Clinical Trial to Assess the Safety of Reducing the Time of Bed Rest After Cardiac Catheterization (Three-Cath)
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|ClinicalTrials.gov Identifier: NCT01740856|
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : April 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease With Myocardial Infarction||Other: Rest three hours Other: Rest five hours||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||730 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Clinical Trial to Assess the Safety of Reducing the Time of Bed Rest Within Five to Three Hours After Diagnostic Cardiac Catheterization With a 6F Sheath|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||February 2014|
Experimental: Rest three hours
Rest three hours
Other: Rest three hours
Intervention group (IG), will maintain bed rest supine for two hours after the digital compression. After this period prescribed, patients sit in bed with the head elevated at 45 degrees for 50 minutes and then walk within the unit hemodynamic for about 10 minutes. Afterwards patients remain sitting out of bed in hemodynamics unit, until they are five hours, then they will be discharge.
Experimental: Rest five hours
Rest five hours
Other: Rest five hours
Control group (CG) maintain bed rest supine for four hours after the digital compression. After this period, the patients sit in bed with the head elevated at 45 degrees for 50 minutes and then walk into the unit hemodynamic for 10 minutes. After that patients receive discharge.
- Safety [ Time Frame: until three days ]Bleeding: seen after the femoral compression after walking and after sitting down ;Hematoma, pseudoaneurysm and bruise: at the site of arterial puncture;vaso-vagal reaction. All of these will be monitoring by telephone contact at 24h, 48h and 72 hours.
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): NCT01740856
|Hospital de Clinicas de Porto Alegre|
|Porto Alegre, RS, Brazil, 90035003|
|Principal Investigator:||Eneida R Rabelo da Silva, Professor||Hospital de Clinicas de Porto Alegre - Graduate Programa from Nursing School at Federal University of Rio Grande do Sul|
|Principal Investigator:||Roselene Matte, RN, MSc||Hospital de Clinicas de Porto Alegre|