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Completed

NCT Number: NCT04245202

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

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)

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Key information

Conditions

Acute Bronchiolitis

Age range

1 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University Medical Faculty

Izmir, Select A State, 35100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HFNCOT

Device

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%.

St-FMOT

Other

The inspired fraction of oxygen (FiO2) will be adjusted to obtain the oxygen saturation >92%.

Primary outcomes

  1. 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).

  2. 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).

  3. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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.

  6. 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.

  7. 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).

  8. Oxygen Requirement (Per-protocol Analysis)

    Time frame: through study completion, an average of 168 hours

    The total duration of oxygen therapy (Per-protocol analysis).

  9. 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).

  10. 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).

  11. 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).

  12. 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).

  13. 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).

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 28, 2020
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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