Predictive Model for High-Flow Nasal Cannula Failure in COVID-19-related Acute Hypoxemic Respiratory Failure Based on Metabolomics and Clinical Data

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

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-12-01

Brief Summary

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

The aim of this prospective observational cohort study is to develop a predictive model for high-flow nasal cannula (HFNC) failure in patients with acute hypoxemic respiratory failure (AHRF) caused by SARS-CoV-2. By combining clinical data and metabolomic profiles, the study seeks to answer:

\- Can integrating clinical parameters with metabolomic markers enhance the prediction of HFNC failure in AHRF patients?

Participants with AHRF due to SARS-CoV-2 receiving HFNC under standard-of-care protocols will be monitored until hospital discharge or death. Blood samples for metabolomic analysis will be collected at inclusion.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Predictors of Non-invasive Respiratory Support Failure in COVID-19 Pneumonia

NCT05094661

Noninvasive Ventilation Covid19 Distress; Respiratory Syndrome, Adult

COMPLETED NA

High Flow Nasal Therapy Versus Noninvasive Ventilation in COPD Exacerbation

NCT03370666

COPD Exacerbation

COMPLETED NA

HFNC and Acute Hypercapnic Respiratory Failure

NCT04109560

High Flow Oxygen Therapy Acute Hypercapnic Respiratory Failure COPD Exacerbation

COMPLETED

NIV in Covid-19 Respiratory Failure

NCT05020691

COVID-19 Pneumonia

TERMINATED

A Novel Index to Predict the Failure of High-flow Nasal Cannula in Patients with Acute Hypoxemic Respiratory Failure

NCT05549882

Acute Hypoxemic Respiratory Failure

COMPLETED

Detailed Description

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

This prospective observational cohort study focuses on developing and validating a predictive model for HFNC failure in patients with SARS-CoV-2-related AHRF, combining clinical parameters and metabolomic profiling. Patients received standard-of-care therapy based on hospital protocols, with clinical data and plasma samples collected at inclusion (T0) for laboratory and metabolomic analyses.

The study consists of two cohorts: a Training Cohort (March 2020 to April 2021) for model development and a Validation Cohort (May 2021 to October 2021) for model validation and external testing. HFNC outcomes were classified as success or failure, with failure defined as requiring orotracheal intubation (OTI). Advanced machine-learning techniques were employed for feature selection and model optimization, targeting precise integration of clinical and metabolomic data.

This model seeks to enhance early identification of HFNC failure risk, enabling timely interventions and personalized management in critically ill AHRF patients.

Conditions

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

Acute Hypoxemic Respiratory Failure COVID 19

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

PROSPECTIVE

Study Groups

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

Training Cohort

Participants included from March 2020 to April 2021 for model development.

No interventions assigned to this group

Validation Cohort

Participants included from May 2021 to October 2021 for model validation.

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

* Adult patients (≥18 years old) with acute hypoxemic respiratory failure (AHRF) confirmed as secondary to SARS-CoV-2 infection via PCR testing.
* Requirement for high-flow nasal cannula (HFNC) initiated within 48 hours of hospital admission.