Non-Invasive Mechanical Ventilation in Elderly Patients

NCT00600639 | Terminated Phase 4 DMC

• 2 other identifiers: FSM2004-782004-78
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure

Keywords

old patients; NIV; Intubation; COPD

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Secondary Outcomes (1)

• Arterial Blood Gasses improvement Clinical improvement (decrease of respiratory rate and dyspnoea value) Length of Hospital stay

  3 months

Study Arms (2)

1

EXPERIMENTAL

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

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

standard therapy + oxygen

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

Interventions

Non-invasive mechanical ventilation using a BiPAP Vision or any other ICU ventilators with NIV option DEVICE

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

Also known as: BiPAP Vision or any other ICU ventilators with NIV option

1

standard medical therapy plus oxygen that includes salbutamol, prednisolone and antibiotics as needed DRUG

Standard medical therapy includes drugs like beta2-agonists, steroids, anthicolinergic agents- antibuiotics as needed

1

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

oxygen plus medical therapy for ARF

2

Eligibility Criteria

• Age: 76 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• Villa Gaiato, Modena: collaborator
• Ospedale Regionale di Locarno: collaborator

Study Sites (1)

Istituto Scientifico di Pavia Fondazione Salvatore Maugeri

Pavia, Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Prednisolone; Anti-Bacterial Agents; Health Services Needs and Demand

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Health Services Research; Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Stefano Nava

  Fondazione Salvatore Maugeri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 14, 2008
• First Posted: January 25, 2008
• Study Start: January 1, 2004
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: July 17, 2012

Record last verified: 2008-01

Locations

IT (1)