What this study is
Simplified from ClinicalTrials.govTesting a breath analyzer (MBP® Breath Analyzer) to see if it can collect measurable chemical signals from the breath of children ages 7 to 17 with signs or symptoms of sudden respiratory illness who come to the Masonic Children's Hospital pediatric emergency department. Healthy children there for minor injuries take part as comparisons.
Read the original summary from ClinicalTrials.gov
This pilot study will evaluate whether the MBP® Breath Analyzer can collect measurable volatile organic compound signals from pediatric participants with acute respiratory illness and from healthy pediatric controls.
Children aged 7 to 17 years presenting to the Masonic Children's Hospital Pediatric Emergency Department will be enrolled. One group will include participants with signs or symptoms of acute respiratory illness, and the control group will include participants presenting for minor injuries without respiratory symptoms.
Participants will breathe normally into the MBP® Breath Analyzer for approximately 1 minute. VOC signal data will be analyzed to assess device performance and to explore whether breath VOC patterns differ between pediatric participants with respiratory infection and healthy controls.
What's being tested
- MBP® Breath Analyzer
Intervention · DEVICE
The MBP® Breath Analyzer is a handheld breath sensor connected to a secure dedicated study mobile phone with the Vocxi app. A mask is connected to the device, and the participant breathes normally into the mask for approximately 1 minute. The system collects volatile organic compound signal data from exhaled breath for research analysis. The device will not be used to diagnose, treat, or guide clinical care.
Study details
- Official title
- Vocxi Breath Analyzer Study
- Sponsor
- University of Minnesota
- Conditions
- Acute Respiratory Illness · Viral Respiratory Infection
- Enrolling
- 20 people
- Starts
- 2026-10-27
- Est. completion
- 2027-03-01
- Design
- Open-label, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 7 Years – 17 YearsSex ALLHealthy volunteers AcceptedAcute Respiratory Illness Group
You may qualify if
- Age 7 to 17 years
- Able to participate in study procedures, including breathing comfortably into the MBP® Breath Analyzer for 1 minute
- Meets the case definition of acute respiratory illness, defined as two or more of the following signs or symptoms: fever, cough, runny nose, nasal congestion, or sore throat
You can't join if
- Unable to comfortably breathe normally into the MBP® Breath Analyzer for 1 minute
- Has eaten in the 30 minutes prior to use
- Has smoked in the 2 hours prior to use
- Primary diagnosis or parent concern in the Emergency Department is asthma or reactive airway disease
- History of or current cancer of any kind
- Current smoke inhalation injury
- Current concern for a drowning event
- Current concern for a drug overdose
- Requiring oxygen in the Emergency Department
- Current tracheostomy in place
- Non-English speaker
- Prisoner
- Active member of the military or DoD personnel
- Patient with research opt-out status in the medical record
- ESI score of 1 or 2
Control Group
You may qualify if
- Age 7 to 17 years
- Able to participate in study procedures, including breathing comfortably into the MBP® Breath Analyzer for 1 minute
- Does not have symptoms of acute respiratory illness
- Has not had symptoms of acute respiratory illness within the past month by parent or patient report
- Being seen in the Emergency Department for a minor injury, such as ankle sprain or laceration, with plan to discharge from the Emergency Department
You can't join if
- Unable to comfortably breathe normally into the MBP® Breath Analyzer for 1 minute
- Has eaten in the 30 minutes prior to use
- Has smoked in the 2 hours prior to use
- Primary diagnosis or parent concern in the Emergency Department is asthma or reactive airway disease
- History of or current cancer of any kind
- Current smoke inhalation injury
- Current concern for a drowning event
- Current concern for a drug overdose
- Requiring oxygen in the Emergency Department
- Current tracheostomy in place
- Non-English speaker
- Prisoner
- Active member of the military or DoD personnel
- Patient with research opt-out status in the medical record
- ESI score of 1 or 2
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Minnesota Masonic Children's Hospital Pediatric Emergency Department
Minneapolis, Minnesota, United States
- Gwenyth Fischer · Contact612-625-6678fisch662@umn.edu
Recruiting
Study team
Sponsor
University of Minnesota
Study ID PEDS-2026-34648
Principal investigator
Gwenyth Fischer
University of Minnesota
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.