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
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.
- Conventional oxygen therapy (O2 Simple face mask)
- 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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: Active Comparator: HFNC group
Set between 2 to 25 l/min, adjusted to obtain oxygen saturation >92%.
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
- 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
- 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
- Oxyhemoglobin saturation [ Time Frame: through study completion, an average of 1 year ]The duration that oxyhemoglobin saturation at the admission increase to >92%
- Oxygen requirement [ Time Frame: through study completion, an average of 1 year ]Total duration of oxygen therapy
- Length of hospital stay day [ Time Frame: through study completion, an average of 1 year ]Length of hospital stay day
- 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.
- 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)
- 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
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
|Contact: Aykut Eşki, MDfirstname.lastname@example.org|
|Contact: Gökçen Kartal Öztürk, MDemail@example.com|
|Principal Investigator:||Aykut Eşki, MD||Ege University Medical Study|