Non Invasive Mechanical Ventilation Versus Respiratory Rehabilitation in Hypercapnic COPD

Summary

Objective: To analyze the additional benefits of exercise training application by the non-invasive home mechanical ventilation in patients with stable COPD and hypercapnic respiratory failure. SUBJECT: moderate-severe COPD (FEV1 \<60%) in chronic respiratory failure (hypoxemia and hypercapnia PaCO2\> 45mmHg). GROUPS: 45 patients included prospectively and randomly into 3 groups of 15: a) training + NIPPV group, b) Group training, c) Group NIPPV. Hypothesis: A training program to the effort associated with treatment with NIPPV significantly increase the effects compared with each treatment. MAIN OBJETIVE: Effects on exercise capacity as measured by the test of endurance cycling and test 6-minute walk (distance). SECONDARY OBJECTIVES: Impact on quality of life and dyspnea, as measured by questionnaire and CRQ, systemic inflammatory response (CRP, IL-8, TNF-α), changes in peripheral muscle strength (1RM test, isometric) and effects score BODE index.

Conditions

• Lung, Hyperlucent
• Positive-Pressure Respiration, Intrinsic

Interventions

PROCEDURE

ventilation

positive-pressure breathing bilevel (BiPAP ® Respironics, Inc.) Parameters initially programmed be: IPAP 10 cm H2O, EPAP 4 cmH2O, method ST setting yourself respirations 12 breaths minute. The IPAP was progressively increased to a maximum of 20 cm H2O, depending on patient tolerability, clinical response and arterial oxygen saturation was continuously monitored by pulse oximetry, trying to avoid possible leaks through the mask. It can also supply oxygen through a cannula connected to the mask at a flow rate of 2-4 liters per minute to maintain oxygen saturation at around 85-90%. Patients aired uninterruptedly during nighttime (minimal between 6-8 hours night).

PROCEDURE

excecise training

The training program (trained group) was carried out for 12 weeks and sessions of 40 minutes duration: * 20 minutes of bicycle ergometer with an initial charge of about 70% of initial maximal oxygen consumption, increasing the load every two weeks as tolerated. * Weightlifting in 2 sets of 6 replicates of 5 simple exercises. These are held at a station multigimnástica (CLASSIC Fitness Center, KETTLER)

PROCEDURE

Both

both types of intervention

Sponsors & Collaborators

• Fondo de Investigacion Sanitaria

  collaborator OTHER

• Hospitales Universitarios Virgen del Rocío

  lead OTHER

Principal Investigators

• Eduardo Marquez, MD · Hospital Universitario Virgen del Rocio

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

40 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-03-31

Primary Completion

2011-05-31

Completion

2011-05-31