Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of High Flow Nasal Cannula and Standard Face Mask Oxygen Treatment in Children With Acute Bronchiolitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04245202
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Aykut Eşki, Ege University

Brief Summary:

The aim of the study is to compare, in patients with acute moderate and severe bronchiolitis the efficacy of two different methods of oxygenation to decrease respiratory rate, heart rate, bronchiolitis severity score and, provides rapid improvement oxygenation.

  1. Conventional oxygen therapy (O2 Simple face mask)
  2. High flow nasal oxygen therapy (O2-HFN)

Condition or disease Intervention/treatment Phase
Acute Bronchiolitis Device: HFNC-O2 Other: Simple Face Mask O2 Not Applicable

Detailed Description:

Bronchiolitis is the most common cause of hospitalization for children under one year of age and, caused by respiratory viruses. Although several medications and interventions studied for bronchiolitis treatment, hydration and oxygenation are the main treatments. High-flow nasal cannula oxygen (HFNC-O2) has been widely used to provide respiratory support in children with acute respiratory diseases. Patients had earlier improvement with HFNC-O2 treatment to decrease the respiratory rate and respiratory effort compared to patients with standard low-flow oxygen (sLF-O2).

HFNC-O2 therapy reduced more effective in heart rate, respiratory effort and length of supportive oxygen treatment compared to patients with standard low-flow therapy. However, the length of hospital stay and feeding ability had better consequences in patients with moderate and severe bronchiolitis treated with HFNC-O2.

Another published study shows that in infants with acute bronchiolitis which required oxygen therapy was not found a significant difference between HFNC-O2 and sLF-O2, in terms of the length of supportive oxygen and hospitalization, and admission to the pediatric intensive care unit (PICU). HFNC-O2 therapy was more efficient than sLF-O2 and reduced the rate of intubation/invasive ventilation in acute severe bronchiolitis management. Despite these beneficial effects of HFNC-O2, it was not recommended by international guidelines yet. However, well designed, prospective randomized controlled trials are still needed to use this therapy in the wards.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of High Flow Nasal Cannula and Standard Face Mask Oxygen Treatment in Children With Acute Moderate and Severe Bronchiolitis; a Randomized Controlled Trial (TURKEY Study)
Actual Study Start Date : March 14, 2017
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Active Comparator: Active Comparator: HFNC group
Set between 2 to 25 l/min, adjusted to obtain oxygen saturation >92%.
Device: HFNC-O2
The patient will receive a high flow nasal of humidified oxygen, set between 2 to 25 l/min. The inspired fraction of oxygen (FiO2) will be adjusted in order to obtain the oxygen saturation >92%.

Active Comparator: Active Comparator: Simple Face Mask
To obtain oxygen saturation >92%
Other: Simple Face Mask O2
Standard low flow therapy




Primary Outcome Measures :
  1. Heart rate [ Time Frame: through study completion, an average of 1 year ]
    The duration that heart rate at the admission change to normal range according to the patient's age

  2. Respiratory rate [ Time Frame: through study completion, an average of 1 year ]
    The duration that respiratory rate at the admission change to normal range according to the patient's age

  3. Oxyhemoglobin saturation [ Time Frame: through study completion, an average of 1 year ]
    The duration that oxyhemoglobin saturation at the admission increase to >92%


Secondary Outcome Measures :
  1. Oxygen requirement [ Time Frame: through study completion, an average of 1 year ]
    Total duration of oxygen therapy

  2. Length of hospital stay day [ Time Frame: through study completion, an average of 1 year ]
    Length of hospital stay day

  3. Decreased bronchiolitis severity score [ Time Frame: through study completion, an average of 1 year ]
    the time that takes for the bronchiolitis severity score (Respiratory clinical score by Liu et al.) to change from 9-12 points to 5-8 points or to change from 5-8 points to 0-4 points. Respiratory clinical score includes respiratory rate, retractions, dyspnea, and auscultation.

  4. Pediatric intensive care unit admission [ Time Frame: through study completion, an average of 1 year ]
    Number of participants admitted to PICU due to not tolerated the oxygen therapy (Standard O2 or HFNC-O2)

  5. Adverse effect of therapy [ Time Frame: through study completion, an average of 1 year ]
    Number of participants with any adverse effect of standard and/or HFNC-O2



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children aged between 1-24 months presenting the emergency department or admitted to the ward were eligible for inclusion if they had been diagnosed bronchiolitis according to the American Academy of Pediatrics clinical practice guidelines.
  • The severity of bronchiolitis was assessed according to the bronchiolitis severity score (BSS) of Liu et al. (5). The patients with BSS ≥5 were included.
  • Oxyhemoglobin saturation is < 92%.

Exclusion Criteria:

  • Infants who required invasive ventilation or PICU admission and/or had a pneumothorax/nasal trauma and/or craniofacial anomalies and/or coexisting bacterial pneumonia and/or any comorbid diseases (congenital heart disease, chronic lung disease, neuro-metabolic disease, and immunodeficiency or immunocompromised) were excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04245202


Contacts
Layout table for location contacts
Contact: Aykut Eşki, MD 05303009760 aykuteski1984@gmail.com
Contact: Gökçen Kartal Öztürk, MD 05447291376 gokcen_kartal@hotmail.com

Locations
Layout table for location information
Turkey
Ege University Medical Faculty Recruiting
Izmir, Select A State, Turkey, 35100
Contact: Aykut Eşki, MD    05303009760    aykuteski1984@gmail.com   
Contact: Gökçen Kartal Öztürk, MD    05447291376    gokcen_kartal@hotmail.com   
Sponsors and Collaborators
Ege University
Investigators
Layout table for investigator information
Principal Investigator: Aykut Eşki, MD Ege University Medical Study

Publications of Results:

Layout table for additonal information
Responsible Party: Aykut Eşki, Medical Doctor, Pediatric Pulmonology, Ege University
ClinicalTrials.gov Identifier: NCT04245202    
Other Study ID Numbers: 17-TIP-012
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aykut Eşki, Ege University:
Acute Bronchiolitis
High Flow Nasal Cannula
Standard Face Mask
Additional relevant MeSH terms:
Layout table for MeSH terms
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections