Diaphragm Training Post-Cardiac Surgery (DIATRACS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00597298
Recruitment Status : Completed
First Posted : January 18, 2008
Last Update Posted : February 4, 2009
Information provided by:
Ospedali Riuniti Trieste

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.

Condition or disease Intervention/treatment Phase
Diaphragmatic Paralysis Device: Threshold Device: sham threshold Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Official Title: Randomized Controlled Trial on the Diaphragm Training With Threshold for Patient With Post-Cardiac Surgery Diaphragmatic Paralysis
Study Start Date : January 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
inspiratory muscle training program using a pressure threshold device
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.
Other Names:
  • Threshold IMT, Respironics,Cedar Grove NJ, USA
  • HS730EU-010

Sham Comparator: 2 Device: sham threshold
non-training physical activity

Primary Outcome Measures :
  1. chest x-ray mobility of the diaphragm [ Time Frame: 6 and 12 months ]

Secondary Outcome Measures :
  1. Maximal inspiratory pressure (MIP), cm H2O [ Time Frame: 6 and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • heart failure
  • COPD
  • neuromuscular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00597298

Fisiopatologia Respiratoria
Trieste, TS, Italy, 34149
Sponsors and Collaborators
Ospedali Riuniti Trieste
Study Director: Maja Demsar, MD AOUTS
Study Chair: Marco Confaloniei, MD AOUTS

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Marco Confalonieri/MD, SC Pneumologia - Ospedali RIuniti di Trieste Identifier: NCT00597298     History of Changes
Other Study ID Numbers: SCPN-01-08
PN 001-08
First Posted: January 18, 2008    Key Record Dates
Last Update Posted: February 4, 2009
Last Verified: February 2009

Keywords provided by Ospedali Riuniti Trieste:
diaphragmatic paralysis
cardiac surgery
respiratory muscle training

Additional relevant MeSH terms:
Respiratory Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases