Diaphragm Training Post-Cardiac Surgery (DIATRACS)

This study has been completed.
Sponsor:
Information provided by:
Ospedali Riuniti Trieste
ClinicalTrials.gov Identifier:
NCT00597298
First received: January 9, 2008
Last updated: February 3, 2009
Last verified: February 2009
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Randomized Controlled Trial on the Diaphragm Training With Threshold for Patient With Post-Cardiac Surgery Diaphragmatic Paralysis

Resource links provided by NLM:


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
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

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
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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marco Confalonieri/MD, SC Pneumologia - Ospedali RIuniti di Trieste
ClinicalTrials.gov Identifier: NCT00597298     History of Changes
Other Study ID Numbers: SCPN-01-08, PN 001-08
Study First Received: January 9, 2008
Last Updated: February 3, 2009
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on April 17, 2014