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

NCT06146439 | Completed

• 1 other identifier: HFNC failure
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

High-flow Nasal Cannula; Respiratory Distress; Treatment Failure

Keywords

Pediatric; HFNC; Respiratory distress; predictor of failure

Outcome Measures

Primary Outcomes (1)

• HFNC treatment outcome (failure or success)

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

  30 days

Study Arms (2)

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)

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Behcet Uz Children's Hospital: lead

Study Sites (1)

Dr Behcet Uz Children's Hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (3)

• Er A, Caglar A, Akgul F, Ulusoy E, Citlenbik H, Yilmaz D, Duman M. Early predictors of unresponsiveness to high-flow nasal cannula therapy in a pediatric emergency department. Pediatr Pulmonol. 2018 Jun;53(6):809-815. doi: 10.1002/ppul.23981. Epub 2018 Mar 12.

  PMID: 29528202 BACKGROUND

• Liu J, Li D, Luo L, Liu Z, Li X, Qiao L. Analysis of risk factors for the failure of respiratory support with high-flow nasal cannula oxygen therapy in children with acute respiratory dysfunction: A case-control study. Front Pediatr. 2022 Aug 23;10:979944. doi: 10.3389/fped.2022.979944. eCollection 2022.

  PMID: 36081624 BACKGROUND

• Sunkonkit K, Kungsuwan S, Seetaboot S, Reungrongrat S. Factors associated with failure of using high flow nasal cannula in children. Clin Respir J. 2022 Nov;16(11):732-739. doi: 10.1111/crj.13533. Epub 2022 Aug 29.

  PMID: 36038361 BACKGROUND

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Derşan Onur

  Dr. Behcet Uz Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: November 24, 2023
• Study Start: October 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: February 1, 2020
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

TU (1)