Overview

Non-Invasive Mechanical Ventilation in Elderly Patients

Status:
Terminated
Trial end date:
2007-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators:
Ospedale Regionale di Locarno
Villa Gaiato, Modena
Treatments:
Albuterol
Anti-Bacterial Agents
Antibiotics, Antitubercular
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
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