Clinical trial NCT00418158: Pulmonary Complications After Heart Surgery.
Official title: Pulmonary Complications After Heart Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Surgery
Keywords: Pulmonary complications
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
First posted: 2007-01-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
Study officials:
affiliation: Catharina Hospital Eindhoven, department of CardioThoracic Surgery. The Netherlands
name: F.J. ter Woorst, MD
role: PRINCIPAL_INVESTIGATOR
References: