Clinical trial NCT02373683: Helium-oxygen Gas Mixtures Delivered by a High Flow Nasal Cannula in Bronchiolitis
Official title: Helium-oxygen Gas Mixtures Delivered by a High Flow Nasal Cannula in Bronchiolitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bronchiolitis
Heliox
Pediatrics
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 10
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Respiratory Assessment Score
timeFrame: 48 hours
Secondary outcomes:
measure: Need for Reintubation
timeFrame: During hospitalization, typically 4 days to 2 weeks
measure: PICU Length of Stay
timeFrame: During hospitalization, typically 4 days to 2 weeks
measure: Hospital Length of Stay
timeFrame: During hospitalization, typically 4 days to 2 weeks
measure: Length of Treatment With Supplemental Oxygen
timeFrame: During hospitalization, typically 4 days to 2 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Rainbow Babies Children's Hospital, University Hospitals Case Medical Center
state: Ohio
Study officials:
affiliation: Rainbow Babies and Children's Hospital, University Hospitals Case Medical Center
name: Alexandre Rotta, MD
role: PRINCIPAL_INVESTIGATOR
References:
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, Simoes 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.
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.
citation: Martinon-Torres F, Rodriguez-Nunez A, Martinon-Sanchez JM. Heliox therapy in infants with acute bronchiolitis. Pediatrics. 2002 Jan;109(1):68-73. doi: 10.1542/peds.109.1.68.
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.
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. doi: 10.1097/01.PCC.0000154946.62733.94.
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.
citation: 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.
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.
citation: Milesi 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.
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.