Reduced in Bed Rest After Coronary Arteriography or Coronary Angioplasty

Effectiveness of Reduced in Bed Rest After Coronary Arteriography or Coronary Angioplasty in Patients With Acute Coronary Syndrome: 4 Hours Versus 2 h.Clinical Trial

This is a randomized clinical trial with a control group, based on the guidelines of the CONSORT 2010. The interventional group will be in a bed rest for two hours after introducer removal in patients submitted a coronary arteriography or coronary angioplasty and the control group will follow the standard nursing care for four hours.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Other: 2 hours; Other: 4 hours

Detailed Description

This is a randomized clinical trial with a control group, based on the guidelines of the CONSORT 2010. It will be held in the cardiology unit of a public hospital in the city of São Paulo in patients admitted with Acute Coronary Syndrome undergoing coronary arteriography or coronary angioplasty by femoral arterial. Patients with hemodynamic instability will be excluded before and after the ATC, patients using oral anticoagulants presenting INR greater than 2; patients using inhibitors IIB / IIIa; patients with history of blood dyscrasias; patients undergoing invasive procedure again less than 24 hours; patients with previous diagnosis of arterial insufficiency and patients at the time of withdrawal of the introducer presenting systolic blood pressure greater than 180 mmHg and diastolic than 100 mmHg. After removing the introducer the interventional group will be in a bed rest for two hours and the control group will follow the standard nursing care for four hours. Will be assessed the following indicators: bruising, bleeding, pedis pulse and popliteal, presence of blast at the puncture site after removal of the introducer, peripheral perfusion, presence of pulsatile mass, back pain, low back pain, paresthesias, urinary retention, muscle aches, use of painkillers and erythrocyte level.

These indicators will be assessed prior to the procedure, immediately after removing the introducer, 6 hours after the removal of the introducer, 12 hours after removal of the introducer and 24 hours after removal of the introducer. Vascular outcomes will be considered the appearance of bruising, bleeding, pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma and acute arterial occlusion. Related to patient outcomes will be considered the complaints back pain, back pain, muscle pain, paresthesia and urinary retention. The assessment team will be composed of three nurses specialists in cardiology with a minimum of one year experience in patient care after the ATC. For this study will be presented by the principal investigator to the patient the study objectives, possible risks and complications and the study protocol, and if the patient agrees to participate in it will be delivered the Statement of Consent. The collected data regarding the patients included in the survey will be entered initially in a Microsoft Excel® 2010 software and later transferred to an electronic database software SPSS (Statistical Package for Social Sciences) version 20.0 and, then submitted to descriptive statistical analysis and comparison analysis between groups.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 04024-002
    • Hospital São Paulo - Cardiology Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients admitted with Acute Coronary Syndrome undergoing coronary arteriography or coronary angioplasty by femoral arterial.

Exclusion Criteria:

• patients with hemodynamic instability will be excluded before and after the ATC,
• patients using oral anticoagulants presenting INR greater than 2;
• patients using inhibitors IIB / IIIa;
• patients with history of blood dyscrasias;
• patients undergoing invasive procedure again less than 24 hours;
• patients with previous diagnosis of arterial insufficiency.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2 hours; after coronary arteriography or coronary angioplasty, will be removal the introducer and the patient will be in bed rest for two hours	Other: 2 hours; BED REST FOR TWO HOURS AFTER CORONARY ARTERIOGRAPHY OR CORONARY ANGIOPLASTY; Other Names: reduced bed rest
Active Comparator: 4 hours; after coronary arteriography or coronary angioplasty, will be removal the introducer and the patient will be in bed rest for four hours	Other: 4 hours; BED REST FOR FOUR HOURS AFTER CORONARY ARTERIOGRAPHY OR CORONARY ANGIOPLASTY; Other Names: four hours group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Back Pain, Lumber Pain and Muscle Pain	This outcome will be measured in relation to presence or absence. The presence and will Assess by means of a visual analog scale of 0 to 10, whereas the smallest value as no pain and the largest value as unbearable pain.	1 hour after the bed rest

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haematoma	This outcome will be measured in relation to presence or absence. The presence and will measured with a millimeter ruler taking.	24 hours after the coronary angioplasty
Bleeding	This outcome will be measured when appear blood in a bandage or when the haemoglobin decrease more than 3g/d.	24 hours after the coronary angioplasty
Pseudoaneurysm, Arteriovenous Fistula: Retroperitoneal hematoma, Acute Arterial Occlusion:	This outcome will be measured in relation to presence or absence by ultrasound.	24 hours after the coronary angioplasty
Urinary retention, Paresthesia	This outcome will be measured in relation to presence or absence.	1 hour after the bed rest

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Study Chair: VINICIUS B SANTOS, MASTER, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: November 30, 2015
• First Submitted That Met QC Criteria: December 18, 2015
• First Posted (Estimate): December 21, 2015

Study Record Updates

• Last Update Posted (Actual): January 8, 2018
• Last Update Submitted That Met QC Criteria: January 5, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: BED REST; CORONARY ANGIOPLASTY
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: 49068315.0.0000.5505