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

NCT07607080 | Recruiting

• 3 other identifiers: 2025/12387/IPI25/00024202520-30-31
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Hypoxemic Respiratory Failure

Keywords

Acute Hypoxemic Respiratory Failure (AHRF); High-Flow Nasal Cannula (HFNC); Metabolomics; Respiratory Failure Prediction; Noninvasive Respiratory Support

Outcome Measures

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).

  Within the first 28 days after HFNC initiation.

Secondary Outcomes (1)

• Predictive Performance of the Metabolomic-Clinical Model

  Baseline and within the first 24 hours after HFNC initiation.

Other Outcomes (3)

• ICU Mortality

  Up to ICU discharge or 28 days.

• Duration of Respiratory Support

  Up to 28 days.

• Association Between Metabolomic Profiles and Clinical Phenotypes

  Baseline, day 3, and day 5.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.
• Provision of informed consent by the patient or legally authorized representative.

You may not qualify if:

• Age \<18 years.
• Active do-not-resuscitate (DNR) orders or limitation of therapeutic effort.
• Refusal or inability to provide informed consent.

Sponsors & Collaborators

• Hospital del Mar Research Institute (IMIM): lead
• 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

Study Sites (1)

Hospital del Mar

Barcelona, Catalonia, 08003, Spain

RECRUITING

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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. 2023 Apr 27;23(1):140. doi: 10.1186/s12871-023-02081-5.

  PMID: 37106321 BACKGROUND

• 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 BACKGROUND

• 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 Nov 18.

  PMID: 37985338 BACKGROUND

• 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 BACKGROUND

• Gomez-Gomez A, Rodriguez-Morato J, Haro N, Marin-Corral J, Masclans JR, Pozo OJ. Untargeted detection of the carbonyl metabolome by chemical derivatization and liquid chromatography-tandem mass spectrometry in precursor ion scan mode: Elucidation of COVID-19 severity biomarkers. Anal Chim Acta. 2022 Mar 1;1196:339405. doi: 10.1016/j.aca.2021.339405. Epub 2022 Jan 4.

  PMID: 35151400 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood, Plasma

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Francisco José Parrilla-Gómez, MD, Phd

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco José Parrilla-Gómez, MD, Phd

CONTACT

+34 747424848; fparilla@hmar.cat

Joan Ramon Masclans Enviz, MD, PhD

CONTACT

+34 639383309; jrmasclans@hmar.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: June 4, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

ES (1)