Clinical trial NCT06146439: The Factors Causing Treatment Failure in Children Receiving Oxygen Therapy With High-flow Nasal Cannula
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High-flow Nasal Cannula
Respiratory Distress
Treatment Failure
Keywords: Pediatric
HFNC
Respiratory distress
predictor of failure
Lead sponsor: Dr. Behcet Uz Children's Hospital
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 201
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1 months-18 years Moderate to severe respiratory distress Oxygen therapy with high-flow nasal cannula

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: HFNC treatment outcome (failure or success)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dr Behcet Uz Children's Hospital
Study officials:
affiliation: Dr. Behcet Uz Children's Hospital
name: Derşan Onur
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.