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

Sponsor
Case Western Reserve University (Other)
Overall Status
Terminated
CT.gov ID
NCT02373683
Collaborator
(none)
10
1
2
11
0.9

Study Details

Study Description

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
  • Device: Vapotherm-Heliox
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
10 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
Actual Study Start Date :
Dec 1, 2014
Actual Primary Completion Date :
Nov 1, 2015
Actual Study Completion Date :
Nov 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Respiratory Assessment Score [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.

Secondary Outcome Measures

  1. Need for Reintubation [During hospitalization, typically 4 days to 2 weeks]

  2. PICU Length of Stay [During hospitalization, typically 4 days to 2 weeks]

  3. Hospital Length of Stay [During hospitalization, typically 4 days to 2 weeks]

  4. Length of Treatment With Supplemental Oxygen [During hospitalization, typically 4 days to 2 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 2 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Rainbow Babies Children's Hospital, University Hospitals Case Medical Center Cleveland Ohio United States 44106

Sponsors and Collaborators

  • Case Western Reserve University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Katherine Slain, DO, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT02373683
Other Study ID Numbers:
  • 06-14-08
First Posted:
Feb 27, 2015
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Vapotherm-Heliox Standard Care
Arm/Group Description 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. 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. Care dictated by clinical team.
Period Title: Overall Study
STARTED 6 4
COMPLETED 6 4
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title Vapotherm-Heliox Standard Care Total
Arm/Group Description 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. 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. Care dictated by clinical team. Total of all reporting groups
Overall Participants 6 4 10
Age (months) [Median (Inter-Quartile Range) ]
Sex/Gender, Customized (Count of Participants)
Count of Participants [Participants]
0
0%
0
0%
0
0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]
0
0%
Primary diagnosis (Count of Participants)
Count of Participants [Participants]
0
0%
0
0%
0
0%

Outcome Measures

1. Primary Outcome
Title Respiratory Assessment Score
Description 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.
Time Frame 48 hours

Outcome Measure Data

Analysis Population Description
Study was terminated early. Data were not collected and results were not analyzed.
Arm/Group Title Vapotherm-Heliox Standard Care
Arm/Group Description 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. 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. Care dictated by clinical team.
Measure Participants 0 0
2. Secondary Outcome
Title Need for Reintubation
Description
Time Frame During hospitalization, typically 4 days to 2 weeks

Outcome Measure Data

Analysis Population Description
Study was terminated early. Data were not collected and results were not analyzed.
Arm/Group Title Vapotherm-Heliox Standard Care
Arm/Group Description 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. 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. Care dictated by clinical team.
Measure Participants 0 0
3. Secondary Outcome
Title PICU Length of Stay
Description
Time Frame During hospitalization, typically 4 days to 2 weeks

Outcome Measure Data

Analysis Population Description
Study was terminated early. Data were not collected and results were not analyzed.
Arm/Group Title Vapotherm-Heliox Standard Care
Arm/Group Description 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. 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. Care dictated by clinical team.
Measure Participants 0 0
4. Secondary Outcome
Title Hospital Length of Stay
Description
Time Frame During hospitalization, typically 4 days to 2 weeks

Outcome Measure Data

Analysis Population Description
Study was terminated early. Data were not collected and results were not analyzed.
Arm/Group Title Vapotherm-Heliox Standard Care
Arm/Group Description 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. 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. Care dictated by clinical team.
Measure Participants 0 0
5. Secondary Outcome
Title Length of Treatment With Supplemental Oxygen
Description
Time Frame During hospitalization, typically 4 days to 2 weeks

Outcome Measure Data

Analysis Population Description
Study was terminated early. Data were not collected and results were not analyzed.
Arm/Group Title Vapotherm-Heliox Standard Care
Arm/Group Description 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. 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. Care dictated by clinical team.
Measure Participants 0 0

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group Title Vapotherm-Heliox Standard Care
Arm/Group Description 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. 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. Care dictated by clinical team.
All Cause Mortality
Vapotherm-Heliox Standard Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN)
Serious Adverse Events
Vapotherm-Heliox Standard Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/6 (0%) 0/4 (0%)
Other (Not Including Serious) Adverse Events
Vapotherm-Heliox Standard Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/6 (0%) 0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Katherine Slain
Organization Case Western Reserve University
Phone 12168443310
Email katherine.slain@uhhospitals.org
Responsible Party:
Katherine Slain, DO, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT02373683
Other Study ID Numbers:
  • 06-14-08
First Posted:
Feb 27, 2015
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022