Non-Invasive Mechanical Ventilation in Elderly Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Acute Respiratory Failure

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age higher 75 years old 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: Respiratory failure due to pulmonary oedema 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

Ages Eligible for Study
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Minimum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* 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<br>* Other names: BiPAP Vision or any other ICU ventilators with NIV option;Drug: standard medical therapy plus oxygen that includes salbutamol, prednisolone and antibiotics as needed<br>* Standard medical therapy includes drugs like beta2-agonists, steroids, anthicolinergic agents- antibuiotics as needed<br>|
| Active Comparator: 2<br>standard therapy + oxygen | Drug: standard medical therapy that includes salbutamol, prednisolone and antibiotics as needed<br>* oxygen plus medical therapy for ARF<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial Blood Gasses improvement Clinical improvement (decrease of respiratory rate and dyspnoea value) Length of Hospital stay |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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old patients, NIV, Intubation, COPD