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Assessment of an Exhaled Breath Test to Detect Bronchiectasis

NCT05293314 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 544

Last updated 2024-11-19

Study results available
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Summary

To investigate whether the breath test is able to detect bronchiectasis using breathomics. This study was conducted with a prospective specimen collection, evaluator-blinded, case-controlled clinical study designed to evaluate the accuracy of breathomics to diagnosis of bronchiectasis in adults.

Conditions

Interventions

DIAGNOSTIC_TEST

An exhaled breath test

All exhaled breath samples were collected by trained investigators following the same protocol. All participants fasted for at least 6 hours before breath collection. To reduce potential confounding factors, all participants were asked to not ingest spicy food, alcohol, or coffee the night before exhaled breath collection. Exhaled breath was collected in Tedlar air bags (DuPont de Nemours). The night before breath collection, the Tedlar bags were baked at 60 °C for 3 hours to fully release possible contaminants and continuously purged with high-purity nitrogen 4 times. Participants first gargled with pure water and then performed a single deep nasal inhalation followed by complete exhalation via their mouth into Tedlar bags. A total of 1000 mL of exhaled breath was collected from each participant. Breath sample detection was based on the HPPI-TOFMS platform.

Sponsors & Collaborators

  • Shanghai Pulmonary Hospital, Shanghai, China

    lead OTHER

Principal Investigators

  • Jin-fu Xu, MD · Department of Respiratory and Critical Care

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2023-05-01
Completion
2023-05-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05293314 on ClinicalTrials.gov