Diaphragm Training Post-Cardiac Surgery (DIATRACS)

Ospedali Riuniti Trieste

Status: Completed

Conditions: Diaphragmatic Paralysis

Treatments: Device: sham threshold; Device: Threshold

Study type: Interventional

Funder types: Other

Identifiers

NCT00597298

SCPN-01-08

PN 001-08

Details and patient eligibility

About

Diaphragm paralysis is a possible complication of cardiac surgery. The spontaneous recovery of the diaphragm mobility is slow and partial or absent in most cases. We hypothesize that a program of diaphragm muscle training by means of the Threshold variable resistance device could improve the rate of complete diaphragm mobility recovery in a shorter time period. Patient with post-cardiosurgical diaphragm paralysis will be random assigned to the specific training protocol or to a generic non-training physical activity.

Full description

Inclusion criteria: All consecutive patients aged from 18 to 80 years old with RX-defined diaphragm paralysis post a major cardiosurgery intervention such as coronary bypass, valve substitution or both.

Exclusion criteria: Acute cardiac failure, COPD, chronic respiratory failure with indication to home oxygen therapy, neuromuscular diseases.

Outcome measures: MIP, MEP, diaphragm function recovery assessed by chest X-ray, lung function tests.

Enrollment: 48 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• post-cardiosurgical diaphragmatic paralysis recent cardiosurgical intervention for by-pass and/or valve replacement

Exclusion criteria

• heart failure
• COPD
• neuromuscular disease

Trial design

48 participants in 2 patient groups

1

Active Comparator group

Description:

inspiratory muscle training program using a pressure threshold device

Treatment:

Device: Threshold

2

Sham Comparator group

Treatment:

Device: sham threshold