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

November 24, 2023 updated by: Derşan Onur, Dr. Behcet Uz Children's Hospital

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

201

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
      • İzmir, Turkey
        • Dr Behcet Uz Children's Hospital

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

1 months-18 years Moderate to severe respiratory distress Oxygen therapy with high-flow nasal cannula

Description

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

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

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HFNC treatment outcome (failure or success)
Time Frame: 30 days
Whether advanced respiratory support treatments (invasive and noninvasive mechanical ventilation) are needed
30 days

Collaborators and Investigators

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

Sponsor

Dr. Behcet Uz Children's Hospital

Investigators

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

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)

October 1, 2018

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

November 19, 2023

First Submitted That Met QC Criteria

November 19, 2023

First Posted (Actual)

November 24, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 24, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HFNC failure

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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