Diaphragm Training Post-Cardiac Surgery

Diaphragmatic Paralysis Clinical Trial

— DIATRACS  

Official title:

Randomized Controlled Trial on the Diaphragm Training With Threshold for Patient With Post-Cardiac Surgery Diaphragmatic Paralysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00597298
• Other study ID #: SCPN-01-08
• Secondary ID: PN 001-08
• Status: Completed
• Phase: N/A
• First received: January 9, 2008
• Last updated: February 3, 2009
• Start date: January 2008
• Est. completion date: January 2009

Study information

• Verified date: February 2009
• Source: Ospedali Riuniti Trieste
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• heart failure

• COPD

• neuromuscular disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Diaphragmatic Paralysis
• Paralysis
• Respiratory Paralysis

Intervention

Device:
• Threshold
Inspiratory muscle training program using a variable pressure device. An inspiratory muscle training device comprises a chamber having an opening for the passage of air to be inhaled and exhaled, and an inlet permitting air to be inhaled to enter the chamber and to pass to the opening. A one-way exhaust valve permits exhaled air entering through the opening to escape from the chamber, and another valve is provided to resist the entry of air to be inhaled into the chamber, the latter valve serving to vary the degree of resistance in dependence upon the volume of air that has passed through the inlet.
• sham threshold
non-training physical activity

Locations

Country	Name	City	State
Italy	Fisiopatologia Respiratoria	Trieste	TS

Sponsors (1)

Lead Sponsor	Collaborator
Ospedali Riuniti Trieste

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Versteegh MI, Braun J, Voigt PG, Bosman DB, Stolk J, Rabe KF, Dion RA. Diaphragm plication in adult patients with diaphragm paralysis leads to long-term improvement of pulmonary function and level of dyspnea. Eur J Cardiothorac Surg. 2007 Sep;32(3):449-56. Epub 2007 Jul 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	chest x-ray mobility of the diaphragm		6 and 12 months	No
Secondary	Maximal inspiratory pressure (MIP), cm H2O		6 and 12 months	No