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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Coronary Artery Disease With Myocardial Infarction

Intervention / Treatment
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* Other: Rest three hours
* Other: Rest five hours


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rest three hours<br>Rest three hours | Other: Rest three hours<br>* 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.<br>|
| Experimental: Rest five hours<br>Rest five hours | Other: Rest five hours<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | until three days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac catheterization, safety, nursing care, rest, Patients