Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry in Children and Adolescents
EBECA
1 other identifier
observational
3,600
1 country
1
Brief Summary
This study is to investigate breath analysis (breath metabolomics) combined with established bioinformatic tools as a platform for companion diagnostics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2020
CompletedFirst Posted
Study publicly available on registry
July 8, 2020
CompletedStudy Start
First participant enrolled
September 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2030
February 21, 2025
February 1, 2025
9.8 years
June 23, 2020
February 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Days of hospitalization
In the presentation of an acute disease the primary outcome will be days of hospitalization and its association with the exhaled breath pattern.
approx 30 days (from beginn hospitalisation to discharge date)
Change in Mass spectrometric profile of exhaled breath patterns
In the chronic presentation of the diseases, the mass spectrometric profile of exhaled breath patterns is analyzed
Week 0 (first regular clinic visit) to Follow-up visits (approx. years 1-10)
Change in Concentration of exhaled metabolites of pharmacotherapy
Concentration of exhaled metabolites of pharmacotherapy (breath metabolomics data)
Week 0 (first regular clinic visit) to Follow-up visits (approx. years 1-10)
Secondary Outcomes (5)
Identification of chemical structure of exhaled molecules (acetone, glucose)
approx 30 days (from begin hospitalisation to discharge date)
Correlations of identified molecules (acetone, glucose) in exhaled breath with body fluids (blood, saliva, urine) for T1D acute disease (mmol/l)
0h, 2h, 4h, 6h, 8h, 12h, 18h, 24h, 36h, 48h, 72h (h =hours after hospital admission)
Change in clinical endpoint lung function (Forced Expiratory Pressure in 1 Second FEV1 l/s) for correlation between clinical endpoint and the abundance of exhaled metabolites
approx 10 years (from begin hospitalisation to discharge date and from first regular clinic visit to Follow-up visits)
Change in clinical endpoint (body temperature, Celsius) for correlation between clinical endpoint and the abundance of exhaled metabolites
approx 10 years (from begin hospitalisation to discharge date and from first regular clinic visit to Follow-up visits)
Change in clinical endpoint (blood pressure, mmHg) for correlation between clinical endpoint and the abundance of exhaled metabolites
approx 10 years (from begin hospitalisation to discharge date and from first regular clinic visit to Follow-up visits)
Study Arms (12)
obstructive bronchitis/bronchiolitis
pneumonia
asthma
neurological diseases
type 1 diabetes (T1D)
pharmacotherapy with bronchodilators
pharmacotherapy with antibiotics
pharmacotherapy with antiviral medication
pharmacotherapy with antifungal medication
pharmacotherapy with antiepileptic medication
pharmacotherapy with immuno suppressants and immune-modulati
pharmacotherapy with anesthesia (including sedating, analges
Interventions
Participants will be asked to refrain from eating, drinking, chewing gum use or brushing their teeth at least 1 hour before the measurements will be performed. Room temperature and lighting will be set at the same level for all measurements. Participants will exhale through a disposable mouthpiece into a commercially available SESI source (FIT S.L., Spain). While performing full exhalations, the subjects will keep the pressure through the sampling line at a fixed value monitored by a digital manometer. Breath prints will be collected in real-time recording multiple replicates (typically six in positive and negative ion mode). The whole procedure is absolutely non-invasive and is usually accomplished without any effort in around 15 min per subject.
In young children below the age of 4 not capable of completing the on-line exhalation maneuvers, or in cases when the patient needs cannot approach the mass spectrometer, the sample will be collected off-line. They will be asked to exhale into a bag that will be transported to the lab and deflated into the mass spectrometer for analysis. Exhaled breath of patients under anesthesia will also collected using available ventilation system in the operation theatre.
Blood analysis done in patients who undergo regular blood sampling needed for clinical routine laboratory controls. This includes i) children and adolescents receiving medications which require TDM ii) patients with acute diseases such as TD1 and pneumonia and iii) patients with chronic diseases such as asthma bronchiale. For those patients where a blood sample is drawn during the clinical routine, an additional blood sample consisting of only several blood drops will be collected using the same blood sampling line. No additional venous puncture for research purpose will be done.
During the diagnostic and therapeutic work-up of T1D patients, saliva samples are collected during the clinical routine. For those patients, additional samples will be obtained by clinically trained investigators.
During the diagnostic and therapeutic work-up of T1D patients, urine samples are collected during the clinical routine. For those patients, additional samples will be obtained by clinically trained investigators.
Eligibility Criteria
Participants presenting with an acute disease in the emergency department at the University of Basel Children's Hospital (UKBB). Participants with chronic diseases recorded at the University of Basel Children's Hospital (UKBB).
You may qualify if:
- Age 0 ≤ 22 years at study entry and signed informed consent
- Acute disease: - Acute signs for a respiratory disease, indicated by e.g. increased work of breathing (e.g. dyspnea, increased respiratory rate), cough or wheezing.
- Chronic disease: - Suspected or confirmed chronic airway disease (e.g. asthma).
- Acute disease: - Acute presentation or report within 24 hours of any signs of neurological deficit (motor function, sensoneural, or verbal).
- Chronic disease: - Confirmed chronic neurologic disease (e.g. childhood epilepsy).
- Acute disease: - Hyperglycemia and/or pH (venous) \<7.3, bicarbonate \>10 mmol/L, increased levels of acetone in blood or urine in the context of newly diagnosed or known T1D.
- Chronic disease: - Confirmed diagnosis of T1D
You may not qualify if:
- Physical or intellectual impairment precluding protocol adherence.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Children's Hospital Basellead
- Swiss National Science Foundationcollaborator
- Fondation Botnar (Switzerland)collaborator
Study Sites (1)
University Children's Hospital Basel (UKBB)
Basel, 4031, Switzerland
Related Publications (1)
Zeng J, Stankovic N, Singh KD, Steiner R, Frey U, Erb T, Sinues P. Breath Analysis of Propofol and Associated Metabolic Signatures: A Pilot Study Using Secondary Electrospray Ionization-High-resolution Mass Spectrometry. Anesthesiology. 2025 Aug 1;143(2):345-356. doi: 10.1097/ALN.0000000000005531. Epub 2025 Apr 21.
PMID: 40258137DERIVED
Biospecimen
Blood samples will be divided into two sets and stored at -80°C in a dedicated, lock-secured laboratory freezer for later molecular analysis. One set will be used for blood plasma metabolomics. A second set will be analyzed depending on the exploratory findings regarding breath compounds. These samples shall enable retrospective correlation between the concentrations of molecules-of-interest in breath and blood. Saliva and urine samples will be divided in two sets and stored at -80°C in a dedicated, lock-secured laboratory freezer for later molecular analysis. One set will be used for metabolomics. A second set will be analyzed depending on the exploratory findings regarding breath compounds. These samples shall enable retrospective correlation between the concentrations of molecules-of-interest in breath and saliva.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pablo Sinues, Prof. Dr.
University Children's Hospital Basel, UKBB
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2020
First Posted
July 8, 2020
Study Start
September 11, 2020
Primary Completion (Estimated)
July 1, 2030
Study Completion (Estimated)
July 1, 2030
Last Updated
February 21, 2025
Record last verified: 2025-02