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

February 14, 2021 updated by: Aykut Eşki, Ege University

Comparison of High Flow Nasal Cannula and Standard Face Mask Oxygen Therapy in Children With Moderate and Severe Bronchiolitis; a Randomized Controlled Trial

The study aims to compare the efficacy of two different oxygenation methods on decrease respiratory rate, heart rate, and clinical respiratory score in children with moderate to severe bronchiolitis requiring oxygen therapy.

  1. Standard face mask oxygen therapy (St-FMOT)
  2. High-flow nasal cannula oxygen therapy (HFNCOT)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 therapy (HFNCOT) has been widely used to provide respiratory support in children with acute respiratory diseases.

Patients had earlier improvement with HFNCOT to decrease the respiratory rate and respiratory effort than patients with standard low-flow oxygen therapy (SOT).

HFNCOT therapy reduced more effective in heart rate, respiratory effort, and length of supportive oxygen treatment (LOOT) compared with SOT. However, the length of hospital stay (LOS) and feeding ability had better consequences in patients with moderate and severe bronchiolitis treated with HFNCOT.

Another published study shows that in infants with acute bronchiolitis, which required oxygen therapy, there was no significant difference between therapy groups in terms of LOOT, LOS, and admission to the intensive care unit (ICU). HFNCOT was more efficient than SOT and reduced the rate of intubation/invasive ventilation in severe bronchiolitis management. Despite these beneficial effects of HFNCOT, 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

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Select A State
      • Izmir, Select A State, Turkey, 35100
        • Ege University Medical Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children aged between 1-24 months applied with moderate and severe bronchiolitis requiring supplemental oxygen were eligible for the study.
  • The severity of bronchiolitis was assessed according to the clinical respiratory score (CRS) of Liu et al. (5). The patients with CRS ≥5 were included.
  • Peripheral oxyhemoglobin saturation is < 92%.

Exclusion criteria:

  • Children admitted to the ICU for urgent invasive mechanical ventilation;
  • those who received standard oxygen therapy (SOT) or HFNCOT at other facilities before arrival;
  • those with an underlying medical condition (such as congenital heart disease, chronic lung disease, neuromuscular disease, metabolic disease, or immunocompromised);
  • those who had a craniofacial malformation, an upper airway obstruction, pneumothorax, or nasal trauma, and missing parental consent or a refused permission of the participant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Active Comparator: HFNCOT
Set between 2 to 25 l/min, adjusted to obtain peripheral oxygen saturation >92%.
Device: HFNCOT
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 to obtain the oxygen saturation >92%.
ACTIVE_COMPARATOR: Active Comparator: St-FMOT
To obtain oxygen saturation >92%
Other: St-FMOT
The inspired fraction of oxygen (FiO2) will be adjusted to obtain the oxygen saturation >92%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Taken to Reach the Normal Range for Heart Rate (Per-protocol Analysis)
Time Frame: through study completion, an average of 96 hours
The time that heart rate takes into the normal range for age between the groups (Per-protocol analysis).
through study completion, an average of 96 hours
Time Taken to Reach the Normal Range for Respiratory Rate (Per-protocol Analysis)
Time Frame: through study completion, an average of 96 hours
The time that the respiratory rate takes into the normal range for age between the groups (Per-protocol analysis).
through study completion, an average of 96 hours
Time Taken to Regress A Lower Clinical Respiratory Score (Per-protocol Analysis)
Time Frame: through study completion, an average of 96 hours
Unabbreviated scale title: Clinical Respiratory Score (Per-protocol analysis). The time that takes from severe bronchiolitis (9-12 points) to moderate bronchiolitis (5-8 points) or from moderate bronchiolitis (5-8 points) to mild bronchiolitis (0-4 points) between the groups. Higher scores mean a worse outcome. The score ranges from 0-12.
through study completion, an average of 96 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate (Intention-to-treat Analysis)
Time Frame: Baseline, 1,2,4,12,24,48,72 and 96 hours
Any differences in the time any recorded changes in heart rate from randomization to the patients' discharge within the groups and between the groups (Intention-to-treat analysis).
Baseline, 1,2,4,12,24,48,72 and 96 hours
Heart Rate (Per-protocol Analysis)
Time Frame: Baseline, 1,2,4,12,24,48,72 and 96 hours
Any differences in the time any recorded changes in heart rate from randomization to the patients' discharge within the groups and between the groups (Per-protocol analysis).
Baseline, 1,2,4,12,24,48,72 and 96 hours
Respiratory Rate (Intention-to-treat Analysis)
Time Frame: Baseline, 1,2,4,12,24,48,72 and 96 hours
Any differences in the time any recorded changes in respiratory rate from randomization to the patients' discharge within the groups and between the groups (Intention-to-treat analysis).
Baseline, 1,2,4,12,24,48,72 and 96 hours
Respiratory Rate (Per-protocol Analysis)
Time Frame: Baseline, 1,2,4,12,24,48,72 and 96 hours
Any differences in the time any recorded changes in respiratory rate from randomization to the patients' discharge within the groups and between the groups (Per-protocol analysis).
Baseline, 1,2,4,12,24,48,72 and 96 hours
Clinical Respiratory Score (Intention-to-treat Analysis)
Time Frame: Baseline, 1,2,4,12,24,48,72 and 96 hours

Unabbreviated scale title: Clinical Respiratory Score (Intention-to-treat analysis) Any differences in the time any recorded changes in the clinical respiratory score from randomization to the patients' discharge within the groups and between the groups.

This clinical respiratory score includes respiratory rate, retraction, dyspnea/consciousness status, and wheezing.

The severity of parameters is scored 0 to 3 points, and the patients with a clinical respiratory score of 0-4 points were defined as mild, moderate (5-8 points), and severe (9-12 point) bronchiolitis. Higher scores mean a worse outcome. The score ranges from 0-12.
Baseline, 1,2,4,12,24,48,72 and 96 hours
Clinical Respiratory Score (Per-protocol Analysis)
Time Frame: Baseline, 1,2,4,12,24,48,72 and 96 hours
Unabbreviated scale title: Clinical Respiratory Score (Per-protocol analysis). Any differences in the time any recorded changes in the clinical respiratory score from randomization to the patients' discharge within the groups and between the groups. This clinical respiratory score includes respiratory rate, retraction, dyspnea/consciousness status, and wheezing. The severity of parameters is scored 0 to 3 points, and the patients with a clinical respiratory score of 0-4 points were defined as mild, moderate (5-8 points), and severe (9-12 point) bronchiolitis. Higher scores mean a worse outcome. The score ranges from 0-12.
Baseline, 1,2,4,12,24,48,72 and 96 hours
Oxygen Requirement (Intention-to-treat Analysis)
Time Frame: through study completion, an average of 168 hours
The total duration of oxygen therapy (Intention-to-treat analysis).
through study completion, an average of 168 hours
Oxygen Requirement (Per-protocol Analysis)
Time Frame: through study completion, an average of 168 hours
The total duration of oxygen therapy (Per-protocol analysis).
through study completion, an average of 168 hours
Length of Hospital Stay (Intention-to-treat Analysis)
Time Frame: through study completion, an average of 168 hours
The time from randomization to the patient's discharge (Intention-to-treat analysis).
through study completion, an average of 168 hours
Length of Hospital Stay (Per-protocol Analysis)
Time Frame: through study completion, an average of 168 hours
The time from randomization to the patient's discharge (Per-protocol analysis).
through study completion, an average of 168 hours
Treatment Failure at 4 Hours (Intention-to-treat Analysis)
Time Frame: 4 hours
The number of treatment failures at 4 hours in each study arm (Intention-to-treat analysis).
4 hours
Pediatric Intensive Care Unit Admission (Intention-to-treat Analysis).
Time Frame: through study completion, an average of 168 hours
The number of participants admitted to the intensive care unit for invasive mechanical ventilation (Intention-to-treat analysis).
through study completion, an average of 168 hours
Adverse Events of Therapy (Intention-to-treat Analysis)
Time Frame: through study completion, an average of 168 hours
The number of participants with any adverse events in therapy groups (Intention-to-treat analysis).
through study completion, an average of 168 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Investigators

  • Principal Investigator: Aykut Eşki, MD, Ege University Medical Study

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 14, 2017

Primary Completion (ACTUAL)

March 10, 2020

Study Completion (ACTUAL)

March 10, 2020

Study Registration Dates

First Submitted

January 23, 2020

First Submitted That Met QC Criteria

January 25, 2020

First Posted (ACTUAL)

January 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 14, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-TIP-012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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