NCT00600639

Non-Invasive Mechanical Ventilation in Elderly Patients

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 76 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Respiratory Failure

Interventions

Type	Name	Description
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
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
DRUG	standard medical therapy that includes salbutamol, prednisolone and antibiotics as needed	oxygen plus medical therapy for ARF

Timeline

• Start date: 2004-01-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2008-01-25
• Last updated: 2012-07-17

Locations

1 site across 1 country: Italy