- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02360163
The "Peripheral Access Utilizing Sonographic Evaluation" Study (PAUSE)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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New Jersey
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Hackensack, New Jersey, États-Unis, 07601
- Hackensack University Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Landmark Technique Attempt
Patients will undergo an additonal TLT attempt
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Expérimental: USGPIVA Technique Attempt
Patients will be offered a USGPIVA attempt after two failed attempts using the traditional landmark technique (TLT)
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
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
Délai: 1 Day
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1 Day
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Nancy Van Buitenen, MSN, APN, RN, Hackensack UMC
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- Pro 2921
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .