Using HFNC in Bronchiolitis

NCT03342781 | Completed

• 1 other identifier: 2016/504
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators compared oxygen therapy using the HFNC and diffuser mask (an effective low-flow oxygen delivery system) to treat patients with moderate-to-severe acute bronchiolitis admitted to an intensive care unit (ICU).

Conditions

Respiratory Failure; Bronchiolitis

Keywords

bronchiolitis; diffuser mask; high-flow nasal oxygen; pediatric intensive-care unit

Outcome Measures

Primary Outcomes (1)

• presence of treatment failure

  Treatment failure was defined as meeting two of the following criteria \[16\]: 1. No change or an increase in respiration rate compared with baseline. 2. No change or an increase in heart rate compared with baseline. 3. Persistence of low SpO2 (\<%92) measurements despite an adequate oxygen flow rate and FiO2 in the HFNC group/oxygen flow rate of 15 L/min in the mask group.

  up to 1 month

Secondary Outcomes (3)

• total duration of oxygen therapy

  up to 1 month

• Length of hospital stay day

  up to 1 month

• time of treatment failure

  up to 1 month

Study Arms (2)

Diffuser-mask group

ACTIVE COMPARATOR

The patients received oxygen therapy (8-15 L/min) from an OxyMask (Southmedic, Inc., Barrie, ON, Canada) to maintain oxygen saturation (SpO2) \> 92%. Oxygen therapy was halted if SpO2 was maintained at a level greater than 92% for more than 4 h. The oxygen flow rate was then decreased to 2 L/min and the patient was monitored while breathing room air.

Device: Diffuser oxygen mask

HFNC group

ACTIVE COMPARATOR

The patients received oxygen therapy at a high flow rate from a Precision Flow nasal cannula (Vapotherm, Inc., Stevensville, MD, USA). We selected a 1.9 mm pediatric cannula, which can dispense 1-20 L/min of oxygen. The initial oxygen flow rate was 1 L/kg/min and the FiO2 was 100%. The initial flow rate was increased by 1 L/kg/min until the SpO2 reached 92%. The initial FiO2 was decreased once the SpO2 was greater than 92% and the oxygen flow rate was maintained. HFNC therapy was halted if SpO2 was maintained at a level greater than 92% for more than 4 h at a FiO2 value of 21%, and the patient was transferred to a ward.

Device: high flow nasal oxygen therapy

Interventions

high flow nasal oxygen therapy DEVICE

Oxygen therapy using a high-flow nasal cannula (HFNC) is a high-flow oxygen delivery system that enhances the efficiency of respiration by using high flow rates to clear dead space and provide fresh oxygen. This system supplies oxygen at a high flow rate through a loose nasal cannula.

HFNC group

Diffuser oxygen mask DEVICE

diffuser mask is a low-flow delivery system, which is capable of delivering up to 90% of the fraction of inspired oxygen (FiO2) with low CO2 retention. In this system, the FiO2 can be adjusted by modifying the flow velocity to deliver the quantity of oxygen that the patient requires. Oxygen is supplied to the patient in a jet that flows from a device mounted on the oxygen mask. This ensures that a high concentration of oxygen is provided at a low flow rate.

Diffuser-mask group

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Included patients were aged between 1 and 24 months and had been diagnosed with moderate or severe acute bronchiolitis. They were admitted to the ICU, requiring supplemental oxygen, because their SpO2 measurements were less than 94% while breathing room air.

You may not qualify if:

• Any patients requiring immediate respiratory support (non-invasive or invasive mechanical ventilation, altered mental status, or apnea at presentation), those already admitted to the ICU due to respiratory failure, those with underlying chronic lung disease or cardiovascular disorders, those with obstructions of the upper respiratory tract, and those with cranial malformations were excluded.

Sponsors & Collaborators

• Kayseri Training and Research Hospital: lead

Related Publications (11)

• Tapiainen T, Aittoniemi J, Immonen J, Jylkka H, Meinander T, Nuolivirta K, Peltola V, Salo E, Seuri R, Walle SM, Korppi M. Finnish guidelines for the treatment of laryngitis, wheezing bronchitis and bronchiolitis in children. Acta Paediatr. 2016 Jan;105(1):44-9. doi: 10.1111/apa.13162. Epub 2015 Nov 6.

  PMID: 26295564 BACKGROUND

• Kose S, Sehriyaroglu A, Esen F, Ozdemir A, Kardas Z, Altug U, Karakus E, Ozcan A, Kisaarslan AF, Elmali F, Torun YA, Kose M. Comparing the Efficacy of 7%, 3% and 0.9% Saline in Moderate to Severe Bronchiolitis in Infants. Balkan Med J. 2016 Mar;33(2):193-7. doi: 10.5152/balkanmedj.2016.16840. Epub 2016 Mar 1.

  PMID: 27403389 BACKGROUND

• Paul JE, Hangan H, Hajgato J. The OxyMask() development and performance in healthy volunteers. Med Devices (Auckl). 2009;2:9-17. Epub 2008 Dec 11.

  PMID: 22915909 BACKGROUND

• Beecroft JM, Hanly PJ. Comparison of the OxyMask and Venturi mask in the delivery of supplemental oxygen: pilot study in oxygen-dependent patients. Can Respir J. 2006 Jul-Aug;13(5):247-52. doi: 10.1155/2006/720320.

  PMID: 16896425 BACKGROUND

• Ling E, McDonald L, Dinesen TR, DuVall D. The OxyArm - a new minimal contact oxygen delivery system for mouth or nose breathing. Can J Anaesth. 2002 Mar;49(3):297-301. doi: 10.1007/BF03020531.

  PMID: 11861350 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.

  PMID: 23900520 BACKGROUND

• Pham TM, O'Malley L, Mayfield S, Martin S, Schibler A. The effect of high flow nasal cannula therapy on the work of breathing in infants with bronchiolitis. Pediatr Pulmonol. 2015 Jul;50(7):713-20. doi: 10.1002/ppul.23060. Epub 2014 May 21.

  PMID: 24846750 BACKGROUND

• Hough JL, Pham TM, Schibler A. Physiologic effect of high-flow nasal cannula in infants with bronchiolitis. Pediatr Crit Care Med. 2014 Jun;15(5):e214-9. doi: 10.1097/PCC.0000000000000112.

  PMID: 24705569 BACKGROUND

• Keenan SP, Sinuff T, Cook DJ, Hill NS. Does noninvasive positive pressure ventilation improve outcome in acute hypoxemic respiratory failure? A systematic review. Crit Care Med. 2004 Dec;32(12):2516-23. doi: 10.1097/01.ccm.0000148011.51681.e2.

  PMID: 15599160 BACKGROUND

• ten Brink F, Duke T, Evans J. High-flow nasal prong oxygen therapy or nasopharyngeal continuous positive airway pressure for children with moderate-to-severe respiratory distress?*. Pediatr Crit Care Med. 2013 Sep;14(7):e326-31. doi: 10.1097/PCC.0b013e31828a894d.

  PMID: 23842586 BACKGROUND

• Ralston SL, Lieberthal AS, Meissner HC, Alverson BK, Baley JE, Gadomski AM, Johnson DW, Light MJ, Maraqa NF, Mendonca EA, Phelan KJ, Zorc JJ, Stanko-Lopp D, Brown MA, Nathanson I, Rosenblum E, Sayles S 3rd, Hernandez-Cancio S; American Academy of Pediatrics. Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis. Pediatrics. 2014 Nov;134(5):e1474-502. doi: 10.1542/peds.2014-2742.

  PMID: 25349312 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Bronchiolitis

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 17, 2017
• Study Start: March 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11