Acute Hypoxemic Respiratory FailureMETA-RESPIRENCT07607080
Predicting High-Flow Nasal Cannula Failure in Acute Hypoxemic Respiratory Failure Using Metabolomics and Clinical Data
An observational study of Acute Hypoxemic Respiratory Failure, run by Hospital del Mar Research Institute (IMIM) at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 4 Jun 2026to May 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital del Mar
Barcelona, Catalonia, 08003
Joan Ramon Masclans Enviz, MD, PhD, +34 639383309, jrmasclans@psmar.cat
Marta Gas Roca, +34 932483000, mgas@psmar.cat
About this study
Official title: Metabolomics and Clinical Data to Predict High-Flow Nasal Cannula Failure and Optimize Respiratory Support in Acute Hypoxemic Respiratory Failure
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?
Read more
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.
Read the 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.
- Conditions
- Acute Hypoxemic Respiratory Failure
- Keywords
- Acute Hypoxemic Respiratory Failure (AHRF), High-Flow Nasal Cannula (HFNC), Metabolomics, Respiratory Failure Prediction, Noninvasive Respiratory Support
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline and within the first 24 hours after HFNC initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start4 Jun 2026
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Acute Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital del Mar Research Institute (IMIM)
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Fundació La Marató de TV3, Hospital Universitari de Bellvitge, Hospital Universitari Joan XXIII de Tarragona., Parc Taulí Hospital Universitari, Institute for Bioengineering of Catalonia
- Responsible party
- Principal investigator, Andrea Castellvi, Hospital del Mar Research Institute (IMIM)
- Investigators
- Francisco José Parrilla-Gómez, MD, Phd, Principal investigator, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607080
- Sponsor's protocol ID
- 2025/12387/I
- Other IDs
- PI25/00024, 202520-30-31, 2025
- Acronym
- META-RESPIRE
- Status last verified
- Jun 2026
- First submitted
- 19 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Both male and female participants will be included. Sex-specific metabolomic analyses will be explored as part of the study objectives.
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.
PubMed 30195925Blot 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.
PubMed 37915062Garcia-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.
PubMed 28806218Roca 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.
PubMed 30576221Manrique 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.
PubMed 37106321Molano-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.
PubMed 37311630Parrilla-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.
PubMed 37985338Madrid-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.
PubMed 37333016Gomez-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.
PubMed 35151400