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| Name | Class |
|---|---|
| University Hospital, Rouen | OTHER |
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The study aims to compare 2 different strategies used to setup non-invasive ventilation in patients with OCPD-OSA overlap.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full Polysomnography | Active Comparator | Patients will have NIV settings established using overnight full polysomnography. |
|
| Oximetry-capnography | Active Comparator | Patients will have NIV settings established using only Oximetry-capnography and subjective sleep comfort. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full polysomnography | Other | Full sleep and respiratory monitoring with EEG |
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| Measure | Description | Time Frame |
|---|---|---|
| PaCO2 (Arterial blood gas analysis) | Arterial blood gas analysis | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health related quality of life (CAT, SRI) | CAT, SRI | 3 months |
| Spirometry (FEV1, FVC) | FEV1, FVC | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29602814 | Derived | Patout M, Arbane G, Cuvelier A, Muir JF, Hart N, Murphy PB. Polysomnography versus limited respiratory monitoring and nurse-led titration to optimise non-invasive ventilation set-up: a pilot randomised clinical trial. Thorax. 2019 Jan;74(1):83-86. doi: 10.1136/thoraxjnl-2017-211067. Epub 2018 Mar 30. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Oximetry-capnography | Other | Limited monitoring with nurse observation and continuous oximetry-capnography overnight for NIV titration. |
|
|
| Subjective sleep comfort (VAS) | VAS | 3 months |
| Objective sleep comfort (Actigraphy) | Actigraphy | 3 months |
| Respiratory mechanics (to include, work of breathing, PEEPdyn, Cdyn, EMGdi, EMGpara) | Invasive respiratory mechanics performed on discharge NIV settings to include, work of breathing, PEEPdyn, Cdyn, EMGdi, EMGpara | Day 1 |
| NIV compliance (machine recorded) | NIV machine recorded compliance | 3 months |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |