NCT02828007

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 28, 2016

Status Verified

July 1, 2016

Enrollment Period

6 months

First QC Date

February 12, 2016

Last Update Submit

November 24, 2016

Conditions

Healthy Participants

Keywords

EITNIV

Outcome Measures

Primary Outcomes (1)

  • Characteristics seen during ventilation in different modes of ventilation

    1 day

Secondary Outcomes (5)

  • Correlation between tidal volume assessed by EIT

    1 day

  • Correlation between tidal volume assessed by NIV software

    1 day

  • Detection of patient ventilator asynchrony using physiological measurements

    1 day

  • Measurements of Neural Respiratory Drive using parasternal EMG

    1 day

  • Patient Comfort using Visual Analogue Scale

    1 day

Study Arms (1)

Treatment/Intervention

EXPERIMENTAL

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.

Device: NIV Group

Interventions

NIV GroupDEVICE

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.

Treatment/Intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Absence of any underlying lung disease
  • FEV1/FVC \> 70%

You may not qualify if:

  • Pregnancy
  • Aged \<18, \>80
  • Significant physical or psychiatric comorbidity
  • that would prevent compliance with trial protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guys and St Thomas NHS Foundation

London, SE1 7EH, United Kingdom

Location

Study Officials

  • Nicholas Hart

    GSTT

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2016

First Posted

July 11, 2016

Study Start

April 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 28, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)