Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Trial to Assess the Safety of Reducing the Time of Bed Rest After Cardiac Catheterization (Three-Cath)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01740856
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : April 12, 2016
Sponsor:
Information provided by (Responsible Party):
Eneida Rejane Rabelo da Silva, Hospital de Clinicas de Porto Alegre

Brief Summary:
Reducing the rest time after diagnostic cardiac catheterization for three hours does not increase the complications concerning to the procedure, compared to the rest of five hours.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease With Myocardial Infarction Other: Rest three hours Other: Rest five hours Not Applicable

Detailed Description:
Reducing the rest time after diagnostic cardiac catheterization for three hours does not increase the complications concerning to the procedure, compared to the rest of five hours. The aim of this study is to compare through a randomized clinical trial to reduce the rest time in bed for five hours after elective diagnostic cardiac catheterization, with a 6F sheath with a transfemoral approach, for a period of three hours of the occurrence of bleeding, hematoma, pseudoaneurysm and a vasovagal reaction.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 730 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age equal too or above 18 years
  • patients undergoing elective diagnostic cardiac catheterization on an outpatient basis and
  • who agree to participate by reading and signing the informed consent form.

Exclusion Criteria:

  • patients with restriction ambulation;
  • users of coumarin anticoagulants;
  • IMC greater than 35 kg/m2;
  • patients with hypertension (systolic PA > 180 mmHg and diastolic PA > 110 mmHg) at the end of the procedure

Information from the National Library of Medicine

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


Locations
Layout table for location information
Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035003
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: Eneida Rejane Rabelo da Silva, Professor, ScD, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01740856    
Other Study ID Numbers: UFRGS and HCPA 100401
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: April 12, 2016
Last Verified: April 2016
Keywords provided by Eneida Rejane Rabelo da Silva, Hospital de Clinicas de Porto Alegre:
cardiac catheterization
safety
nursing care
rest
Patients
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases