PSG Versus Oxim-capnography to Setup Home NIV

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-03-31

Brief Summary

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The study aims to compare 2 different strategies used to setup non-invasive ventilation in patients with OCPD-OSA overlap.

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Detailed Description

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With limited comparative data to support the different strategies, there is substantial variation across Europe and the United States in the methods used by clinicians to set up home non-invasive ventilation (NIV) for patients with chronic respiratory failure as a consequence of sleep disordered breathing. Indeed with few data to support the practice, many centres employ full montage polysomnography, which is not only a significant physical burden to the patient but also a financial burden to the healthcare provider in terms of the facilities required, staff training and equipment.

The investigators propose to undertake a randomised controlled trial to compare the clinical effectiveness, in terms of the change in daytime arterial partial pressure of carbon dioxide (PaCO2) at 3 months, of limited respiratory polygraphy and full polysomnography to set up NIV in patients with COPD-OSA overlap. Secondary outcome measures at 3 months will include overnight control of gas exchange, subjective sleep quality, health related quality of life and ventilator adherence. COPD-OSA overlap are a patient group that have a rising prevalence with limited data currently available detailing NIV set up, which wholly supports the rationale of using this increasingly important group as a target population for this trial.

Conditions

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COPD OSA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Full Polysomnography

Patients will have NIV settings established using overnight full polysomnography.

Group Type ACTIVE_COMPARATOR

Full polysomnography

Intervention Type OTHER

Full sleep and respiratory monitoring with EEG

Oximetry-capnography

Patients will have NIV settings established using only Oximetry-capnography and subjective sleep comfort.

Group Type ACTIVE_COMPARATOR

Oximetry-capnography

Intervention Type OTHER

Limited monitoring with nurse observation and continuous oximetry-capnography overnight for NIV titration.

Interventions

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Full polysomnography

Full sleep and respiratory monitoring with EEG

Intervention Type OTHER

Oximetry-capnography

Limited monitoring with nurse observation and continuous oximetry-capnography overnight for NIV titration.

Intervention Type OTHER

Other Intervention Names

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Polysomnography Limited respiratory monitoring

Eligibility Criteria

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Inclusion Criteria

* COPD (as defined by GOLD criteria\[4\])
* OSA (ODI \> 7.5 events/hr, AHI \> 5events/hr)
* PaCO2 \> 6 kPa
* BMI \> 30 kg/m2

Exclusion Criteria

* Decompensated respiratory failure (pH \< 7.35)
* Inability to tolerate NIV (\< 4 hours usage at in hospital titration)
* Contraindication to NIV
* Pregnancy
* Aged \<18
* Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No