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

Bronchiolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02373683
• Other study ID #: 06-14-08
• Status: Terminated
• Phase: N/A
• Start date: December 2014
• Est. completion date: November 2015

Study information

• Verified date: February 2022
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis
• Heliox
• Pediatrics

Intervention

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.

Locations

Country	Name	City	State
United States	Rainbow Babies Children's Hospital, University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Western Reserve University

Country where clinical trial is conducted

United States, 

References & Publications (10)

Abboud PA, Roth PJ, Skiles CL, Stolfi A, Rowin ME. Predictors of failure in infants with viral bronchiolitis treated with high-flow, high-humidity nasal cannula therapy*. Pediatr Crit Care Med. 2012 Nov;13(6):e343-9. doi: 10.1097/PCC.0b013e31825b546f. — View Citation

Bressan S, Balzani M, Krauss B, Pettenazzo A, Zanconato S, Baraldi E. High-flow nasal cannula oxygen for bronchiolitis in a pediatric ward: a pilot study. Eur J Pediatr. 2013 Dec;172(12):1649-56. doi: 10.1007/s00431-013-2094-4. Epub 2013 Jul 31. — View Citation

Chowdhury MM, McKenzie SA, Pearson CC, Carr S, Pao C, Shah AR, Reus E, Eliahoo J, Gordon F, Bland H, Habibi P. Heliox therapy in bronchiolitis: phase III multicenter double-blind randomized controlled trial. Pediatrics. 2013 Apr;131(4):661-9. doi: 10.1542/peds.2012-1317. Epub 2013 Mar 18. — View Citation

Gupta VK, Cheifetz IM. Heliox administration in the pediatric intensive care unit: an evidence-based review. Pediatr Crit Care Med. 2005 Mar;6(2):204-11. Review. — View Citation

Kim IK, Phrampus E, Sikes K, Pendleton J, Saville A, Corcoran T, Gracely E, Venkataraman S. Helium-oxygen therapy for infants with bronchiolitis: a randomized controlled trial. Arch Pediatr Adolesc Med. 2011 Dec;165(12):1115-22. doi: 10.1001/archpediatrics.2011.605. — View Citation

Liet JM, Ducruet T, Gupta V, Cambonie G. Heliox inhalation therapy for bronchiolitis in infants. Cochrane Database Syst Rev. 2010 Apr 14;(4):CD006915. doi: 10.1002/14651858.CD006915.pub2. Review. Update in: Cochrane Database Syst Rev. 2015;9:CD006915. — View Citation

Martinón-Torres F, Rodríguez-Núñez A, Martinón-Sánchez JM. Heliox therapy in infants with acute bronchiolitis. Pediatrics. 2002 Jan;109(1):68-73. — View Citation

Milési C, Baleine J, Matecki S, Durand S, Combes C, Novais AR, Cambonie G. Is treatment with a high flow nasal cannula effective in acute viral bronchiolitis? A physiologic study. Intensive Care Med. 2013 Jun;39(6):1088-94. doi: 10.1007/s00134-013-2879-y. Epub 2013 Mar 14. Erratum in: Intensive Care Med. 2013 Jun;39(6):1170. Combonie, Gilles [corrected to Cambonie, Gilles]. — View Citation

Nair H, Nokes DJ, Gessner BD, Dherani M, Madhi SA, Singleton RJ, O'Brien KL, Roca A, Wright PF, Bruce N, Chandran A, Theodoratou E, Sutanto A, Sedyaningsih ER, Ngama M, Munywoki PK, Kartasasmita C, Simões EA, Rudan I, Weber MW, Campbell H. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet. 2010 May 1;375(9725):1545-55. doi: 10.1016/S0140-6736(10)60206-1. Review. — View Citation

Schibler A, Pham TM, Dunster KR, Foster K, Barlow A, Gibbons K, Hough JL. Reduced intubation rates for infants after introduction of high-flow nasal prong oxygen delivery. Intensive Care Med. 2011 May;37(5):847-52. doi: 10.1007/s00134-011-2177-5. Epub 2011 Mar 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	48 hours
Secondary	Need for Reintubation		During hospitalization, typically 4 days to 2 weeks
Secondary	PICU Length of Stay		During hospitalization, typically 4 days to 2 weeks
Secondary	Hospital Length of Stay		During hospitalization, typically 4 days to 2 weeks
Secondary	Length of Treatment With Supplemental Oxygen		During hospitalization, typically 4 days to 2 weeks