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Non-Invasive Mechanical Ventilation in Elderly Patients

NCT00600639 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2012-07-17

No results posted yet for this study

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.

Conditions

  • Acute Respiratory Failure

Interventions

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

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

Sponsors & Collaborators

  • Villa Gaiato, Modena

    collaborator UNKNOWN

  • Ospedale Regionale di Locarno

    collaborator OTHER

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Stefano Nava · Fondazione Salvatore Maugeri

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
76 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00600639 on ClinicalTrials.gov