Predicting High-Flow Nasal Cannula Failure in Acute Hypoxemic Respiratory Failure Using Metabolomics and Clinical Data

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital del Mar Research Institute (IMIM)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 1 trial group
Group A: Adult Patients With Acute Hypoxemic Respiratory Failure Treated With HFNC

Trial outcomes

Primary outcomes

1

HFNC Failure

Failure of high-flow nasal cannula (HFNC), defined as the need for invasive mechanical ventilation in patients with acute hypoxemic respiratory failure (AHRF).

Time frame
Within the first 28 days after HFNC initiation.

Secondary outcomes

1

Predictive Performance of the Metabolomic-Clinical Model

Comparison of the predictive accuracy of the metabolomic-clinical model versus the ROX index for predicting HFNC failure.

Time frame
Baseline and within the first 24 hours after HFNC initiation.

Other outcomes

1

ICU Mortality

All-cause mortality during ICU admission.

Time frame
Up to ICU discharge or 28 days.
2

Duration of Respiratory Support

Duration of HFNC therapy and invasive mechanical ventilation among patients requiring intubation.

Time frame
Up to 28 days.
3

Association Between Metabolomic Profiles and Clinical Phenotypes

Association between metabolomic biomarkers and clinical phenotypes according to sex, age, and etiology of acute hypoxemic respiratory failure.

Time frame
Baseline, day 3, and day 5.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital del Mar Research Institute (IMIM)

Lead sponsor

Instituto de Salud Carlos III

Collaborator

Fundació La Marató de TV3

Collaborator

Hospital Universitari de Bellvitge

Collaborator

Hospital Universitari Joan XXIII de Tarragona.

Collaborator

Parc Taulí Hospital Universitari

Collaborator

Institute for Bioengineering of Catalonia

Collaborator