NCT05287958

Feasibility of an Electrical Impedance Tomography Device for Pulmonary Function Testing in ALS Patients

A Pilot Study on the Technical Feasibility of an Electrical Impedance Tomography Device for Quantitative Pulmonary Function Testing in ALS Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 58 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is an unblinded pilot study to investigate the technical feasibility of using an electrical impedance tomography device for noninvasive pulmonary function monitoring in ALS patients. The study will enroll patients with ALS in one cohort and healthy volunteers in a second cohort that will both undergo EIT imaging with the investigational device prior to and while performing a standard PFT procedure.

Detailed description

This is an unblinded pilot study to investigate the technical feasibility of using an electrical impedance tomography device for noninvasive pulmonary function monitoring in ALS patients. For both Cohort I and II, subject participation will require two visits (initial and 3-4 month follow up), which are expected to last approximately 30 minutes. Subjects will undergo EIT imaging with the investigational device prior to and while performing a standard PFT procedure. The actual EIT imaging will last for 10 to 15 minutes.

Conditions

• ALS

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	EIT	EIT comprises a chest belt that is connected to a computer via a universal serial bus (USB) or an Ethernet cable. The chest belt captures EIT data, which is transmitted via the USB or Ethernet cable to the computer. Tomography-like impedance images of the lungs are computed and displayed on the computer. The impedance images will be used to evaluate lung recruitment and other pulmonary function parameters that are currently measured using standard-of-care PFT devices.

Timeline

• Start date: 2021-07-15
• Primary completion: 2023-09-20
• Completion: 2023-09-20
• First posted: 2022-03-18
• Last updated: 2024-04-16

Locations

2 sites across 1 country: United States