Genauigkeit des Accuro 3S
Machbarkeit und Genauigkeit des Accuro 3S
The main purpose of this study is to evaluate the feasibility and accuracy of the Accuro 3S to provide live guidance when performing a neuraxial technique (e.g., spinal, or epidural).
The Accuro 3S is a new device that was designed to allow for midline live neuraxial guidance. If the device can perform as the manufacturers claim the device will permit the performance of epidurals as close as doing them under fluoroscopy.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Feasibility will be assessed in terms of how easily the device can be used and if it poses any discomfort to the patient. Live guidance is defined as the ability to see and change, if needed, the needle trajectory as it is advanced. Accuracy is defined as a measurement of depth by device versus the actual depth of the needle, number of needle attempts (skin punctures) and number of needle redirection.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Antonio Gonzalez-Fiol, MD
- Telefonnummer: 203-785-2802
- E-Mail: antonio.gonzalez-fiol@yale.edu
Studienorte
-
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Connecticut
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New Haven, Connecticut, Vereinigte Staaten, 06520
- Yale New Haven Hospital
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- The anesthetic plan for the patient includes a neuraxial anesthetic (spinal or epidural) as the main anesthetic for labor, surgery (e.g. orthopedic surgery, cesarean delivery) or for postoperative pain management (e.g, major abdominal surgery). *Given our labor and delivery volume (~300 epidurals/month) investigators think that they will only recruitc obstetric patients. In case of difficulty recruiting, then investigators will seek out a different patient population.
- No history of allergic reactions to adhesives used in standard epidural placements as per chart review or self-reported.
- Patient skin is intact in the area of placement of the epidural or spinal anesthesia.
- The patient is English speaking.
- For obstetric patients, the patient is admitted for cesarean delivery or for induction and is not in active labor. *Clarification - Patients scheduled for elective cesarean delivery will be approached for spinal anesthesia. Given that spinal anesthesia carries a smaller risk for post-dural puncture headache and other morbidities, investigators will recruit and perform 10 spinals on this patient population. Once comfortable with the technology, then will move to recruiting and performing epidurals. If during the spinal anesthesia trial the device does not provide accurate and clear needle visualization, the study will be culminated.
Exclusion Criteria:
- Contraindication to epidural catheter placement including bleeding diathesis (essential thrombocythemia, idiopathic thrombocytopenic purpura, von Willebrand disease, and hemophilia A or B), neurological dysfunction (multiple sclerosis, subacute myeloopticoneuropathy or preexisting lower limb neurological deficit), prior extensive spinal surgery or major spinal deformity, pre-operative use of anti-coagulant with planned use of therapeutic dose of anti-coagulant in post-operatively, documented pre-operative coagulopathy (INR greater than 1.3 not on Coumadin or PTT greater than 42), platelets less than 100, 000, or evidence of infection at potential epidural site.
- Presence of orthopedic implants in the spine.
- Skin dyscrasias or allergies to the ultrasound procedure.
- Unable to assume sitting position.
- Body Mass Index (BMI) less than 18.5 kg/m2.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Standard of Care and neuraxial guidance
Spinal or Epidural will be performed utilizing neuraxial guidance and standard of care techniques for placement. The spinal or epidural technique will not deviate from the standard of care. The device will only add the use of the disposable sterile drape and the use of the image will guide change of needle trajectory (without the need for contrast or radiation exposure) but not changing the technique. |
Provides anatomical guidance during the placement of needles or catheters using real-time visualization. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Mean number of needle attempts
Zeitfenster: At time of procedure, 1 day
|
Defined as the number of times the needle is inserted into patients back |
At time of procedure, 1 day
|
|
Mean number of needle redirections
Zeitfenster: At time of procedure, 1 day
|
Defined as number of needle movements in a cephalad, caudal or lateral position. |
At time of procedure, 1 day
|
|
Accuracy of device
Zeitfenster: At time of procedure, 1 day
|
The ultrasound device can be used to measure the distance from skin to epidural space, this will be recorded as the estimated distance to epidural space (EDES). Once the epidural space is accessed the needle will be marked and measured. This will represent the Distance to epidural space (DES). The difference between EDES and DES will provide the accuracy of the device. Mean distance in centimeters (cm). |
At time of procedure, 1 day
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Patient satisfaction
Zeitfenster: 20 minutes post procedure
|
Likert scale asking the patient "How satisfied are you with the procedure performed?" Very dissatisfied, dissatisfied, Satisfied, very satisfied, extremely satisfied. Total score range 1-5 with higher scores indicating more satisfaction. |
20 minutes post procedure
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Antonio Gonzalez-Fiol, MD, Yale University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2000036235
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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