Pulmonary Complications After Heart Surgery.
|ClinicalTrials.gov Identifier: NCT00418158|
Recruitment Status : Completed
First Posted : January 4, 2007
Last Update Posted : November 10, 2009
Abstract: Post-operative pulmonary complications after cardiac surgery
Background The Catharina Hospital performs approximately 1700 heart operation each year. One third of the patients stay at the Catharina hospital during their entire post-operative period. Two years ago they abolished the pulmonary support by a physiotherapist. Subjectively, the pulmonary complications increased over the last two years. During an investigation of the contentment of the patients an increase of the pulmonary problems came forward after eliminating the pulmonary support. There have been no further examinations to the pulmonary complications post-operatively.
Objectives The aim of this study is to give the department of cardio-thoracic surgery an advice about the post-operative pulmonary support for patients who underwent heart surgery.
During the study a budgetary analysis will be made.
Methods 120 patients are prospectively randomised in three groups. Randomisation takes place through block randomisation every three weeks. 40 patients will be supported by a physiotherapist. Another 40 patients will be supported by the nurses on the cardiothoracic surgery ward and the last 40 patients will use an incentive therapy with 'Airlife' by a self-management method.
The study population are all patients undergoing heart surgery and spend their entire post-operative period at the Catharina Hospital. In- and exclusion criteria are specified in the protocol on pages 3 and 4.
Outcome The primary outcome is to qualify the pulmonary complications within the three groups. These complications will be objectified by measuring peak flow, an instrument to determine the lung function, and an x-ray of the thorax.
The secondary outcome is the contentment of the patient, which will be determined by a VAS-score (Visual Analogue Scale).
Risks There are no risks for the patient when participating on this study. The patient will have to fill in the VAS-score and measure lung function with the peak flow at two different moments. The study takes place in a clinical setting. There is no extra insurance in conformity with the advice of the METC.
|Condition or disease||Intervention/treatment|
|Heart Surgery||Behavioral: use of Airlife (therapy)|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pulmonary Complications After Heart Surgery|
|Study Start Date :||December 2005|
|Primary Completion Date :||January 2008|
|Study Completion Date :||January 2008|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00418158
|Eindhoven, Netherlands, 5623 EJ|
|Principal Investigator:||F.J. ter Woorst, MD||Catharina Hospital Eindhoven, department of CardioThoracic Surgery. The Netherlands|