 days to 2 weeks
During hospitalization, typically 4 days to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Western Reserve University

Investigators

  • Principal Investigator: Alexandre Rotta, MD, Rainbow Babies and Children's Hospital, University Hospitals Case Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

February 23, 2015

First Submitted That Met QC Criteria

February 23, 2015

First Posted (Estimate)

February 27, 2015

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-14-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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