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Sponsored by: |
University of Florence |
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Information provided by: | University of Florence |
ClinicalTrials.gov Identifier: | NCT00670579 |
Pulmonary infections are the major cause of mortality and morbidity in cystic fibrosis (CF); patients frequently have to take antibiotics which often cannot be given orally or by aerosol but have to be administered intravenously. In order to reduce the number of venepunctures, totally implanted venous access devices (TIVAD) or Ports have been used to administer antibiotics and other infusions.
The use of Port systems has been increasing in recent years, especially for those patients requiring frequent intravenous treatments. Having a TIVAD in place makes venous access quicker and also reduces trauma, suffering and pain. However, there are important complications associated with TIVADs which can be early (pneumothorax, arterial puncture, severe bruising) or late (infections, thromboembolic complications and occlusion).
Although the use of TIVADs in CF is increasing, there is little CF-specific literature available on the epidemiology and risk of TIVAD complications. Also, literature is scarce about clinical criteria for deciding to insert a TIVAD. Therefore, so far clinical decisions were based mainly on experiences of TIVAD use in other diseases, such as cancer.
With this prospective observational study we will survey a large population of Italian CF people with TIVAD in order to: collect data about current clinical conditions of CF people with TIVAD; investigate about clinical criteria that led to the decision of positioning a TIVAD; observe the possible onset of late complications.
Condition |
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Cystic Fibrosis |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | A Prospective Study About Complications of Totally Implantable Central Venous Access Ports in People With CF |
Estimated Enrollment: | 80 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
To be included in the study, subjects need to fulfil the following requirements:
Measured outcomes will be:
The observational phase will last 12 months for each subject involved
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
People with CF and with a TIVAD implanted
Inclusion Criteria:
Contact: Alberto Dal Molin, BSN, MSN | alberto.dalmolin@gmail.com |
Italy, Tuscany | |
Cystic Fibrosis Center of Tuscany, Meyer Hospital | Recruiting |
Florence, Tuscany, Italy | |
Contact: Alberto Dal Molin, BSN,MSN alberto.dalmolin@gmail.com |
Responsible Party: | University of Florence ( Alberto Dal Molin ) |
Study ID Numbers: | FFC#30/2008 |
Study First Received: | April 30, 2008 |
Last Updated: | August 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00670579 |
Health Authority: | Italy: Ethics Committee |
TIVAD complications nursing cystic fibrosis implanted |
Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis Fibrosis |
Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases Cystic fibrosis |
Pathologic Processes |