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Completed

NCT Number: NCT00597298

Diaphragm Training Post-Cardiac Surgery

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.

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Key information

Conditions

Diaphragmatic Paralysis Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Paralysis Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fisiopatologia Respiratoria

Trieste, TS, 34149, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • heart failure
  • COPD
  • neuromuscular disease

Treatment and study plan

Threshold

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.

Other names: Threshold IMT, Respironics,Cedar Grove NJ, USA, HS730EU-010

sham threshold

Device

non-training physical activity

Primary outcomes

  1. chest x-ray mobility of the diaphragm

    Time frame: 6 and 12 months

Secondary outcomes

  1. Maximal inspiratory pressure (MIP), cm H2O

    Time frame: 6 and 12 months

Sponsors and collaborators

Lead sponsor

Ospedali Riuniti Trieste

Other

Registry information

Official study title

Randomized Controlled Trial on the Diaphragm Training With Threshold for Patient With Post-Cardiac Surgery Diaphragmatic Paralysis

Acronym: DIATRACS

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 18, 2008
Registry last updated
Feb 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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