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There is evidence that noninvasive mechanical ventilation (NIV) is effective in the treatment of severe exacerbations of COPD presenting respiratory acidosis.
The aim of the study is to evaluate the benefit of adding NIV to conventional treatment in patients with COPD exacerbation and hypercapnic respiratory failure without acidosis requiring hospital admission. It is known that NIV improves respiratory mechanics, so the primary outcome will be respiratory muscle function.
All patients admitted to the hospital for COPD exacerbation and hypercapnic respiratory failure without acidosis will be included for a period of 12 months. The patients will be randomized into two groups (conventional treatment or conventional treatment plus NIV). Clinical data, blood gases, muscle strength parameters will be collected at the inclusion time and 24h after starting NIV. Quality of life and hospital stay will be measured at discharge. All patients will be followed for a year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard treatment | No Intervention | Standard treatment consists in bronchodilator and parenteral corticosteroids and oxygen therapy. | |
| Standard treatment plus non-invasive ventilation | Experimental | This arm consists in bronchodilator and parenteral corticosteroids and oxygen therapy plus non-invasive ventilation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive ventilation | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory muscle function. | Measurement of maximal inspiratory pressure and sniff nasal inspiratory pressure using a portable respiratory pressure meter. | At baseline, at discharge (average of 8 days), 6 months and one year later. |
| Measure | Description | Time Frame |
|---|---|---|
| Days of hospitalization. | At discharge (average of 8 days). | |
| Dyspnea scale questionnaire | At baseline, at discharge, 6 months and one year later. | |
| Quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cristina Estirado, PhD | Contact | 932483138 | 97623@parcdesalutmar.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Mar (Servei de PneumologÃa) | Barcelona | Barcelona | 08003 | Spain |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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| At baseline, 6 months and one year later. |
| Blood gases | At baseline and at discharge (average of 8 days). |
| Number of hospital readmissions in the next year | At one year after discharge (average of 8 days). |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |