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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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.
Other outcomes
ICU Mortality
All-cause mortality during ICU admission.
Duration of Respiratory Support
Duration of HFNC therapy and invasive mechanical ventilation among patients requiring intubation.
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.
Sponsors and contacts
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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