Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Reduced in Bed Rest After Coronary Arteriography or Coronary Angioplasty

5. januar 2018 oppdatert av: Vinicius Batista Santos, Federal University of São Paulo

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.

Studieoversikt

Status

Fullført

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

Intervensjonell

Registrering (Faktiske)

150

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

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:
  • reduced bed rest
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:
  • four hours group

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.
24 hours after the coronary angioplasty
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
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

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studiestol: VINICIUS B SANTOS, MASTER, Federal University of São Paulo

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2016

Primær fullføring (Faktiske)

1. desember 2017

Studiet fullført (Faktiske)

1. januar 2018

Datoer for studieregistrering

Først innsendt

30. november 2015

Først innsendt som oppfylte QC-kriteriene

18. desember 2015

Først lagt ut (Anslag)

21. desember 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. januar 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. januar 2018

Sist bekreftet

1. januar 2018

Mer informasjon

Begreper knyttet til denne studien

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere