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| Name | Class |
|---|---|
| University of Padova | OTHER |
| King's College London | OTHER |
| Lane Fox Respiratory | OTHER |
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To assess patients with hypercapnic respiratory failure using echocardiography,cardiac output measurements and markers of neural respiratory drive (EMGpara) prior to, during and after non-invasive ventilation (NIV) initiation, and to follow the patients for 3 months. The investigators hypothesize that the improvement in cardiac function and/or respiratory mechanics over time are associated with ongoing improvements in oxygenation, quality of life and exercise capacity.
Respiratory failure is characterized by the incapacity of the respiratory system to maintain the normal arterial blood gas homeostasis. Specifically, the overlap of hypoxaemia and hypercapnia (PaCO2 >6 kPa) is referred to as Hypercapnic Respiratory Failure (HRF). HRF is one of the most common causes for hospital admission with high re-admission rates, therefore constitute a major burden on healthcare systems. Non Invasive Ventilation (NIV) is a well established treatment in patients with hypercapnic respiratory failure who frequently suffer with associated pulmonary hypertension (PH). NIV helps to increase arterial oxygenation and reduces hypercapnia. It is used in patients with hypercapnic respiratory failure caused by Obesity Hypoventilation Syndrome (OHS). The associated degree of PH can lead to an increased afterload of the right ventricle (RV) that causes progressive remodelling of the right heart. RV dysfunction is correlated with a reduced long term prognosis in respiratory conditions. In literature NIV is shown as effective method to treat acute hypercapnic respiratory failure in OHS.
It has not been described how NIV impacts on cardiac function and NRD in OHS.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parasternal EMG (EMGpara) and Transthoracic Echocardiography | Other | OHS patients recruited will have EMGpara and Transthoracic Echocardiography at admission and when established on NIV at 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Patients commencing on Non Invasive Ventilation (NIV); change in Cardiac Function from baseline and at 3 months | Patients with hypercapnic respiratory failure caused by obesity hypoventilation syndrome commencing on NIV; change in cardiac function using echocardiography at baseline and 3 months. Measurements taken prior to NIV initiation, and follow up at 3 months. | 3 months |
| Patients commencing on Non Invasive Ventilation (NIV); change on Nueral Respiratory Drive (NRD) from baseline and at 3 months | Patients with hypercapnic respiratory failure caused by obesity hypoventilation syndrome commencing on NIV; change in markers of nerual respiratory drive/EMG para. Measurements taken prior to, and after NIV initiation, and follow up at 3 months. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patients commencing on Non Invasive Ventilation (NIV); change in Oxygenation from baseline, 6 weeks post initiation and at 3 months | To demonstrate that the improvement in cardiac function and/or respiratory mechanics over time are associated with ongoing improvements in oxygenation by taking samples of arterial blood gases. Measurements are made prior to, during and after NIV initiation, and follow up at 3 months. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients presenting with a confirmed diagnosis of OHS and Overlap Syndrome and hypercapnic respiratory failure with the clinical intervention to commence on NIV will be invited to participate in the trial.
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| Name | Affiliation | Role |
|---|---|---|
| Joerg Dr Steier | Guy's and St Thomas' NHS Foundation Trust | Principal Investigator |
| Marino Dr Phil | Guy's and St Thomas' NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guys and St Thomas NHS Foundation | London | SE1 7EH | United Kingdom |
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| Label | URL |
|---|---|
| JTD publication | View source |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| 3 months |
| Patients commencing on Non Invasive Ventilation (NIV); change in Quality of Life from baseline, 6 weeks post initiation and at 3 months | To demonstrate the hypothesis that the improvement in cardiac function and/or respiratory mechanics over time are associated with ongoing improvements in quality of life by asking participants to complete the Medical Research Council (MRC) dyspnoea scale. Measurement will be taken prior to NIV initiation, 6 weeks post initiation and at follow up at 3 months. | 3 months |
| Patients commencing on Non Invasive Ventilation (NIV); change in Quality of Life from baseline, 6 weeks post initiation and at 3 months | To demonstrate the hypothesis that the improvement in cardiac function and/or respiratory mechanics over time are associated with ongoing improvements in quality of life by asking participants to complete the modified BORG Scale (breathlessness). Measurement will be taken prior to NIV initiation, 6 weeks post initiation and at follow up at 3 months. | 3 months |
| Patients commencing on Non Invasive Ventilation (NIV); change in Quality of Life from baseline, 6 weeks post initiation and at 3 months | To demonstrate the hypothesis that the improvement in cardiac function and/or respiratory mechanics over time are associated with ongoing improvements in quality of life by asking participants to complete the St George's Respiratory Questionnaire (SGRQ). Measurement will be taken prior to NIV initiation, 6 weeks post initiation and at follow up at 3 months. | 3 months |
| Patients commencing on Non Invasive Ventilation (NIV); change in Quality of Life from baseline, 6 weeks post initiation and at 3 months | To demonstrate the hypothesis that the improvement in cardiac function and/or respiratory mechanics over time are associated with ongoing improvements in quality of life by asking participants to complete the Hospital Anxiety and Depression Scale (HADS). Measurement will be taken prior to NIV initiation, 6 weeks post initiation and at follow up at 3 months. | 3 months |
| Patients commencing on Non Invasive Ventilation (NIV); change in Quality of Life from baseline, 6 weeks post initiation and at 3 months | To demonstrate the hypothesis that the improvement in cardiac function and/or respiratory mechanics over time are associated with ongoing improvements in quality of life by asking participants to complete the Epworth Sleepiness Scale (ESS). Measurement will be taken prior to NIV initiation, 6 weeks post initiation and at follow up at 3 months. | 3 months |
| Patients commencing on Non Invasive Ventilation (NIV); change in Exercise Capacity. | To demonstrate that the improvement in cardiac function and/or respiratory mechanics over time are associated with ongoing improvements in oxygenation by participants performing the Gate speed of 4 metres test prior to,during and after NIV initiation and at 6 weeks post initiation, and follow up at 3 months. | 3 months |