Non-Invasive Mechanical Ventilation in Elderly Patients

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status and phase: Terminated; Phase 4

Conditions: Acute Respiratory Failure

Treatments: Drug: standard medical therapy plus oxygen that includes salbutamol, prednisolone and antibiotics as needed; Device: Non-invasive mechanical ventilation using a BiPAP Vision or any other ICU ventilators with NIV option; Drug: standard medical therapy that includes salbutamol, prednisolone and antibiotics as needed

Study type: Interventional

Funder types: Other

Identifiers

NCT00600639

FSM2004-78

2004-78

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 76+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

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

2

Active Comparator group

Description:

standard therapy + oxygen

Treatment:

Drug: standard medical therapy that includes salbutamol, prednisolone and antibiotics as needed