- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01757314
Comparing Palpation Guided and Ultrasound Guided Arterial Line Placement
A Prospective Study Comparing Palpation Guided and Ultrasound Guided Arterial Catheter Placement by Anesthesiology Residents in Training
When surgery is performed under general anesthesia, a catheter is placed in a vein to administer drugs and saline. During major operations, an additional catheter is placed in an artery in order to measure the blood pressure closely and withdraw blood samples at frequent intervals for various laboratory tests. This arterial catheter is usually placed by feeling the patient's artery at the wrist and inserting the guide-needle in a blind fashion. This procedure, at times, leads to delays and failures due to an inability to feel the arterial pulsation well either due to the patients' anatomy or the anesthetic effect. This study will determine whether training Anesthesiology Residents in the use of ultrasound technology and its application in identifying an artery can prevent the problems associated with the conventional palpation technique. Our finding will lead to better and safer anesthetic management of patients presenting for a major surgical procedure. Furthermore, the finding will help us in introducing the education and training of ultrasound-guided arterial catheter placement in our Residency Program.
The investigators propose to follow anesthesia residents over a course of 3 years assessing their skill level for both palpation and ultrasound technique.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This is an updated study on a previous IRB-approved research (0120070296) which was terminated prior to conclusion as the principal investigator terminated his employment at the UNDNJ. An arterial catheter is routinely placed immediately following induction of anesthesia, in major operative procedures, in order to measure blood pressure continuously, perform frequent blood-gas analysis and withdraw blood for repeated laboratory testing. The arterial catheter is traditionally placed blindly by palpating the radial artery of the patient. This way of placing a radial artery catheter can encounter delay or failure due to conditions such as obesity, arteriosclerosis, arterial spasm and anesthesia-induced hypotension. Our study will compare the performance of Anesthesiology Residents in placing an arterial catheter by the traditional palpation-guided technique and by the ultrasound-guided technique after training in ultrasound usage. The comparison will utilize the following parameters:
- Time taken to successfully place a catheter
- Number of attempts needed to place a catheter
- Number of puncture site changes encountered
- Failure rate of the resident with each technique
- The need for replacement of the catheter during surgery The data collection will be done by an independent observer, who is not a member of the anesthesia care team or research team. The Residents performing the catheter placement will not be members of the research team and will not have access to the data. If the Resident fails to place the catheter, the attending anesthesiologist will rescue by placing the arterial catheter himself by a method of his choice. In the previous study, there was a trend toward a reduced failure rate and a decreased time for insertion with the ultrasound technique. In this study, the investigators will introduce the research to the first-year Residents and repeat the exercise during their second and third year of training in a longitudinal fashion to assess the progress during anesthesia training. The investigators plan to enroll eight residents from the first-year class. Each resident will perform eight arterial catheter placements with each technique. In addition, compared to the previous study, a more advanced ultrasound machine will be used which will provide better visualization of the radial artery.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
New Jersey
-
Newark, New Jersey, Vereinigte Staaten, 07101
- University Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- resident in training is agreeable to consent
Exclusion Criteria:
- None
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
---|---|
CA 1 and 2 anethesia residents
palpation technique
|
placement of a line via palpation technique
|
Ca1 and 2 residents
ultrasound guided technique
|
instruction in the ultrasound technique
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
time to successful placement of catheter
Zeitfenster: residents to be timed over 2 years
|
residents to be timed over 2 years
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 2012001193
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur palpation technique
-
Samuel Lunenfeld Research Institute, Mount Sinai...AbgeschlossenSchwierigkeiten beim AtmenKanada
-
University of UtahAbgeschlossenTriggerpunktschmerzen, myofaszial
-
University of Sao PauloUnbekanntBeckenbodenerkrankungenBrasilien
-
Academisch Medisch Centrum - Universiteit van Amsterdam...ZonMw: The Netherlands Organisation for Health Research and DevelopmentAbgeschlossenNeoplasien der Gallenblase | Cholezystektomie | Appendix-Neubildungen | Anhang | Blinddarmoperation | GallenblaseNiederlande
-
University of Alabama at BirminghamAbgeschlossenFettleibigkeit | Epiduralanästhesie | Ultraschall der WirbelsäuleVereinigte Staaten
-
Necmettin Erbakan UniversityUnbekanntMyofasziale SchmerzenTruthahn
-
Great Ormond Street Hospital for Children NHS Foundation...AbgeschlossenKoniotomieVereinigtes Königreich
-
University of California, IrvineLenox Hill Hospital; Jamaica Hospital Medical Center; Oklahoma City VA Medical...AbgeschlossenKoronare HerzkrankheitVereinigte Staaten
-
Institut des Hautes Etudes Osteopathiques de NantesNoch keine Rekrutierung
-
Eslam Elsayed Ali ShohdaNoch keine RekrutierungAbzugsfinger | Gültigkeit der Palpation