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

E

Ege University

Status

Completed

Conditions

Acute Bronchiolitis

Treatments

Device: HFNCOT
Other: St-FMOT

Study type

Interventional

Funder types

Other

Identifiers

NCT04245202
17-TIP-012

Details and patient eligibility

About

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)

Full 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.

Enrollment

87 patients

Sex

All

Ages

1 to 24 months old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

87 participants in 2 patient groups

Active Comparator: HFNCOT
Active Comparator group
Description:
Set between 2 to 25 l/min, adjusted to obtain peripheral oxygen saturation \>92%.
Treatment:
Device: HFNCOT
Active Comparator: St-FMOT
Active Comparator group
Description:
To obtain oxygen saturation \>92%
Treatment:
Other: St-FMOT

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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