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Clinical Trials/NCT02635906
NCT02635906CompletedNot Applicable

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

Federal University of São Paulo1 site in 1 country150 target enrollmentStarted: March 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
150
Locations
1
Primary Endpoint
Back Pain, Lumber Pain and Muscle Pain

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

2 hours

Experimental

after coronary arteriography or coronary angioplasty, will be removal the introducer and the patient will be in bed rest for two hours

Intervention: 2 hours (Other)

4 hours

Active Comparator

after coronary arteriography or coronary angioplasty, will be removal the introducer and the patient will be in bed rest for four hours

Intervention: 4 hours (Other)

Outcomes

Primary Outcomes

Back Pain, Lumber Pain and Muscle Pain

Time Frame: 1 hour after the bed rest

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.

Secondary Outcomes

  • Bleeding(24 hours after the coronary angioplasty)
  • Haematoma(24 hours after the coronary angioplasty)
  • Pseudoaneurysm, Arteriovenous Fistula: Retroperitoneal hematoma, Acute Arterial Occlusion:(24 hours after the coronary angioplasty)
  • Urinary retention, Paresthesia(1 hour after the bed rest)

Investigators

Sponsor
Federal University of São Paulo
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Vinicius Batista Santos

Nursing Coordinator

Federal University of São Paulo

Study Sites (1)

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