Diaphragm Training Post-Cardiac Surgery

NCT ID: NCT00597298

Last Updated: 2009-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-01-31

Brief 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.

Detailed 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.

Conditions

Diaphragmatic Paralysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: SINGLE

Study Groups

1

inspiratory muscle training program using a pressure threshold device

Group Type: ACTIVE_COMPARATOR

Threshold

Intervention Type: DEVICE

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.

2

Group Type: SHAM_COMPARATOR

sham threshold

Intervention Type: DEVICE

non-training physical activity

Interventions

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.

Intervention Type: DEVICE

sham threshold

non-training physical activity

Intervention Type: DEVICE

Other Intervention Names

Threshold IMT, Respironics,Cedar Grove NJ, USA; HS730EU-010

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• heart failure
• COPD
• neuromuscular disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedali Riuniti Trieste

OTHER

Sponsor Role: lead

Responsible Party

SC Pneumologia - Ospedali RIuniti di Trieste

Principal Investigators

Maja Demsar, MD

Role: STUDY_DIRECTOR

AOUTS

Marco Confaloniei, MD

Role: STUDY_CHAIR

AOUTS

Locations

Fisiopatologia Respiratoria

Trieste, TS, Italy

Countries

Italy

References

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. doi: 10.1016/j.ejcts.2007.05.031. Epub 2007 Jul 19.

Reference Type: BACKGROUND

PMID: 17658265 (View on PubMed)

Kodric M, Trevisan R, Torregiani C, Cifaldi R, Longo C, Cantarutti F, Confalonieri M. Inspiratory muscle training for diaphragm dysfunction after cardiac surgery. J Thorac Cardiovasc Surg. 2013 Mar;145(3):819-23. doi: 10.1016/j.jtcvs.2012.07.087. Epub 2012 Aug 29.

Reference Type: DERIVED

PMID: 22938776 (View on PubMed)

Other Identifiers

PN 001-08

Identifier Type: -

Identifier Source: secondary_id

SCPN-01-08

Identifier Type: -

Identifier Source: org_study_id