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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-78 |
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| Name | Class |
|---|---|
| Villa Gaiato, Modena | UNKNOWN |
| Ospedale Regionale di Locarno | OTHER |
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The efficacy of NIMV to treat HARF has been widely demonstrated. However, in most of the studies performed in ICUs and in another facilities the mean age of the patients is usually less than 70 years.
A multicentric, randomized-controlled trial conduced in a group of "ELDERLY" patients with the mean age higher than 76 years, to compare the use of NIMV with Standard Medical Treatment (SMT) in the treatment of an episode of Acute Hypercapnic Respiratory Failure.
Non-invasive mechanical ventilation (NIMV) has been successfully used in Hypercapnic Acute Respiratory Failure (HARF) since endotracheal intubation (ETI) and invasive ventilation are associated to high morbidity and mortality rate.
because of the lack of beds in most Intensive Care Units (ICUs) and the high mortality and cost associated with the increased of age, the "Elderly" patients affected by ARF due to chronic diseases are not always considered for ETI.
The efficacy of NIMV to treat HARF has been widely demonstrated. However, in most of the studies performed in ICUs and in another facilities the mean age of the patients is usually less than 70 years (see tab1).
Authors MEAN AGE
(yrs) TYPE of STUDY
Bott <80 COPD NIV vs Medical Therapy
Brochard71±9 COPD NIV vs Medical Therapy
Kramer 66±7 COPD NIV vs Medical Therapy
Andeev 63±4 COPD NIV vs Medical Therapy
Barbe 70±2 COPD NIV vs Medical Therapy
Bardi 68±8 COPD NIV vs Medical Therapy
Plant 69±8 COPD NIV vs Medical Therapy
Thys 71±8 COPD NIV vs sham NIV
Nava 68±8 COPD NIV in weaning
Girault 63±14 NIV in weaning
Ferrer 70±7 NIV in weaning
Hill 71±3 COPD PAV vs PSV
Confalonieri 66±14 PNEUMONIA NIV vs Medical Therapy
Martin 64±17 Miscellaneous NIV vs Medical Therapy
Conti 72±7 COPD NIV vs EI
A multicentric, randomized-controlled trial conducted in a group of "ELDERLY" patients with the mean age higher than 76 years, to compare the use of NIMV with Standard Medical Treatment (SMT) in the treatment of an episode of Acute Hypercapnic Respiratory Failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | non-invasive ventilation with BiPAP Vision or another ICU ventilator with NIV option |
|
| 2 | Active Comparator | standard therapy + oxygen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive mechanical ventilation using a BiPAP Vision or any other ICU ventilators with NIV option | Device | A mode of ventilation that does not require the insertion of the endotracheal tube, since the support is delivered throgh a full face or nasal mask |
| Measure | Description | Time Frame |
|---|---|---|
| Meet the criteria for INTUBATION: pH < 7.2 or pH < 7.25 in two consecutive occasions or worsening pH during NIV or rapid increase of 20mmHg of PaCO2 from baseline or PaO2< 50mmHg with FiO2 40% or Kelly score > 4 Mortality rate | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial Blood Gasses improvement Clinical improvement (decrease of respiratory rate and dyspnoea value) Length of Hospital stay | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefano Nava | Fondazione Salvatore Maugeri | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Scientifico di Pavia Fondazione Salvatore Maugeri | Pavia | Pavia | 27100 | Italy |
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|
| standard medical therapy plus oxygen that includes salbutamol, prednisolone and antibiotics as needed | Drug | Standard medical therapy includes drugs like beta2-agonists, steroids, anthicolinergic agents- antibuiotics as needed |
|
| standard medical therapy that includes salbutamol, prednisolone and antibiotics as needed | Drug | oxygen plus medical therapy for ARF |
|
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D000900 | Anti-Bacterial Agents |
| D006301 | Health Services Needs and Demand |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D006302 | Health Services Research |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D003695 | Delivery of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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