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

July 9, 2024 updated by: wang kaifei
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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The content of this study includes:

  1. Can EIT identify the uneven ventilation caused by airway contraction in patients during bronchial provocation tests.
  2. Can EIT monitor airway contraction in patients before Spirometer examination after inhaling activators.
  3. Can EIT observe uneven ventilation caused by airway contraction through tidal breathing after the patient inhales activator.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria：

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

Exclusion Criteria:

1. patients with a pre-bronchodilator FEV1≤60% predicted.

  1. Contraindications for bronchial challenge testing.
  2. Pregnant or lactating women.
  3. After pacemaker surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
global inhomogeneity index （GI）
Time Frame: 1day
Measured by EIT, used to describe the overall degree of spatial heterogeneity of ventilation.
1day
forced expiratory volume in 1s (FEV1)
Time Frame: 1day
The forced expiratory volume in 1s measured during pulmonary function tests.
1day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

wang kaifei

Investigators

  • Study Director: Fei Xie, Dr, Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

July 9, 2024

First Submitted That Met QC Criteria

July 9, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

July 9, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • EIT and PFTs

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Protocol and research data.

IPD Sharing Time Frame

Within 1 year after the publication of research results.

IPD Sharing Access Criteria

Can be obtained from the main researcher.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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