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Completed

NCT Number: NCT06146439

The Factors Causing Treatment Failure in Children Receiving Oxygen Therapy With High-flow Nasal Cannula

The goal of this observational study is to identify the variables that predict treatment failure in order to identify the patients in which HFNC treatment may fail and not delay the transition to advanced respiratory support treatments in these patients.

The main questions it aims to answer are:

* What factors contribute to the failure of HFNC treatment in these children? * What is the frequency of HFNC treatment failure in children with moderate and severe respiratory distress? Researchers will compare the group whose HFNC treatment was successful with the group whose HFNC treatment failed to identify factors that cause treatment failure.

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr Behcet Uz Children's Hospital

Izmir, Turkey (Türkiye)

About this study

Oxygen therapy with a high-flow nasal cannula (HFNC) is a well-tolerated, relatively new, non-invasive alternative ventilation treatment modality. On the other hand, HFNC failure delays advanced respirator supportive treatments, prolongs hospitalization in the intensive care unit, and emergency department, and causes a significant increase in morbidity and mortality with hypoxemia, neurological impairment, and/or hemodynamic instability. The investigators aimed to identify the variables that predict treatment failure in order to identify the patients in which HFNC treatment may fail and not delay the transition to advanced respiratory support treatments in these patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Moderate to severe respiratory distress
  • Oxygen therapy with high-flow nasal cannula

Exclusion criteria

  • Chronic lung disease (those with CO2 retention or hypoxia in their daily life)
  • Cyanotic congenital heart disease
  • Craniofacial malformation
  • Trauma patients
  • Hypotonic patients
  • Cases with tracheostomy
  • Patients using HFNC therapy for respiratory support after extubation

Treatment and study plan

Primary outcomes

  1. HFNC treatment outcome (failure or success)

    Time frame: 30 days

    Whether advanced respiratory support treatments (invasive and noninvasive mechanical ventilation) are needed

Sponsors and collaborators

Lead sponsor

Dr. Behcet Uz Children's Hospital

Other

Registry information

Official study title

Determination of the Factors Causing Treatment Failure in Children Receiving Oxygen Therapy With High-flow Nasal Cannula Due to Moderate and Severe Respiratory Distress

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 24, 2023
Registry last updated
Nov 29, 2023

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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