Non Invasive Mechanical Ventilation in Chronic Respiratory Insufficiency Patients During Rehabilitation

INTERVENTION

Group 1 (NIV during training + nocturnal NIV): This group of patients will use the usual NIV during night and will perform a rehabilitative program of at least 20 sessions of training at cycloergometer under NIV.

NO INTERVENTION

Group 2 (training in Spontaneous Breathing [SB] + nocturnal NIV): This group of patients will use the usual NIV during night and will be trained in a rehabilitative daily program without NIV. This group will be considered the "control" group.

Sessions: 30 minutes/session, 2 times/day, 4-5 times a week for a total of 20-25 session in 3 weeks.

Intensity: each patient will start at 50% of each individual's maximum work capacity (cycloergometer) increasing up to the maximum tolerated, according to Maltais's protocol.

NIV SETTING:

Training: Facial mask with usual setting (Inspiratory Positive Airway Pressure [IPAP] 10-15; Expiratory Positive Airway Pressure [EPAP] 4-6 cmH20) with a possible adjustment in agreement with the comfort.

The adjustment of ventilation during training will be only within the first 3 sessions according to the following protocol:

COPD patients: increase up to 3 cmH2Os of EPAP and decrease up to 3 cmH2Os of IPAP.

Restricted patients: increase up to 3 cmH2Os of IPAP.

Nocturnal ventilation: mask and usual setting

The primary outcome of the study is evaluation of effort tolerance measured by 6 minutes Walking Test (6-min Walking Test). The hypothesis is to verify a percentage of variation between the two groups equal to 10% after the rehabilitative program. To get a study power of 80% and an alpha error <5% 25 patients for group had to be enrolled.

Inclusion criteria

• A total of 50 patients aging 40-79 years will be enrolled ( 8 out of 50 will be from FSM in Lumezzane)
• Patients with chronic respiratory insufficiency (CRI) in treatment with nocturnal NIV from at least six months;
• Clinical stability (absence of disease re-exacerbations from at least 4 weeks before the study).

Exclusion criteria

• Cardiac diseases: unstable and/or exercise angina, congestive heart failure cardiac, uncontrolled cardiac arrhythmias, sinus tachycardia at rest (HR >120 bpm), hypertension at rest and/or during effort not adequately checked by therapy
• Orthopaedic and/or neuromuscular illnesses.