DIATRACS: Diaphragm Training Post-Cardiac Surgery

Sponsor

Ospedali Riuniti Trieste (Other)

Overall Status

Completed

CT.gov ID

NCT00597298

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Jan 1, 2008

Actual Primary Completion Date :

Jan 1, 2009

Actual Study Completion Date :

Jan 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

chest x-ray mobility of the diaphragm [6 and 12 months]

Secondary Outcome Measures

Maximal inspiratory pressure (MIP), cm H2O [6 and 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fisiopatologia Respiratoria	Trieste	TS	Italy	34149

Sponsors and Collaborators

Ospedali Riuniti Trieste

Investigators

Study Director: Maja Demsar, MD, AOUTS
Study Chair: Marco Confaloniei, MD, AOUTS

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00597298

Other Study ID Numbers:

SCPN-01-08
PN 001-08

First Posted:

Jan 18, 2008

Last Update Posted:

Feb 4, 2009

Last Verified:

Feb 1, 2009

Keywords provided by , ,

diaphragmatic paralysis

cardiac surgery

respiratory muscle training

Additional relevant MeSH terms:

Respiratory Paralysis

Paralysis

Study Results

No Results Posted as of Feb 4, 2009