Diaphragm Training Post-Cardiac Surgery - Full Text View

Sponsored by:	Ospedali Riuniti Trieste
Information provided by:	Ospedali Riuniti Trieste
ClinicalTrials.gov Identifier:	NCT00597298

Purpose

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	Intervention
Diaphragmatic Paralysis	Device: Threshold Device: sham threshold

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study
Official Title:	Randomized Controlled Trial on the Diaphragm Training With Threshold for Patient With Post-Cardiac Surgery Diaphragmatic Paralysis

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery Paralysis Surgery

U.S. FDA Resources

Further study details as provided by Ospedali Riuniti Trieste:

Primary Outcome Measures:

chest x-ray mobility of the diaphragm [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Maximal inspiratory pressure (MIP), cm H2O [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment:	48
Study Start Date:	January 2008
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: Sham Comparator	Device: sham threshold non-training physical activity

Arms

Assigned Interventions

1: Active Comparator

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.

2: Sham Comparator

Device: sham threshold

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597298

Locations

Italy, TS
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

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:	SC Pneumologia - Ospedali RIuniti di Trieste ( Marco Confalonieri/MD )
Study ID Numbers:	SCPN-01-08, PN 001-08
Study First Received:	January 9, 2008
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00597298 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by Ospedali Riuniti Trieste:

diaphragmatic paralysis
cardiac surgery
respiratory muscle training

Study placed in the following topic categories:

Paralysis
Signs and Symptoms
Respiratory Insufficiency
Respiratory Tract Diseases

Respiratory Paralysis
Respiration Disorders
Neurologic Manifestations

Additional relevant MeSH terms:

Paralysis
Signs and Symptoms
Respiratory Insufficiency
Respiratory Tract Diseases

Respiratory Paralysis
Nervous System Diseases
Respiration Disorders
Neurologic Manifestations

ClinicalTrials.gov processed this record on September 11, 2009