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

Sponsor
Dr. Behcet Uz Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06146439
Collaborator
(none)
201
1
16
12.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    201 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official 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
    Actual Study Start Date :
    Oct 1, 2018
    Actual Primary Completion Date :
    Jan 1, 2020
    Actual Study Completion Date :
    Feb 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Successful

    Patients who do not need advanced respiratory support treatments (invasive and noninvasive mechanical ventilation)

    Failure

    Patients who need advanced respiratory support treatments (invasive and noninvasive mechanical ventilation)

    Outcome Measures

    Primary Outcome Measures

    1. HFNC treatment outcome (failure or success) [30 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dr Behcet Uz Children's Hospital İzmir Turkey

    Sponsors and Collaborators

    • Dr. Behcet Uz Children's Hospital

    Investigators

    • Principal Investigator: Derşan Onur, Dr. Behcet Uz Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Derşan Onur, Principal Investigator, Dr. Behcet Uz Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT06146439
    Other Study ID Numbers:
    • HFNC failure
    First Posted:
    Nov 24, 2023
    Last Update Posted:
    Nov 29, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Derşan Onur, Principal Investigator, Dr. Behcet Uz Children's Hospital

    Study Results

    No Results Posted as of Nov 29, 2023