Predicting HFNC Failure in Acute Hypoxemic Respiratory Failure Using Metabolomics and Clinical Data (META-RESPIRE)

May 19, 2026 updated by: Andrea Castellvi, Hospital del Mar Research Institute (IMIM)

Metabolomics and Clinical Data to Predict High-Flow Nasal Cannula Failure and Optimize Respiratory Support in Acute Hypoxemic Respiratory Failure

The goal of this observational study is to determine whether metabolomic profiles combined with clinical data can predict high-flow nasal cannula (HFNC) failure and help optimize respiratory support in adult patients with acute hypoxemic respiratory failure (AHRF). The main questions it aims to answer are:

Can metabolomic biomarkers identify patients at higher risk of HFNC failure? Does combining metabolomic and clinical data improve the prediction of respiratory support escalation and clinical outcomes?

Participants will:

Receive standard HFNC treatment according to clinical practice. Undergo collection of clinical, physiological, and laboratory data. Provide blood samples for metabolomic analysis during respiratory support.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

This observational study aims to evaluate whether metabolomic signatures combined with routinely collected clinical and physiological data can improve the prediction of high-flow nasal cannula (HFNC) failure in patients with acute hypoxemic respiratory failure (AHRF). HFNC is widely used as first-line non-invasive respiratory support in AHRF; however, delayed recognition of treatment failure may lead to worse clinical outcomes, including delayed intubation and increased morbidity and mortality.

The study will prospectively enroll adult patients with AHRF treated with HFNC. Clinical variables, respiratory parameters, laboratory results, and patient outcomes will be collected during routine clinical care. Blood samples will also be obtained for metabolomic analysis to identify molecular profiles associated with HFNC success or failure.

The primary objective is to identify metabolomic and clinical predictors associated with HFNC failure and escalation of respiratory support. Secondary objectives include evaluating the association between metabolomic patterns and relevant clinical outcomes such as endotracheal intubation, duration of respiratory support, ICU length of stay, and mortality. The study also aims to develop predictive models integrating biological and clinical data to support personalized respiratory management strategies in AHRF.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Francisco José Parrilla-Gómez, MD, Phd
  • Phone Number: +34 747424848
  • Email: fparilla@hmar.cat

Study Contact Backup

  • Name: Joan Ramon Masclans Enviz, MD, PhD
  • Phone Number: +34 639383309
  • Email: jrmasclans@hmar.cat

Study Locations

  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain, 08003
        • Hospital Del Mar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients admitted to intensive care units (ICUs) with acute hypoxemic respiratory failure (AHRF) requiring treatment with high-flow nasal cannula (HFNC) as part of routine clinical care. Participants will be prospectively recruited from tertiary-care hospitals in Catalonia, Spain, including: Hospital del Mar, Hospital de Bellvitge, Hospital Parc Taulí, Hospital Joan XXIII

Description

Inclusion Criteria:

  • Adult patients (≥18 years old).
  • Admission to the intensive care unit (ICU) with acute hypoxemic respiratory failure (AHRF).
  • Treatment with high-flow nasal cannula (HFNC) as the initial respiratory support strategy.
  • Inclusion within the first 24 hours after HFNC initiation.
  • Provision of informed consent by the patient or legally authorized representative.

Exclusion Criteria:

  • Age <18 years.
  • Active do-not-resuscitate (DNR) orders or limitation of therapeutic effort.
  • Refusal or inability to provide informed consent.
  • Previous invasive mechanical ventilation before study inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Adult Patients With Acute Hypoxemic Respiratory Failure Treated With HFNC
Adult patients with acute hypoxemic respiratory failure receiving high-flow nasal cannula (HFNC) as part of routine clinical care. Clinical, physiological, and metabolomic data will be collected to evaluate predictors of HFNC failure and respiratory support escalation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HFNC Failure
Time Frame: Within the first 28 days after HFNC initiation.
Failure of high-flow nasal cannula (HFNC), defined as the need for invasive mechanical ventilation in patients with acute hypoxemic respiratory failure (AHRF).
Within the first 28 days after HFNC initiation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive Performance of the Metabolomic-Clinical Model
Time Frame: Baseline and within the first 24 hours after HFNC initiation.
Comparison of the predictive accuracy of the metabolomic-clinical model versus the ROX index for predicting HFNC failure.
Baseline and within the first 24 hours after HFNC initiation.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU Mortality
Time Frame: Up to ICU discharge or 28 days.
All-cause mortality during ICU admission.
Up to ICU discharge or 28 days.
Duration of Respiratory Support
Time Frame: Up to 28 days.
Duration of HFNC therapy and invasive mechanical ventilation among patients requiring intubation.
Up to 28 days.
Association Between Metabolomic Profiles and Clinical Phenotypes
Time Frame: Baseline, day 3, and day 5.
Association between metabolomic biomarkers and clinical phenotypes according to sex, age, and etiology of acute hypoxemic respiratory failure.
Baseline, day 3, and day 5.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital del Mar Research Institute (IMIM)

Collaborators

Hospital Universitari de Bellvitge
Instituto de Salud Carlos III
Hospital Universitari Joan XXIII de Tarragona.
Fundació La Marató de TV3
Institute for Bioengineering of Catalonia
Parc Taulí Hospital Universitari

Investigators

  • Principal Investigator: Francisco José Parrilla-Gómez, MD, Phd, Hospital Del Mar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 27, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

May 19, 2026

First Submitted That Met QC Criteria

May 19, 2026

First Posted (Actual)

May 26, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/12387/I
  • PI25/00024 (Other Grant/Funding Number: Instituto de Salud Carlos III)
  • 202520-30-31 (Other Grant/Funding Number: Fundació La Marató de TV3)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Both male and female participants will be included. Sex-specific metabolomic analyses will be explored as part of the study objectives.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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