Clinical trial NCT02635906: Reduced in Bed Rest After Coronary Arteriography or Coronary Angioplasty
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: BED REST
CORONARY ANGIOPLASTY
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2015-12-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Back Pain, Lumber Pain and Muscle Pain
timeFrame: 1 hour after the bed rest
Secondary outcomes:
measure: Haematoma
timeFrame: 24 hours after the coronary angioplasty
measure: Bleeding
timeFrame: 24 hours after the coronary angioplasty
measure: Pseudoaneurysm, Arteriovenous Fistula: Retroperitoneal hematoma, Acute Arterial Occlusion:
timeFrame: 24 hours after the coronary angioplasty
measure: Urinary retention, Paresthesia
timeFrame: 1 hour after the bed rest
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital São Paulo - Cardiology Unit
Study officials:
affiliation: Federal University of São Paulo
name: VINICIUS B SANTOS, MASTER
role: STUDY_CHAIR
References: