Trial | NCT00600639  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    prednisone albuterol ...

  • Study Participants

    82
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.
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.
Study Started
Jan 31
2004
Primary Completion
Dec 31
2007
Study Completion
Dec 31
2007
Last Update
Jul 17
2012
Estimate

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 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

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

1 Experimental

non-invasive ventilation with BiPAP Vision or another ICU ventilator with NIV option

2 Active Comparator

standard therapy + oxygen

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
No Results Posted