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Pulmonary Complications After Heart Surgery.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00418158
First Posted: January 4, 2007
Last Update Posted: November 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Catharina Ziekenhuis Eindhoven
  Purpose

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 Intervention
Heart Surgery Behavioral: use of Airlife (therapy)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pulmonary Complications After Heart Surgery

Resource links provided by NLM:


Further study details as provided by Catharina Ziekenhuis Eindhoven:

Estimated Enrollment: 120
Study Start Date: December 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Euroscore < 8
  • Age > 18 year
  • Patients whereby ECC is peri-operatively used
  • No psychological history
  • Informed consent obtained
  • Follow -up at Catherina Hospital

Exclusion Criteria:

  • COPD
  • Mitral valve plasty or reconstruction
  • Off-pump
  • Cognitive problems
  • Expected comlpications during operation
  • Patients with decompensation
  • Day 5 post- ok thoracic drains insitu
  • Pain score grater than 4
  • Abnormal chest x-ray
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00418158


Locations
Netherlands
Catharina Hospital
Eindhoven, Netherlands, 5623 EJ
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Investigators
Principal Investigator: F.J. ter Woorst, MD Catharina Hospital Eindhoven, department of CardioThoracic Surgery. The Netherlands
  More Information

ClinicalTrials.gov Identifier: NCT00418158     History of Changes
Other Study ID Numbers: poho studie
First Submitted: January 3, 2007
First Posted: January 4, 2007
Last Update Posted: November 10, 2009
Last Verified: November 2009

Keywords provided by Catharina Ziekenhuis Eindhoven:
Pulmonary complications