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

Primary Purpose

Coronary Artery Disease With Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Rest three hours
Rest five hours
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease With Myocardial Infarction focused on measuring cardiac catheterization, safety, nursing care, rest, Patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital de Clinicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Rest three hours

Rest five hours

Arm Description

Rest three hours

Rest five hours

Outcomes

Primary Outcome Measures

Safety
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.

Secondary Outcome Measures

Full Information

First Posted
October 29, 2012
Last Updated
April 10, 2016
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT01740856
Brief Title
Clinical Trial to Assess the Safety of Reducing the Time of Bed Rest After Cardiac Catheterization
Acronym
Three-Cath
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 Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease With Myocardial Infarction
Keywords
cardiac catheterization, safety, nursing care, rest, Patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
730 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rest three hours
Arm Type
Experimental
Arm Description
Rest three hours
Arm Title
Rest five hours
Arm Type
Experimental
Arm Description
Rest five hours
Intervention Type
Other
Intervention Name(s)
Rest three hours
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Rest five hours
Intervention Description
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 Measure Information:
Title
Safety
Description
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.
Time Frame
until three days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eneida R Rabelo da Silva, Professor
Organizational Affiliation
Hospital de Clinicas de Porto Alegre - Graduate Programa from Nursing School at Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roselene Matte, RN, MSc
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035003
Country
Brazil

12. IPD Sharing Statement

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Clinical Trial to Assess the Safety of Reducing the Time of Bed Rest After Cardiac Catheterization

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