MedTrace Logo

Non Invasive Mechanical Ventilation in Chronic Respiratory Insufficiency Patients During Rehabilitation

NCT01458314 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2015-11-13

No results posted yet for this study

Summary

Patients with Chronic Obstructive Pulmonary Disease (COPD) and chronic respiratory insufficiency (CRI) have severe dyspnoea during exercise at low load. Physiological studies performed in these patients during a unique session of training have shown a positive effect on exercise tolerance if non-invasive mechanical ventilation (NIV) was added during incremental effort test or endurance. Menadue and coworkers (2009) have shown in CRI patients with hypercapnia, secondary to COPD or cifoscoliosis, that combination of NIV during arm effort test improved ability to perform the exercise. Similar result was not reached using NIV during walking. Further studies have underlined a positive effect of the ventilation therapy during exercise within specific programs of pulmonary rehabilitation (Corner 2009). Moreover, the addition of NIV to an exercise training (ET) program in COPD patients may produce greater benefits in exercise tolerance and quality of life than exercise training alone (Garrod 2000).

A great improvement in health-related quality of life, functional status and gas exchange in COPD patients with chronic hypercapnic respiratory failure with nocturnal NIV compared with patients in pulmonary rehabilitation alone has been also shown by Duieverman (2008). However, in the same study Duieverman did not show any significant difference between groups in terms of tolerance to effort test.

Aim of the study is to evaluate if application of daily NIV during physical training may increase the benefits of rehabilitation in CRI patients with nocturnal NIV compared with patients with nocturnal NIV performing training under spontaneous breathing.

Conditions

  • Chronic Respiratory Insufficiency

Interventions

OTHER

Daily NIV during rehabilitation

Addition of non invasive mechanical ventilation (NIV) during daily rehabilitation in patients using nocturnal NIV

OTHER

Rehabilitation without NIV

Training in patients without NIV adoption

Sponsors & Collaborators

  • Azienda Ospedaliero, Universitaria Pisana

    collaborator OTHER

  • Ataturk Training and Research Hospital

    collaborator OTHER

  • Fondazione Salvatore Maugeri

    lead OTHER

Principal Investigators

  • Michele Vitacca, MD · Fondazione Salvatore Maugeri

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2015-06-30
Completion
2015-10-31

Countries

  • Italy

Study Locations

More Related Trials

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 NCT01458314 on ClinicalTrials.gov