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

NCT ID: NCT06146439

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

201 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

High-flow Nasal Cannula Respiratory Distress Treatment Failure

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Pediatric HFNC Respiratory distress predictor of failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Successful

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

No interventions assigned to this group

Failure

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dr. Behcet Uz Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Derşan Onur

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Derşan Onur

Role: PRINCIPAL_INVESTIGATOR

Dr. Behcet Uz Children's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dr Behcet Uz Children's Hospital

Izmir, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29528202 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36081624 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36038361 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HFNC failure

Identifier Type: -

Identifier Source: org_study_id