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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01740856

Acronym

Three-Cath

Enrollment

730

Registered

2012-12-04

Start date

2011-01-31

Completion date

2014-02-28

Last updated

2016-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease With Myocardial Infarction

Keywords

cardiac catheterization, safety, nursing care, rest, Patients

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.

Interventions

OTHERRest 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.

OTHERRest 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Safety	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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026