- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02635906
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
-
São Paulo, Brasil, 04024-002
- Hospital São Paulo - Cardiology Unit
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 2 hours
after coronary arteriography or coronary angioplasty, will be removal the introducer and the patient will be in bed rest for two hours
|
BED REST FOR TWO HOURS AFTER CORONARY ARTERIOGRAPHY OR CORONARY ANGIOPLASTY
Andre navn:
|
|
Aktiv komparator: 4 hours
after coronary arteriography or coronary angioplasty, will be removal the introducer and the patient will be in bed rest for four hours
|
BED REST FOR FOUR HOURS AFTER CORONARY ARTERIOGRAPHY OR CORONARY ANGIOPLASTY
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Back Pain, Lumber Pain and Muscle Pain
Tidsramme: 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.
|
1 hour after the bed rest
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Haematoma
Tidsramme: 24 hours after the coronary angioplasty
|
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
Tidsramme: 24 hours after the coronary angioplasty
|
This outcome will be measured when appear blood in a bandage or when the haemoglobin decrease more than 3g/d.
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24 hours after the coronary angioplasty
|
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Pseudoaneurysm, Arteriovenous Fistula: Retroperitoneal hematoma, Acute Arterial Occlusion:
Tidsramme: 24 hours after the coronary angioplasty
|
This outcome will be measured in relation to presence or absence by ultrasound.
|
24 hours after the coronary angioplasty
|
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Urinary retention, Paresthesia
Tidsramme: 1 hour after the bed rest
|
This outcome will be measured in relation to presence or absence.
|
1 hour after the bed rest
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: VINICIUS B SANTOS, MASTER, Federal University of São Paulo
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 49068315.0.0000.5505
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