Non-Invasive Mechanical Ventilation in Elderly Patients
NCT ID: NCT00600639
Last Updated: 2012-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
82 participants
INTERVENTIONAL
2004-01-31
2007-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
non-invasive ventilation with BiPAP Vision or another ICU ventilator with NIV option
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
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
2
standard therapy + oxygen
standard medical therapy that includes salbutamol, prednisolone and antibiotics as needed
oxygen plus medical therapy for ARF
Interventions
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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
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
standard medical therapy that includes salbutamol, prednisolone and antibiotics as needed
oxygen plus medical therapy for ARF
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hypercapnic acute respiratory failure (PaCO2 greater 50 mmHg and pH lower than 7.35)
* Respiratory rate (RR) higher 25 bpm after 12 hours of standard medical therapy.
Exclusion Criteria
* Kelly's score equal or higher than 4
* Cardio-respiratory arrest
* Systolic arterial blood pressure greater than 90 mmHg or severe arrhythmia
* Recent facial, oesophageal and gastric surgery
76 Years
ALL
No
Sponsors
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Villa Gaiato, Modena
UNKNOWN
Ospedale Regionale di Locarno
OTHER
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Principal Investigators
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Stefano Nava
Role: PRINCIPAL_INVESTIGATOR
Fondazione Salvatore Maugeri
Locations
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Istituto Scientifico di Pavia Fondazione Salvatore Maugeri
Pavia, Pavia, Italy
Countries
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Other Identifiers
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2004-78
Identifier Type: -
Identifier Source: secondary_id
FSM2004-78
Identifier Type: -
Identifier Source: org_study_id