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Ultrasonographic Identification of the Proximal Humerus Landmarks

16. september 2020 opdateret af: SergioB17, The Cleveland Clinic

Ultrasonographic Identification of the Proximal Humerus Landmarks for Intra-Osseous Vascular Access Across Different Body Habitus

Evaluate whether discrete landmarks of the proximal humerus can be identified using ultrasound in patients with various body habitus and BMI.

Studieoversigt

Detaljeret beskrivelse

There are three main forms of vascular access: peripheral intravenous (PIV), Central venous (CV) and intraosseous (IO). Of the different types of vascular access PIV and CV access have drawbacks when used during resuscitation, because they can be difficult to obtain when patients are volume depleted as in cases of trauma. Attempting CV access has numerous risks with complications occurring in up to 33% of attempts. These include failed placement (22%), arterial puncture (5%), catheter malposition (4%), pneumothorax (1%) and asystolic cardiac arrest (<1%). Attempting to obtain CV access may also disrupt chest compressions in cases of cardiac arrest. Intraosseous access has been used in scenarios where PIV and CV access is difficult or impossible to obtain. Pharmacokinetic studies and standard practice support the bioequivalence of intraosseous and intravenous administration of common medications. Intravascular depletion does not hinder attempts at IO access, and as the insertion sites are peripheral to the heart, insertion can be done avoiding interruptions in chest compressions. Obtaining proximal humerus interosseous (PHIO) access may also be faster than obtaining both PIV and CV access with a relatively low complication rate. In one survey, complications of IO included difficulty in identifying correct anatomical site (3%), extravasation (3.7%), displacement after insertion (8.5%), and very rarely late complications including compartment syndrome (0.6%), osteomyelitis (0.4%) and skin infection (0.3%).

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

30

Kontakter og lokationer

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

Studiesteder

    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Participants will be selected after chart review of current patients undergoing general, cardiac, thoracic, or vascular surgery. Patients will be approached in the preoperative clinic or during their hospitalization (preoperatively or postoperatively). Informed consent will be obtained prior to performing the study.

Participants will be separated into 3 cohorts based on BMI. The number of participants in each cohort is as follows: 10 patients with BMI 18.5 - 25 kg/m2; 10 patients with BMI 30-35 kg/m2, 10 patients with BMI > 40 kg/m2.

Beskrivelse

Inclusion Criteria:

  • Males or females 18 years of age or older undergoing general, cardiac, thoracic or vascular surgery.
  • BMI >= 18.5 kg/m^2

Exclusion Criteria:

  • Limited mobility/ range of motion of arms
  • Prior surgical intervention on shoulder or humerus
  • History of arm dislocation with internal rotation
  • History of arm fracture
  • BMI in ranges: 25.1 - 29.9, 35.1 - 39.9

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Low BMI
Ultrasonographic identification of proximal humerus landmarks for patients with BMI 18.5 - 25 kg/m2
The study team will perform an ultrasonographic exam of the proximal humerus to identify six anatomical landmarks
Regular ultrasound machine used at Cleveland Clinic
Moderate BMI
Ultrasonographic identification of proximal humerus landmarks for patients with BMI 30-35 kg/m2 will receive ultrasound exam.
The study team will perform an ultrasonographic exam of the proximal humerus to identify six anatomical landmarks
Regular ultrasound machine used at Cleveland Clinic
High BMI
Ultrasonographic identification of proximal humerus landmarks for patients with BMI > 40 kg/m2 will receive ultrasound exam.
The study team will perform an ultrasonographic exam of the proximal humerus to identify six anatomical landmarks
Regular ultrasound machine used at Cleveland Clinic

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of proximal humerus landmarks successfully identified by ultrasound exam
Tidsramme: Through completion of ultrasonographic exam, an average of 30 minutes.

Two investigators will perform an ultrasonographic exam on each patient, with one investigator examining each side of the body. Each investigator will aim to identify 6 anatomical landmarks:

  1. The humeral shaft,
  2. The surgical neck of the humerus,
  3. The lesser tubercle,
  4. The greater tubercle,
  5. The intertubercular sulcus
  6. The target site in the greater tubercle for needle insertion. Each side will receive a score ranging from 0 to 6 corresponding to the number of landmarks correctly identified.
Through completion of ultrasonographic exam, an average of 30 minutes.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time used to identify all 6 anatomical landmarks using ultrasound in seconds.
Tidsramme: Through completion of ultrasonographic exam, an average of 30 minutes.
Evaluate the time used to identify all 6 anatomical landmarks using ultrasound.
Through completion of ultrasonographic exam, an average of 30 minutes.
Depth of each landmark from the skin in centimeters.
Tidsramme: Through completion of ultrasonographic exam, an average of 30 minutes.
Depth of each landmark from the skin in centimeters based on ultrasound measurements.
Through completion of ultrasonographic exam, an average of 30 minutes.

Samarbejdspartnere og efterforskere

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

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 (Faktiske)

1. april 2017

Primær færdiggørelse (Faktiske)

19. oktober 2019

Studieafslutning (Faktiske)

7. juli 2020

Datoer for studieregistrering

Først indsendt

23. marts 2017

Først indsendt, der opfyldte QC-kriterier

17. april 2017

Først opslået (Faktiske)

20. april 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. september 2020

Sidst verificeret

1. august 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 16-1642

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Ultrasonographic exam

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