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

Respiratory Distress Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06146439
• Other study ID #: HFNC failure
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: February 1, 2020

Study information

• Verified date: November 2023
• Source: Dr. Behcet Uz Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: February 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• High-flow Nasal Cannula
• Respiratory Distress
• Treatment Failure

Locations

Country	Name	City	State
Turkey	Dr Behcet Uz Children's Hospital	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Behcet Uz Children's Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HFNC treatment outcome (failure or success)	Whether advanced respiratory support treatments (invasive and noninvasive mechanical ventilation) are needed	30 days