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
Overview
- Phase
- Phase 4
- Intervention
- Non-invasive mechanical ventilation using a BiPAP Vision or any other ICU ventilators with NIV option
- Conditions
- Acute Respiratory Failure
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
1
non-invasive ventilation with BiPAP Vision or another ICU ventilator with NIV option
Intervention: Non-invasive mechanical ventilation using a BiPAP Vision or any other ICU ventilators with NIV option
1
non-invasive ventilation with BiPAP Vision or another ICU ventilator with NIV option
Intervention: standard medical therapy plus oxygen that includes salbutamol, prednisolone and antibiotics as needed
2
standard therapy + oxygen
Intervention: standard medical therapy that includes salbutamol, prednisolone and antibiotics as needed
Outcomes
Primary Outcomes
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
Time Frame: 3 months
Secondary Outcomes
- Arterial Blood Gasses improvement Clinical improvement (decrease of respiratory rate and dyspnoea value) Length of Hospital stay(3 months)