The "Peripheral Access Utilizing Sonographic Evaluation" Study (PAUSE)
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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New Jersey
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Hackensack, New Jersey, Stati Uniti, 07601
- Hackensack University Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: Landmark Technique Attempt
Patients will undergo an additonal TLT attempt
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Sperimentale: USGPIVA Technique Attempt
Patients will be offered a USGPIVA attempt after two failed attempts using the traditional landmark technique (TLT)
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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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
Lasso di tempo: 1 Day
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1 Day
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Nancy Van Buitenen, MSN, APN, RN, Hackensack UMC
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Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- Pro 2921
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .