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| Sponsor: | Fondazione Salvatore Maugeri |
|---|---|
| Collaborators: |
Villa Gaiato, Modena Ospedale Regionale di Locarno |
| Information provided by: | Fondazione Salvatore Maugeri |
| ClinicalTrials.gov Identifier: | NCT00600639 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Respiratory Failure in Older Patients |
Device: Non-invasive mechanical ventilation using a BiPAP Vision or any other ICU ventilators with NIV option Drug: standard medical therapy plus oxygen that includes salbutamol, prednisolone and antibiotics as needed Drug: standard medical therapy that includes salbutamol, prednisolone and antibiotics as needed |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Non-Invasive Mechanical Ventilation in Elderly Patients Affected by Acute Hypercapnic Respiratory Failure:A Randomized Control Study vs Standard Medical Therapy A Multicentric Randomized Controlled Trial |
| Enrollment: | 82 |
| Study Start Date: | January 2004 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
non-invasive ventilation with BiPAP Vision or another ICU ventilator with NIV option
|
Device: Non-invasive mechanical ventilation using a BiPAP Vision or any other ICU ventilators with NIV option
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
Other Name: BiPAP Vision or any other ICU ventilators with NIV option
Drug: standard medical therapy plus oxygen that includes salbutamol, prednisolone and antibiotics as needed
Standard medical therapy includes drugs like beta2-agonists, steroids, anthicolinergic agents- antibuiotics as needed
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|
Active Comparator: 2
standard therapy + oxygen
|
Drug: standard medical therapy that includes salbutamol, prednisolone and antibiotics as needed
oxygen plus medical therapy for ARF
|
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.
Eligibility| Ages Eligible for Study: | 76 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Italy | |
| Istituto Scientifico di Pavia Fondazione Salvatore Maugeri | |
| Pavia, Italy, 27100 | |
| Principal Investigator: | Stefano Nava | Fondazione Salvatore Maugeri |
More Information
| Responsible Party: | Fondazione S.Maugeri |
| ClinicalTrials.gov Identifier: | NCT00600639 History of Changes |
| Other Study ID Numbers: | FSM2004-78, 2004-78 |
| Study First Received: | January 14, 2008 |
| Last Updated: | January 24, 2008 |
| Health Authority: | Italy: Ethics Committee |
|
old patients NIV Intubation COPD |
|
Respiratory Distress Syndrome, Adult Respiratory Insufficiency Hypoventilation Lung Diseases Respiratory Tract Diseases Respiration Disorders Signs and Symptoms, Respiratory Signs and Symptoms Albuterol Methylprednisolone Anti-Bacterial Agents Methylprednisolone acetate Prednisolone acetate Prednisolone Methylprednisolone Hemisuccinate |
Prednisolone phosphate Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents |
