Breath Analysis of Propofol and Associated Metabolic Signatures: A Pilot Study Using Secondary Electrospray Ionization-High-resolution Mass Spectrometry.
Jiafa Zeng, Nikola Stankovic, Kapil Dev Singh...
https://pubmed.ncbi.nlm.nih.gov/40258137Actively Recruiting
Age: 0 - 22Years
All Genders
ID04461821
Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry in Children and Adolescents (EBECA)
Led by University Children's Hospital Basel · Updated on 2026-05-08
3600
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Children's Hospital Basel
Lead Sponsor
S
Swiss National Science Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating breath analysis combined with advanced bioinformatic tools to develop companion diagnostics in children and adolescents. This research aims to improve therapeutic drug monitoring by including drug-related metabolites in addition to drug concentrations, offering a more personalized approach to treatment. The study focuses on conditions such as respiratory diseases, neurological disorders, and type 1 diabetes in patients up to 22 years old. The study uses a Secondary Electrospray Ionization - Mass Spectrometry (SESI-MS) platform to capture disease-related and drug-related metabolites in exhaled breath. Participants will provide breath samples either through real-time exhalation into the SESI device or off-line collection for young children or patients under anesthesia. Additional biological samples including blood, saliva, and urine may be collected during routine clinical visits to correlate with breath metabolite profiles. Participants will be monitored through regular clinic visits over several years, with assessments including hospitalization duration, changes in breath metabolite patterns, and correlations with clinical endpoints such as lung function, body temperature, and blood pressure. The procedure is non-invasive, with breath collection typically taking about 15 minutes. Researchers will analyze the breath and biological samples to better understand internal biochemical processes and optimize therapeutic management.
CONDITIONS
Brief Title
Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry in Children and Adolescents
Who Can Participate
Age: 0 - 22Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 0 to 22 years at study entry with signed informed consent
- For respiratory diseases: acute signs like increased work of breathing, cough, or wheezing, or suspected/confirmed chronic airway disease such as asthma
- For neurological diseases: acute neurological symptoms within 24 hours or confirmed chronic neurological disease such as epilepsy
- For type 1 diabetes: acute hyperglycemia, pH below 7.3, bicarbonate above 10 mmol/L, increased acetone levels, or confirmed diagnosis of type 1 diabetes
You will not qualify if you...
- Physical or intellectual impairment preventing adherence to the study protocol
- For respiratory diseases: known malignancy, active smoking, inflammatory diseases requiring treatment, relevant congenital defects
- For neurological diseases: known malignancy, active smoking, inflammatory diseases requiring treatment, relevant congenital defects
- For type 1 diabetes: known malignancy, active smoking, relevant congenital defects
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Ongoing during clinical visits
Participants undergo non-invasive exhaled breath analysis using Secondary Electrospray Ionization - Mass Spectrometry (SESI-MS) and may provide blood, saliva, and urine samples during routine clinical care for analysis of metabolites and biochemical markers.
1 or more visits depending on clinical routine and participant age
Long-term Monitoring
Duration - Up to 10 years
Participants are monitored over time with follow-up visits to assess changes in exhaled breath metabolite profiles and clinical endpoints, potentially up to 10 years.
Follow-up visits approximately yearly or as per clinical routine
Trial Site Locations
Total: 1 location
1
University Children's Hospital Basel (UKBB)
Basel, Switzerland, 4031
Actively Recruiting
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Research Team
P
Pablo Sinues, Prof. Dr.
M
Mélina Richard
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
12
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