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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vapotherm-Heliox | Experimental | 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. |
|
| Standard Care | No Intervention | Care dictated by clinical team. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vapotherm-Heliox | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre Rotta, MD | Rainbow Babies and Children's Hospital, University Hospitals Case Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rainbow Babies Children's Hospital, University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20399493 | Background | 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. | |
| 23509160 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Standard Care | Care dictated by clinical team. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Data was not collected or analyzed for enrolled patients.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data was not collected or analyzed. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Study was terminated early. Data were not collected and results were not analyzed. | Posted | 48 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Slain | Case Western Reserve University | 12168443310 | katherine.slain@uhhospitals.org |
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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| During hospitalization, typically 4 days to 2 weeks |
| Length of Treatment With Supplemental Oxygen | During hospitalization, typically 4 days to 2 weeks |
| Background |
| 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. |
| 11773543 | Background | 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. |
| 22147778 | Background | 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. |
| 15730610 | Background | 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. |
| 20393951 | Background | 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. |
| 22805160 | Background | 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. |
| 23900520 | Background | 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. |
| 23494016 | Background | 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. |
| 21369809 | Background | 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. |
| BG001 | Standard Care | Care dictated by clinical team. |
| BG002 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| months |
|
| Sex/Gender, Customized | Data was not collected or analyzed | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Primary diagnosis | Data was not collected or analyzed | Count of Participants | Participants |
|
| Standard Care |
Care dictated by clinical team. |
|
| Secondary | Need for Reintubation | Study was terminated early. Data were not collected and results were not analyzed. | Posted | During hospitalization, typically 4 days to 2 weeks |
|
|
| Secondary | PICU Length of Stay | Study was terminated early. Data were not collected and results were not analyzed. | Posted | During hospitalization, typically 4 days to 2 weeks |
|
|
| Secondary | Hospital Length of Stay | Study was terminated early. Data were not collected and results were not analyzed. | Posted | During hospitalization, typically 4 days to 2 weeks |
|
|
| Secondary | Length of Treatment With Supplemental Oxygen | Study was terminated early. Data were not collected and results were not analyzed. | Posted | During hospitalization, typically 4 days to 2 weeks |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Standard Care | Care dictated by clinical team. | 0 | 4 | 0 | 4 |
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| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |