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Wearable Sweat Sensor for High-Concentration Lactate Monitoring in Critically Ill Patients

Development and Preliminary Clinical Validation of a Wearable Sweat Sensor for High-Concentration Lactate Monitoring in Critically Ill Patients: A Prospective Cohort Study

Blood lactate level is closely associated with the prognosis of patients with sepsis and septic shock. Clinical guidelines explicitly recommend blood lactate monitoring in septic patients and lactate-guided fluid resuscitation when lactate levels are elevated. Dynamic monitoring of serum lactate changes and calculation of lactate clearance can more accurately reflect the dynamic changes in tissue oxygen supply and consumption, and can be used to evaluate tissue perfusion and oxygen metabolism. However, most existing wearable sweat sensors have a detection range of only 0-20 mmol/L, which is suitable only for monitoring during exercise under normal physiological conditions and cannot meet the clinical monitoring needs of patients with hyperlactatemia. In addition, current wearable sweat lactate sensors suffer from poor reproducibility and are easily affected by environmental factors and complex sweat composition, which represent major obstacles to clinical translation. Therefore, this project aims to develop a wearable sweat sensor for high-concentration lactate monitoring and to conduct preliminary clinical validation in critically ill patients, by simultaneously measuring blood and sweat lactate concentrations and establishing their correlation, with the goal of achieving non-invasive and convenient disease monitoring through sweat biomarker detection.

Studieoversikt

Detaljert beskrivelse

Over the past decade, the wearable electronics industry has seen exponential growth in demand for continuous health monitoring technologies. From smartwatches to electronic skin, wearable devices have expanded their focus beyond biophysical signals to include biochemical signals such as small-molecule substances and macromolecular proteins in sweat. However, wearable sweat sensing technology still faces significant challenges, including discomfort and skin irritation caused by sweat-inducing materials, effective sweat extraction and collection capability, continuity and reliability of sweat sensing data, sensor calibration, and understanding of sweat analysis methods to discover clinically valuable new biomarkers. Therefore, how to translate wearable sweat monitoring devices into stable, continuous clinical use-matching the needs of health monitoring, disease diagnosis, and precision medicine-remains a research hotspot and challenge.

Lactate is abundant in sweat and is a hallmark product of anaerobic metabolism. Abnormal lactate levels are associated with multiple diseases. As an important marker of tissue perfusion, blood lactate level is closely associated with the prognosis of patients with severe sepsis and septic shock. Clinical guidelines explicitly recommend blood lactate monitoring in septic patients and lactate-guided fluid resuscitation when lactate levels are elevated. Dynamic monitoring of serum lactate changes and calculation of lactate clearance can more accurately reflect dynamic changes in tissue oxygen supply and consumption, and evaluate tissue perfusion and oxygen metabolism. Studies have shown that a lactate clearance rate ≥10% within 6 hours of resuscitation may predict lower mortality in septic patients. Clinical research has also shown that serum lactate concentration can be used to guide clinical treatment decisions, serving as both a therapeutic target and a prognostic indicator. However, most existing wearable sweat sensors have a detection limit of only 0-20 mmol/L, suitable only for exercise monitoring under normal physiological conditions, and cannot meet the clinical need for monitoring hyperlactatemia patients, whose lactate levels can reach up to 100 mmol/L. In addition, current wearable sweat lactate sensors suffer from poor reproducibility and are easily affected by environmental factors and complex sweat composition, posing major obstacles to clinical translation.

Based on this, the investigators have designed an intelligent wearable device for high-concentration sweat lactate monitoring, which includes a lactate detection electrode, a pH detection electrode, a temperature detection electrode, a sweat-stimulating electrode, a microfluidic sweat collection device, a hydrogel patch for inducing sweating, a flexible integrated circuit, and an intelligent display system. This wearable sweat lactate sensor achieves a detection range of up to 100 mmol/L, with a sensitivity of 89 nA/(cm²·mM) and a response time of 150 seconds, and achieves non-exercise-induced sweating through electrical stimulation. In addition, given the sensitivity of the lactate oxidase sensor to temperature and pH, corresponding temperature and pH sensors have been designed for calibration purposes.

This study is a prospective cohort study to be conducted in the surgical intensive care unit (ICU). Critically ill patients with blood lactate concentration >1.5 mmol/L will be enrolled and divided into two groups: (1) a sweat collection group, in which sweat will be collected using a commercial sweat collection device (HELA) for laboratory (ELISA) analysis; and (2) a wearable device monitoring group, in which patients will wear the investigator-designed wireless wearable sweat sensor for real-time monitoring. Clinical data, including medical history, imaging, and laboratory results, will be collected concurrently. The correlation between sweat and blood lactate concentrations, as well as the accuracy and safety of the wearable device, will be evaluated using Pearson correlation analysis.

Studietype

Observasjonsmessig

Registrering (Antatt)

86

Kontakter og plasseringer

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Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

N/A

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Critically ill patients admitted to the surgical intensive care unit (ICU) of the First Affiliated Hospital of Xi'an Jiaotong University with blood lactate concentration greater than 1.5 mmol/L, indicating hyperlactatemia associated with conditions such as sepsis or septic shock. Eligible patients will be assigned to either a sweat collection group or a wearable device monitoring group for concurrent measurement of blood and sweat lactate concentrations.

Beskrivelse

Inclusion Criteria:

  • Admitted to the surgical intensive care unit (ICU)
  • Blood lactate concentration > 1.5 mmol/L
  • Age ≥ 16 years
  • Willing to voluntarily donate samples and provide signed informed consent

Exclusion Criteria:

  • Pregnant women
  • Pre-existing hematologic disease prior to infection
  • Long-term use of immunosuppressive agents or presence of immunodeficiency
  • Skin too dry to allow adequate sweat collection

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Wearable Device Monitoring Group
A flexible wireless wearable device integrating a lactate detection electrode, pH detection electrode, temperature detection electrode, sweat-stimulating electrode, microfluidic sweat collection module, sweat-inducing hydrogel patch, and flexible integrated circuit with an intelligent display system. The device induces localized non-exercise sweating via electrical stimulation and enables real-time detection of sweat lactate concentration up to 100 mmol/L.
Sweat Collection Group
A commercially available sweat collection device (HELA) used to collect sweat samples from critically ill patients at the time of routine blood draws for clinical lactate testing. Collected sweat samples are subsequently analyzed for lactate concentration using ELISA in the laboratory.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sweat Lactate Concentration
Tidsramme: At the time of enrollment, concurrent with clinical blood lactate testing (within the ICU stay, up to approximately 12 months of enrollment period)
Sweat lactate concentration will be measured in critically ill patients with blood lactate concentration >1.5 mmol/L, either via laboratory (ELISA) analysis of sweat samples collected using a commercial sweat collection device, or via real-time detection using the investigator-designed wearable sweat sensor. The correlation between sweat and blood lactate concentrations will be analyzed using Pearson correlation to establish the sweat lactate concentration range corresponding to hyperlactatemia.
At the time of enrollment, concurrent with clinical blood lactate testing (within the ICU stay, up to approximately 12 months of enrollment period)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Correlation Between Sweat Lactate Concentration Measured by the Wearable Device and Blood Lactate Concentration Measured by Standard Clinical Testing
Tidsramme: Throughout the device-monitoring period during ICU stay (up to 12 months)
Sweat lactate concentration (mmol/L) obtained from the wearable device will be compared with corresponding blood lactate concentration (mmol/L) obtained through standard clinical laboratory testing, using correlation analysis (e.g., Pearson or Spearman correlation coefficient) and Bland-Altman agreement analysis.
Throughout the device-monitoring period during ICU stay (up to 12 months)
Number of Participants With Device-Related Skin Adverse Events
Tidsramme: Throughout the device-monitoring period during ICU stay (up to 12 months)
Number of participants experiencing skin irritation, discomfort, or other adverse events at the sensor application site, assessed through clinical observation during device use.
Throughout the device-monitoring period during ICU stay (up to 12 months)

Samarbeidspartnere og etterforskere

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

1. oktober 2028

Studiet fullført (Antatt)

1. oktober 2029

Datoer for studieregistrering

Først innsendt

13. juli 2026

Først innsendt som oppfylte QC-kriteriene

20. juli 2026

Først lagt ut (Faktiske)

21. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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