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OpenTrials
Completed

NCT Number: NCT00418158

Pulmonary Complications After Heart Surgery.

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catharina Hospital

Eindhoven, 5623 EJ, Netherlands

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

use of Airlife (therapy)

Behavioral

Sponsors and collaborators

Lead sponsor

Catharina Ziekenhuis Eindhoven

Other

Registry information

Official study title

Pulmonary Complications After Heart Surgery

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jan 4, 2007
Registry last updated
Nov 10, 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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