NCT02765360

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). NIV consists of a machine (ventilator) that is blowing air inside a patient's airway through a mask. NIV provides patients with a bigger breath. Bigger breaths help patients to have a more oxygen and less waste gas (or carbon dioxide) in their body. These changes can improve outcomes 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 flow of air through the mask
  • Pressure support ventilation (PSV) which delivers a constant flow of air through the mask and, on top of that, delivers more flow when the patient begins to inhale
  • Volume targeted ventilation which delivers a flow of air through the mask that is adjusted breath by breath in order to achieve a preset volume. These different type of blowing have consequences on patient comfort as well as on the improvement of their ventilation. To assess the improvement of the ventilation, currently blood tests are used, 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 on 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 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
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

12 months

First QC Date

February 12, 2016

Last Update Submit

May 2, 2017

Conditions

OHSCOPD

Keywords

EITNIV

Outcome Measures

Primary Outcomes (1)

  • Characteristics seen during ventilation in different modes of ventilation

    What happens to the lung when ventilation on different modes

    1 day

Secondary Outcomes (5)

  • Lung volumes on EIT compared with pneumotachography assessed lung volumes

    1 day

  • Patient ventilator asynchrony

    1 day

  • Neural respiratory drive (EMGpara)

    1 day

  • Subjective patient comfort (Visual analogue scale - VAS - Borg scale)

    1 day

  • Patient comfort and lung homogeneity

    1 day

Study Arms (1)

Treatment

EXPERIMENTAL

Each patient will be assigned to Continuous Positive Airway Pressure (CPAP), Pressure Support Ventilation (PSV) and Pressure Control Ventilation (PCV) modes in a random order with a 10 minute washout period modes.

Other: Treatment Group

Interventions

Treatment GroupOTHER

Participants will be established on the randomised mode of ventilation and will have continuous assessment of the following during the assessment period: * Electrical impedance tomography * EMGpara * SpO2 * tcCO2 * Pneumotachography * End-tidal CO2 monitoring

Treatment

Eligibility Criteria

Age18 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • On domiciliary NIV for at least 3 months
  • Domiciliary NIV set up following an arterial puncture showing a PaCO2 \> 6 kPa
  • Compliance of \> 4 hours per night
  • FEV1 / FVC \< 70% and FEV1 \< 70% for COPD participants
  • FEV1 \> 70% for OHS participants
  • Previous chest computed tomography for COPD participants
  • BMI \>35 kg/m2 for OHS participants

You may not qualify if:

  • Pregnancy
  • Aged \<18, \>80
  • Significant physical or psychiatric comorbidity that would prevent compliance with trial protocol
  • Decompensated respiratory failure (pH \< 7.35)
  • BMI \> 50kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guys and St Thomas NHS Trust

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nick Hart

    Guy's and St Thomas' NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
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

May 6, 2016

Study Start

May 1, 2016

Primary Completion

April 30, 2017

Study Completion

April 30, 2017

Last Updated

May 3, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)