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Pulmonary Complications After Heart Surgery.

Pulmonary Complications After Heart Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00418158
Enrollment
120
Registered
2007-01-04
Start date
2005-12-31
Completion date
2008-01-31
Last updated
2009-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Surgery

Keywords

Pulmonary complications

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.

Interventions

BEHAVIORALuse of Airlife (therapy)

Sponsors

Catharina Ziekenhuis Eindhoven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026