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Recruiting NCT07607080

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

— Observational Acute Hypoxemic Respiratory Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acute Hypoxemic Respiratory Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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, 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.

Primary outcome measures

  • HFNC Failure [Time frame: Within the first 28 days after HFNC initiation.]
Secondary outcome measures (1)
  • Predictive Performance of the Metabolomic-Clinical Model [Time frame: Baseline and within the first 24 hours after HFNC initiation.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • Hospital del Mar — Barcelona

Publications

  • Masclans JR, Dot I, Perez-Teran P. High-Flow Nasal Cannulae. The Quest for the Holy Grail in the Critical Respiratory Patient? Arch Bronconeumol (Engl Ed). 2019 Jun;55(6):291-292. doi: 10.1016/j.arbres.2018.07.015. Epub 2018 Sep 6. No abstract available. English, Spanish. PMID 30195925
  • Blot PL, Chousterman BG, Santafe M, Cartailler J, Pacheco A, Magret M, Masclans JR, Artigas A, Roca O, Garcia-de-Acilu M. Subphenotypes in patients with acute respiratory distress syndrome treated with high-flow oxygen. Crit Care. 2023 Nov 1;27(1):419. doi: 10.1186/s13054-023-04687-0. PMID 37915062
  • Garcia-de-Acilu M, Marin-Corral J, Vazquez A, Ruano L, Magret M, Ferrer R, Masclans JR, Roca O. Hypoxemic Patients With Bilateral Infiltrates Treated With High-Flow Nasal Cannula Present a Similar Pattern of Biomarkers of Inflammation and Injury to Acute Respiratory Distress Syndrome Patients. Crit Care Med. 2017 Nov;45(11):1845-1853. doi: 10.1097/CCM.0000000000002647. PMID 28806218
  • Roca O, Caralt B, Messika J, Samper M, Sztrymf B, Hernandez G, Garcia-de-Acilu M, Frat JP, Masclans JR, Ricard JD. An Index Combining Respiratory Rate and Oxygenation to Predict Outcome of Nasal High-Flow Therapy. Am J Respir Crit Care Med. 2019 Jun 1;199(11):1368-1376. doi: 10.1164/rccm.201803-0589OC. PMID 30576221
  • Manrique S, Claverias L, Magret M, Masclans JR, Bodi M, Trefler S, Canadell L, Diaz E, Sole-Violan J, Bisbal-Andres E, Natera RG, Moreno AA, Vallverdu M, Ballesteros JC, Socias L, Vidal FG, Sancho S, Martin-Loeches I, Rodriguez A. Timing of intubation and ICU mortality in COVID-19 patients: a retrospective analysis of 4198 critically ill patients during the first and second waves. BMC Anesthesiol. PMID 37106321
  • Molano-Franco D, Viruez-Soto A, Gomez M, Beltran E, Villabon M, Sosa A, Ortiz L, Orozco E, Hurtado A, Sanchez L, Arias-Reyes C, Soliz J, Masclans JR. Impact of High-Flow Nasal Cannula Use in Subjects With COVID-19 ARDS at High Altitudes: Clinical Presentation and Prognostic Factors. Respir Care. 2023 Dec 28;69(1):99-105. doi: 10.4187/respcare.10839. PMID 37311630
  • Parrilla-Gomez FJ, Marin-Corral J, Castellvi-Font A, Perez-Teran P, Picazo L, Ravelo-Barba J, Campano-Garcia M, Festa O, Restrepo M, Masclans JR. Switches in non-invasive respiratory support strategies during acute hypoxemic respiratory failure: Need to monitoring from a retrospective observational study. Med Intensiva (Engl Ed). 2024 Apr;48(4):200-210. doi: 10.1016/j.medine.2023.11.006. Epub 2023 PMID 37985338
  • Madrid-Gambin F, Oller S, Marco S, Pozo OJ, Andres-Lacueva C, Llorach R. Quantitative plasma profiling by 1H NMR-based metabolomics: impact of sample treatment. Front Mol Biosci. 2023 Jun 2;10:1125582. doi: 10.3389/fmolb.2023.1125582. eCollection 2023. PMID 37333016

Identifiers

NCT: NCT07607080 · 2025/12387/I · PI25/00024 · 202520-30-31

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗