Predicting High-Flow Nasal Cannula Failure in Acute Hypoxemic Respiratory Failure Using Metabolomics and Clinical Data (META-RESPIRE)
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?
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Francisco José Parrilla-Gómez, MD, Phd
- Telefonnummer: +34 747424848
- E-post: fparilla@hmar.cat
Studera Kontakt Backup
- Namn: Joan Ramon Masclans Enviz, MD, PhD
- Telefonnummer: +34 639383309
- E-post: jrmasclans@hmar.cat
Studieorter
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Catalonia
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Barcelona, Catalonia, Spanien, 08003
- Rekrytering
- Hospital Del Mar
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Kontakt:
- Joan Ramon Masclans Enviz, MD, PhD
- Telefonnummer: +34 639383309
- E-post: jrmasclans@psmar.cat
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Kontakt:
- Marta Gas Roca
- Telefonnummer: +34 932483000
- E-post: mgas@psmar.cat
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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HFNC Failure
Tidsram: Within the first 28 days after HFNC initiation.
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Failure of high-flow nasal cannula (HFNC), defined as the need for invasive mechanical ventilation in patients with acute hypoxemic respiratory failure (AHRF).
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Within the first 28 days after HFNC initiation.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Predictive Performance of the Metabolomic-Clinical Model
Tidsram: Baseline and within the first 24 hours after HFNC initiation.
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Comparison of the predictive accuracy of the metabolomic-clinical model versus the ROX index for predicting HFNC failure.
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Baseline and within the first 24 hours after HFNC initiation.
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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ICU Mortality
Tidsram: Up to ICU discharge or 28 days.
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All-cause mortality during ICU admission.
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Up to ICU discharge or 28 days.
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Duration of Respiratory Support
Tidsram: Up to 28 days.
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Duration of HFNC therapy and invasive mechanical ventilation among patients requiring intubation.
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Up to 28 days.
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Association Between Metabolomic Profiles and Clinical Phenotypes
Tidsram: Baseline, day 3, and day 5.
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Association between metabolomic biomarkers and clinical phenotypes according to sex, age, and etiology of acute hypoxemic respiratory failure.
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Baseline, day 3, and day 5.
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Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Francisco José Parrilla-Gómez, MD, Phd, Hospital Del Mar
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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- 2025/12387/I
- PI25/00024 (Annat bidrag/finansieringsnummer: Instituto de Salud Carlos III)
- 202520-30-31 (Annat bidrag/finansieringsnummer: Fundació La Marató de TV3)
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