Research on the Application of Electrical Impedance Tomography in Bronchial Challenge Testing

NCT06502405 | Not Yet Recruiting

• 1 other identifier: EIT and PFTs
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to examine whether electrical impedance tomography (EIT) was capable of identifying the deteriorated lung function on a regional level during bronchial challenge testing and whether EIT may provide additional information during bronchial challenge testing and identify spatial and temporal heterogeneity of regional lung function.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• global inhomogeneity index （GI）

  Measured by EIT, used to describe the overall degree of spatial heterogeneity of ventilation.

  1day

• forced expiratory volume in 1s (FEV1)

  The forced expiratory volume in 1s measured during pulmonary function tests.

  1day

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients need to exclude or confirm a suspected diagnosis of asthma through bronchial challenge testing.

You may qualify if:

• Patients suspected of asthma who require bronchial challenge testing.
• The Bronchodilator responsiveness testing is negative.
• patients with a pre-bronchodilator FEV1 \>60% predicted.
• No contraindications for bronchial provocation test examination.
• Fully understand the purpose and significance of this study, and voluntarily participate in the research.

You may not qualify if:

• \. patients with a pre-bronchodilator FEV1≤60% predicted.
• Contraindications for bronchial challenge testing.
• Pregnant or lactating women.
• After pacemaker surgery.

Sponsors & Collaborators

• wang kaifei: lead

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Fei Xie, Dr

  Chinese PLA General Hospital

  STUDY DIRECTOR

Central Study Contacts

Lu Cao, Master

CONTACT

13810389517; caolu301@163.om

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy chief physician

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 16, 2024
• Study Start: August 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within 1 year after the publication of research results.
• Access Criteria: Can be obtained from the main researcher.