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The "Peripheral Access Utilizing Sonographic Evaluation" Study (PAUSE)

1. august 2018 opdateret af: Hackensack Meridian Health
The purpose of this study is to reduce, by using the ultrasound guided technique, the minor surgical procedures that might be required to deliver fluids into the blood of critically ill patients simply because the patients' veins cannot be located through the manual technique.

Studieoversigt

Detaljeret beskrivelse

The purpose of this study is to reduce, by using the ultrasound guided technique, the minor surgical procedures that might be required to deliver fluids into the blood of critically ill patients simply because the patients' veins cannot be located through the manual technique.

The ultrasound assisted technique will increase accessibility to small veins that might be missed via the manual technique. The technique of using an ultrasound machine to assist the administration of fluids into a patient's veins is called ultrasound guided peripheral intravenous access (USGPIVA), while the traditional technique that uses only sight and touch to locate a patient veins without machine assistance is called the traditional landmark technique (TLT). The investigators will compare the effectiveness of USGPIVA with TLT in terms of reducing complications and costs.

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Hackensack University Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • The patient is >= 21 years of age
  • Adult critically ill patients in CCU and MICU requiring short peripheral intravenous access
  • The patient has been identified as difficult intravenous access (DIVA), defined as at least two failed blind sticks in the antecubital fossa or more distal upper arm veins
  • The patient does not otherwise require a CVC

Exclusion Criteria:

  • The patient has a PICC line on the same side as IV placement and has the following:

    • Has a condition poses risk for DIC, inadequate flow, or infection.
    • Has been identified as a site for "Save the Vein" protocol implementation, unless permission is otherwise obtained by the patient's physician.
    • Has a hemodialysis fistula in place on that upper arm side.
  • The patient is expected to require therapeutic agent or procedure that necessitates central venous access such as:

    • central venous monitoring
    • Total Parenteral Nutrition
    • Antibiotic requiring central venous access
    • Chemotherapy
    • Vesicants
    • Medications pH less than 5 or more than 9
    • Medications of glucose concentrations above 10%
    • Solution with protein concentrations above 5% (Vascular Access Management, n.d.)
  • The patient already has a central venous catheter access, for reasons other than DIVA, through which therapy can be infused
  • The patient has renal disease and a "Save The Vein" order is anticipated or pending (serum creatinine >2mg/dL and GFR <20) for one of the patient's arms, unless permission is otherwise obtained by the patient's physician
  • The patient has a bleeding disorder, unless permission is otherwise obtained by the patient's physician
  • The clinician believes the patient is not a good fit for the study or that the procedure is not appropriate for patient at the given moment

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Landmark Technique Attempt
Patients will undergo an additonal TLT attempt
Eksperimentel: USGPIVA Technique Attempt
Patients will be offered a USGPIVA attempt after two failed attempts using the traditional landmark technique (TLT)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Reduction in number of minor surgical procedures that may be required to deliver fluids into the blood of critically ill patients by using the ultrasound guided technique
Tidsramme: 1 Day
1 Day

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Nancy Van Buitenen, MSN, APN, RN, Hackensack UMC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2015

Primær færdiggørelse (Faktiske)

19. januar 2017

Studieafslutning (Faktiske)

19. januar 2017

Datoer for studieregistrering

Først indsendt

5. februar 2015

Først indsendt, der opfyldte QC-kriterier

9. februar 2015

Først opslået (Skøn)

10. februar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. august 2018

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • Pro 2921

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner