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

NCT01740856 | Completed DMC

• 1 other identifier: UFRGS and HCPA 100401
• Study Type: interventional
• Target: 730
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease With Myocardial Infarction

Keywords

cardiac catheterization; safety; nursing care; rest; Patients

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Rest three hours

EXPERIMENTAL

Rest three hours

Other: Rest three hours

Rest five hours

EXPERIMENTAL

Rest five hours

Other: Rest five hours

Interventions

Rest three hours OTHER

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.

Rest three hours

Rest five hours OTHER

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.

Rest five hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035003, Brazil

Location

MeSH Terms

Conditions

Coronary Artery Disease, Autosomal Dominant, 1

Interventions

RE1-silencing transcription factor

Study Officials

• Eneida R Rabelo da Silva, Professor

  Hospital de Clinicas de Porto Alegre - Graduate Programa from Nursing School at Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

• Roselene Matte, RN, MSc

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, ScD

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: December 4, 2012
• Study Start: January 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: April 12, 2016

Record last verified: 2016-04

Locations

BR (1)