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Using HFNC in Bronchiolitis

Primary Purpose

Respiratory Failure, Bronchiolitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
high flow nasal oxygen therapy
Diffuser oxygen mask
Sponsored by
Kayseri Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring bronchiolitis, diffuser mask, high-flow nasal oxygen, pediatric intensive-care unit

Eligibility Criteria

1 Month - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Diffuser-mask group

    HFNC group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    presence of treatment failure
    Treatment failure was defined as meeting two of the following criteria [16]: No change or an increase in respiration rate compared with baseline. No change or an increase in heart rate compared with baseline. 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.

    Secondary Outcome Measures

    total duration of oxygen therapy
    Length of hospital stay day
    time of treatment failure

    Full Information

    First Posted
    November 2, 2017
    Last Updated
    November 14, 2017
    Sponsor
    Kayseri Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03342781
    Brief Title
    Using HFNC in Bronchiolitis
    Official Title
    Using a High-flow Nasal Cannula Provided Superior Results to Diffuser Delivery in Severe Bronchiolitis: a Prospective, Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2016 (undefined)
    Primary Completion Date
    December 1, 2016 (Actual)
    Study Completion Date
    March 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kayseri Training and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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).
    Detailed Description
    Acute bronchiolitis results from inflammation of the bronchioles and is usually caused by a viral infection. It is most common in children younger than 2 years old and is one of the most frequent reasons why a child is admitted to hospital. There is no established, specific therapy for acute bronchiolitis and it is commonly treated using supplemental oxygen and by ensuring that the patient remains hydrated. Oxygen therapy can be applied using a low- or high-flow oxygen delivery system. For example, a diffuser mask (OxyMask) is a low-flow delivery system, which is capable of delivering up to 90% of the fraction of inspired oxygen (FiO2) with low carbon dioxide (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. Additionally, CO2 retention is minimal because the mask has a fenestrated structure. Therefore, a diffuser mask is a more effective oxygen delivery method than many other low-flow delivery systems including the nasal cannula and simple oxygen mask. 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 therapy provides heated and humidified oxygen to fill the dead space in the nasopharynx and produces minimal positive airway pressure. It enhances the passage of air through the airway by reducing inspiratory pressure. Previous studies have demonstrated that using a HFNC can decrease respiratory effort and improve gas exchange. In recent years, many studies have suggested that high-flow nasal oxygen therapy is more effective than low-flow systems. This is substantiated by significant decreases in the use of mechanical ventilation since HFNC therapy was introduced. Previous reports on the effectiveness of HFNC therapy in treating acute bronchiolitis have come primarily from observational work and there are few relevant, randomized controlled studies. Additionally, previous studies have compared HFNC therapy with less effective, low-flow systems (e.g., the simple mask or nasal cannula). To the best of our knowledge, no randomized controlled trial has compared the effectiveness of the HFNC and diffuser mask in treating bronchiolitis. In this study, 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Failure, Bronchiolitis
    Keywords
    bronchiolitis, diffuser mask, high-flow nasal oxygen, pediatric intensive-care unit

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Diffuser-mask group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    HFNC group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    high flow nasal oxygen therapy
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Diffuser oxygen mask
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    presence of treatment failure
    Description
    Treatment failure was defined as meeting two of the following criteria [16]: No change or an increase in respiration rate compared with baseline. No change or an increase in heart rate compared with baseline. 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.
    Time Frame
    up to 1 month
    Secondary Outcome Measure Information:
    Title
    total duration of oxygen therapy
    Time Frame
    up to 1 month
    Title
    Length of hospital stay day
    Time Frame
    up to 1 month
    Title
    time of treatment failure
    Time Frame
    up to 1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Month
    Maximum Age & Unit of Time
    24 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.

    12. IPD Sharing Statement

    Citations:
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