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NCT Number: NCT06695442

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

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.

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Key information

Conditions

Acute Hypoxemic Respiratory Failure COVID 19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital del Mar

Barcelona, Spain, 08003

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • Patients under the age of 18
  • Patients with active "do not resuscitate" (DNR) orders at the time of inclusion.

Treatment and study plan

Primary outcomes

  1. Predictive Model Development

    Time frame: From the initiation of HFNC until the need for intubation, hospital discharge, or death, whichever occurs first (up to 28 days). Completed using the Training Cohort (March 2020 to April 2021).

    Area Under the Receiver Operating Characteristic Curve (AUC) of the final predictive model for identifying HFNC failure, measured at the time of study inclusion (T0).

Secondary outcomes

  1. Identification of Key Metabolites

    Time frame: At study inclusion (T0).

    Concentrations of key metabolomic markers (e.g., anthranilic acid, octanoic acid) associated with HFNC failure, measured at T0.

  2. Validation of the Predictive Model

    Time frame: From the initiation of HFNC until the need for intubation, hospital discharge, or death, whichever occurs first (up to 28 days). Completed during the Validation Cohort phase (May to October 2021).

    Performance of the predictive model in the Validation Cohort. Area Under the Receiver Operating Characteristic Curve (AUC) of the final predictive model for identifying HFNC failure, measured at the time of study inclusion (T0).

Sponsors and collaborators

Lead sponsor

Hospital del Mar Research Institute (IMIM)

Other

Collaborators

  • European Union
  • Fundacio La Marató de TV3
  • Instituto de Salud Carlos III

Registry information

Official study title

Predictive Model for High-Flow Nasal Cannula Failure Based on Metabolomics and Clinical Data: COVID-19 As a Use Case

Acronym: COVIDOMICS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2024
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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