Clinical trial NCT02793674: HFNC Flow Titration and Effort of Breathing in the PICU
Official title: High-Flow Nasal Cannula Flow Titration and Effort of Breathing in the Pediatric Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Flow Nasal Cannula
Keywords: effort of breathing
high flow nasal cannula
respiratory distress
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2016-06-08
Enrollment: 21
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: High-flow nasal cannula (HFNC) is a method of non-invasive respiratory support used to decrease the effort of breathing (EOB) in patients with a wide variety of respiratory diseases in the pediatric intensive care unit. While its use has shown association with decreased rates of mechanical ventilation, there is a paucity of data examining its direct effect upon objective measurements of EOB. This study will aim to evaluate objective measurements of EOB in response to different levels of HFNC support, characterize the natural course of respiratory diseases treated with HFNC, evaluate changes in EOB secondary to the administration of supplemental medical therapies used in conjunction with HFNC, and compare different physiologic metrics for quantifying EOB in patients on HFNC.


Eligibility criteria: Inclusion Criteria:

* All participants less than or equal to three years old admitted to the PICU placed on high flow nasal cannula will be considered eligible for the study.

Exclusion Criteria:

* Participants will be excluded if they have a corrected gestational age less than 37 weeks or contraindications to nasoesophageal catheter placement (nasopharyngeal or esophageal abnormalities) or RIP bands (abdominal wall defects such as omphalocele). Patients greater than three years of age will be excluded.

Primary outcomes:
measure: Percent Change in Pressure-rate Product (PRP) as a Function of Increasing HFNC Flow Rate on Both Types of HFNC Delivery System (FP and VT)
timeFrame: median percent change in PRP over 5 minute measurement period
Secondary outcomes:
measure: Pressure-rate Product (PRP) as a Function of Increasing HFNC Flow Rate on Both Types of HFNC Delivery System (FP and VT)
timeFrame: median PRP over a 5 minute period
measure: Phase Angle as a Function of Increasing HFNC Flow Rate on Both Types of HFNC Delivery System (FP and VT)
timeFrame: median phase angle over a 5 minute period
measure: Percent Change in Pressure-rate Product (PRP) From Baseline as a Function of Increasing HFNC Flow Rate, Comparing Different HFNC Delivery Systems
timeFrame: median PRP over a 5 minute period
measure: Percent Change in Pressure-rate Product (PRP) From Baseline as a Function of Increasing HFNC Flow Rate, Comparing Weight-Stratified Subgroups on Both Types of HFNC Delivery System (FP and VT)
timeFrame: medain percent change in PRP over a 5 minute period
measure: Maximum Percent Change in Pressure-rate Product (PRP) From Baseline as a Function of Increasing HFNC Flow Rate, Comparing Weight-Stratified Subgroups on Both Types of HFNC Delivery System (FP and VT)
timeFrame: median of the maximum percent change in PRP over a 5 minute period
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
References:
citation: Lee JH, Rehder KJ, Williford L, Cheifetz IM, Turner DA. Use of high flow nasal cannula in critically ill infants, children, and adults: a critical review of the literature. Intensive Care Med. 2013 Feb;39(2):247-57. doi: 10.1007/s00134-012-2743-5. Epub 2012 Nov 10.
citation: McKiernan C, Chua LC, Visintainer PF, Allen H. High flow nasal cannulae therapy in infants with bronchiolitis. J Pediatr. 2010 Apr;156(4):634-8. doi: 10.1016/j.jpeds.2009.10.039. Epub 2009 Dec 29.
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.
citation: Wing R, James C, Maranda LS, Armsby CC. Use of high-flow nasal cannula support in the emergency department reduces the need for intubation in pediatric acute respiratory insufficiency. Pediatr Emerg Care. 2012 Nov;28(11):1117-23. doi: 10.1097/PEC.0b013e31827122a9.
citation: Frizzola M, Miller TL, Rodriguez ME, Zhu Y, Rojas J, Hesek A, Stump A, Shaffer TH, Dysart K. High-flow nasal cannula: impact on oxygenation and ventilation in an acute lung injury model. Pediatr Pulmonol. 2011 Jan;46(1):67-74. doi: 10.1002/ppul.21326. Epub 2010 Nov 23.
citation: Lavizzari A, Veneroni C, Colnaghi M, Ciuffini F, Zannin E, Fumagalli M, Mosca F, Dellaca RL. Respiratory mechanics during NCPAP and HHHFNC at equal distending pressures. Arch Dis Child Fetal Neonatal Ed. 2014 Jul;99(4):F315-20. doi: 10.1136/archdischild-2013-305855. Epub 2014 Apr 30.
citation: Bellani G, Pesenti A. Assessing effort and work of breathing. Curr Opin Crit Care. 2014 Jun;20(3):352-8. doi: 10.1097/MCC.0000000000000089.
citation: Bekhof J, Reimink R, Brand PL. Systematic review: insufficient validation of clinical scores for the assessment of acute dyspnoea in wheezing children. Paediatr Respir Rev. 2014 Mar;15(1):98-112. doi: 10.1016/j.prrv.2013.08.004. Epub 2013 Oct 11.
citation: Klein M, Reynolds LG. Relief of sleep-related oropharyngeal airway obstruction by continuous insufflation of the pharynx. Lancet. 1986 Apr 26;1(8487):935-9. doi: 10.1016/s0140-6736(86)91043-3.
citation: Collett PW, Perry C, Engel LA. Pressure-time product, flow, and oxygen cost of resistive breathing in humans. J Appl Physiol (1985). 1985 Apr;58(4):1263-72. doi: 10.1152/jappl.1985.58.4.1263.
citation: KRIEGER I, WHITTEN CF. WORK OF RESPIRATION IN BRONCHIOLITIS. Am J Dis Child. 1964 Apr;107:386-92. doi: 10.1001/archpedi.1964.02080060388010. No abstract available.
citation: Stokes GM, Milner AD, Groggins RC. Work of breathing, intra-thoracic pressure and clinical findings in a group of babies with bronchiolitis. Acta Paediatr Scand. 1981 Sep;70(5):689-94. doi: 10.1111/j.1651-2227.1981.tb05769.x.
citation: Allen JL, Wolfson MR, McDowell K, Shaffer TH. Thoracoabdominal asynchrony in infants with airflow obstruction. Am Rev Respir Dis. 1990 Feb;141(2):337-42. doi: 10.1164/ajrccm/141.2.337.
citation: Mayfield S, Bogossian F, O'Malley L, Schibler A. High-flow nasal cannula oxygen therapy for infants with bronchiolitis: pilot study. J Paediatr Child Health. 2014 May;50(5):373-8. doi: 10.1111/jpc.12509. Epub 2014 Feb 25.
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: Rubin S, Ghuman A, Deakers T, Khemani R, Ross P, Newth CJ. Effort of breathing in children receiving high-flow nasal cannula. Pediatr Crit Care Med. 2014 Jan;15(1):1-6. doi: 10.1097/PCC.0000000000000011.
citation: Ritchie JE, Williams AB, Gerard C, Hockey H. Evaluation of a humidified nasal high-flow oxygen system, using oxygraphy, capnography and measurement of upper airway pressures. Anaesth Intensive Care. 2011 Nov;39(6):1103-10. doi: 10.1177/0310057X1103900620.
citation: Lampland AL, Plumm B, Meyers PA, Worwa CT, Mammel MC. Observational study of humidified high-flow nasal cannula compared with nasal continuous positive airway pressure. J Pediatr. 2009 Feb;154(2):177-82. doi: 10.1016/j.jpeds.2008.07.021. Epub 2008 Aug 30.
citation: Glezen P, Denny FW. Epidemiology of acute lower respiratory disease in children. N Engl J Med. 1973 Mar 8;288(10):498-505. doi: 10.1056/NEJM197303082881005. No abstract available.
citation: Hartling L, Bialy LM, Vandermeer B, Tjosvold L, Johnson DW, Plint AC, Klassen TP, Patel H, Fernandes RM. Epinephrine for bronchiolitis. Cochrane Database Syst Rev. 2011 Jun 15;(6):CD003123. doi: 10.1002/14651858.CD003123.pub3.
citation: Gadomski AM, Scribani MB. Bronchodilators for bronchiolitis. Cochrane Database Syst Rev. 2014 Jun 17;2014(6):CD001266. doi: 10.1002/14651858.CD001266.pub4.
citation: Numa AH, Williams GD, Dakin CJ. The effect of nebulized epinephrine on respiratory mechanics and gas exchange in bronchiolitis. Am J Respir Crit Care Med. 2001 Jul 1;164(1):86-91. doi: 10.1164/ajrccm.164.1.2008090.
citation: Sanchez I, De Koster J, Powell RE, Wolstein R, Chernick V. Effect of racemic epinephrine and salbutamol on clinical score and pulmonary mechanics in infants with bronchiolitis. J Pediatr. 1993 Jan;122(1):145-51. doi: 10.1016/s0022-3476(05)83508-5.
citation: Willson DF, Horn SD, Hendley JO, Smout R, Gassaway J. Effect of practice variation on resource utilization in infants hospitalized for viral lower respiratory illness. Pediatrics. 2001 Oct;108(4):851-5. doi: 10.1542/peds.108.4.851.
citation: Green M, Brayer AF, Schenkman KA, Wald ER. Duration of hospitalization in previously well infants with respiratory syncytial virus infection. Pediatr Infect Dis J. 1989 Sep;8(9):601-5. doi: 10.1097/00006454-198909000-00007.
citation: Wang EE, Law BJ, Stephens D. Pediatric Investigators Collaborative Network on Infections in Canada (PICNIC) prospective study of risk factors and outcomes in patients hospitalized with respiratory syncytial viral lower respiratory tract infection. J Pediatr. 1995 Feb;126(2):212-9. doi: 10.1016/s0022-3476(95)70547-3.