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EIT Study With Healthy Patients

NCT02828007 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-11-28

No results posted yet for this study

Summary

Patients with severe respiratory diseases such as chronic obstructive pulmonary disease (COPD) or obesity-hypoventilation syndrome (OHS) can benefit from having non-invasive ventilation (NIV). Non-invasive ventilation consists of a machine (ventilator) that is blowing air through a mask. NIV provides patients with a bigger expansion of their lung when they are breathing. This better expansion helps patients to have more oxygen and less waste gas (or carbon dioxide) in their body.

These improvements enhance survival and quality of life. In order to provide appropriate ventilation for each patient, the ventilator can generate different types of blowing:

* Continuous positive airway pressure (CPAP) which delivers a constant pressure to the mask
* Pressure support ventilation (PSV) which delivers a constant pressure to the mask and, on top of that, delivers more pressure when the patient begins to breathe in.
* Pressure control ventilation (PCV), which is similar to PSV, but use a fixed time to generate the flow when the patient begins to breathe in.

These different types of blowing have consequences on patient comfort as well as on the improvement of their ventilation.

To assess the improvement of the ventilation, the investigators currently use blood tests, however, these reflect overall output and may miss more subtle changes in breathing that could affect how patients feel.

Electrical impedance tomography (EIT) is a new technology that involves wearing a belt of sensors around the chest that provides information on how well the lungs are being filled with air by the ventilator. It allows a non-invasive assessment of the effect of NIV onto lung ventilation in real-time.

The investigators hope to use the EIT technology to assess in real-time patients lung ventilation when they are using the NIV. The investigators hope that EIT will provide them with information on which type of blowing is more effective and more comfortable than the others.

Conditions

  • Healthy Participants

Interventions

DEVICE

NIV Group

Each patient will be using Non Invasive Ventilation (NIV) and will use it on each possible ventilation mode in a random order with a 10 minutes washout period between modes.

Sponsors & Collaborators

  • B&D Electromedical

    collaborator INDUSTRY

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Nicholas Hart · GSTT

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • United Kingdom

Study Locations

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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 NCT02828007 on ClinicalTrials.gov