An observational study in Acute Hypoxemic Respiratory Failure, sponsored by Hospital del Mar Research Institute (IMIM). Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Hospital del Mar Research Institute (IMIM) · Observational
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.
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, intensive care unit (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.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Hospital del Mar Research Institute (IMIM) is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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.
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.
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.
ICU Mortality
All-cause mortality during ICU admission.
Time frame: Up to ICU discharge or 28 days.
Duration of Respiratory Support
Duration of HFNC therapy and invasive mechanical ventilation among patients requiring intubation.
Time frame: Up to 28 days.
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.
Plan to share: Undecided — Both male and female participants will be included. Sex-specific metabolomic analyses will be explored as part of the study objectives.
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Hospital del Mar Research Institute (IMIM)