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The feasibility of using Electrical Impedance Tomography to determine mechanics of ventilation in comparison to standard clinical parameters in patients with high spinal injury T8 and above

The feasibility of using Electrical Impedance Tomography to determine mechanics of ventilation in comparison to standard clinical parameters in patients with high spinal injury T8 and above

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12623001213639
Enrollment
30
Registered
2023-11-24
Start date
2024-03-01
Completion date
2026-06-30
Last updated
2023-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The general aim of this pilot study is to establish correlations between parameters of electrical impedance tomography with standard clinical parameters. The specific aims are to: 1.Assess lung ventilation distribution in patients with high spinal injuries (T8 and above) 2.Collect clinical data on ventilatory mechanics including level of spinal deficits, ventilatory mechanics (invasive, non-invasive, ventilator settings) intraabdominal pressure, FiO2 ratio, and end tidal CO2 to arterial CO2 gap 3.Assess correlation between EIT parameters and clinical data Validity and reliability of EIT systems has been demonstrated in several studies, indicating that EIT may be effective in the assessment of ventilation distribution in patients with asthma, COPD and cystic fibrosis. Furthermore, EIT has also compared well with lung measures such as lung volumes and lung density quantified by CT. However, there is currently little or no studies of the use of EIT in monitoring of patients with restrictive lung disease, in particular patients with spinal injuries.

Interventions

Electrical Impedance Tomography (EIT) is an emerging technique in the field of respiratory function testing which measures distribution of impedance of electrical currents across the chest. The distribution of impedance can be directly correlated to changes in ventilation distribution allowing for continuous monitoring. The project will be conducted in compliance with Good Clinical Practice and the applicable regulatory requirements. Subjects will be assessed either by the free or belt electr

Electrical Impedance Tomography (EIT) is an emerging technique in the field of respiratory function testing which measures distribution of impedance of electrical currents across the chest. The distribution of impedance can be directly correlated to changes in ventilation distribution allowing for continuous monitoring. The project will be conducted in compliance with Good Clinical Practice and the applicable regulatory requirements. Subjects will be assessed either by the free or belt electrodes in a single session. Precise positioning of free electrodes is expected to take approximately 30 minutes, while the custom-designed belt will be fitted within 5 minutes. The treating clinician / treating team will make the initial contact with potential participants regarding research. All patients admitted to Royal Perth ICU will be assessed using their admission diagnosis and medical history. Potential eligible participants are selected based on an inclusion and exclusion criteria. Subjects will take three deep inspirations to standardise volume history. After a 5 minute interval, breathing will be assessed for 1 minute during which the subject is asked to avoid taking a deep inspiration. This protocol will then be repeated with the subject sitting, supine and laid on left and right side. Each protocol will be performed in a randomised order and include the same volume history manoeuvre and 5 minute equilibration period before each 1 minute recording. A final two protocols will be performed in a seated position where the subject is asked to breath at normal lung volume for 1 minute, followed by a deep inspiration (or deep expiration), before returning to a normal lung volume for a further 1 minute of recording. Each study session is predicted to be completed within 2 hours. Participants will not need to complete any questionnaires but data regarding their clinical status including heart rate, blood pressure, oxygen requirements, ventilator settings (if applicable) will be collected during the EIT session, The EIT session will be administered by myself or other trial investigators.

Sponsors

University of Western Australia
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
19 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

patients with high spinal injuries (T8 and above), including patients that are mechanically ventilated and have lung pathology. All BMIs will be included.

Exclusion criteria

patients under the age of 18, patients who do not or cannot consent and patients where placement of electrodes (required for the use of EIT) is impossible.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026