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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02373683

Enrollment

Registered

2015-02-27

Start date

2014-12-31

Completion date

2015-11-30

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis, Heliox, Pediatrics

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.

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.

Interventions

DEVICEVapotherm-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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 2 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Participant flow

Participants by arm

Arm	Count
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. 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.	6
Standard Care Care dictated by clinical team.	4
Total	10

Baseline characteristics

Characteristic	—	Total	Vapotherm-Heliox	Standard Care
Age, Continuous	— months	—	—	—
Primary diagnosis	—	0 Participants	0 Participants	0 Participants
Race and Ethnicity Not Collected	—	0 Participants	—	—
Sex/Gender, Customized	—	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 6	0 / 4
serious Total, serious adverse events	0 / 6	0 / 4

Outcome results

Primary

Respiratory Assessment Score

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