- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02711150
Effect of EPD on the Lumbar Acoustic Window at Term Pregnancy
5. marts 2018 opdateret af: Lawson Health Research Institute
Efficacy of the Epidural Positioning Device (EPD) on Optimising the Acoustic Target Window for Neuraxial Needle Placement
The purpose of this study is to assess whether application of an epidural positioning device to a parturient seated for neuraxial anaesthesia increase the size of the paramedian target area for neuraxial needle insertion.
Lumbar ultrasonography will be performed in 30 pregnant women in two seated positions: (P1), lumbar flexion; and (P2), as in P1 with the epidural positioning device applied.
For each position, the size of the 'target area', defined as the visible length of the posterior longitudinal ligament will be measured at the L3-L4 interspace.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
Thirty term pregnant women will be recruited.
Signed informed consent will be obtained from all subjects and demographic details, including age, weight, height and body mass index (BMI) will be documented.
Randomization and blinding: Randomization will not be performed in this study, because each patient is their own control Interventions: Two experienced operators who have previously performed several hundred landmark-guided and ultrasound-assisted neuraxial blocks will perform the clinical and ultrasound examination..
The patient will then be placed in each of the positions described below.
While in each of the positions an ultrasound (US) probe will be placed at level L3- L4 at the paramedian position to visualize the paravertebral longitudinal ligament (PLL) .
These measurements will be recorded by an observer.
In both phases (first US operator and second US operator ), 2 ultrasound measurements will be made for each of the following positions at 1 lumbar level in the paramedian view.
These measurements will be made with the patient in the following positions: • Sitting position, feet supported with back flexed.
• Sitting position, feet supported and arms supported through the application of an epidural positioning device.
All images will be assigned a number based on a random number generator to remove any identifying data, including volunteer number, date, time, and position.
The PLL will be remeasured on every saved image by two separate anesthesiologists ('readers') who are not involved with any previous data collection but are members of the study team.
Both will be blinded to the number allocation and each other's measured values.
This aim to remove any bias by the 'scanning' anesthesiologists and test for reproducibility in the measurement of the PLL, between 'readers'.
A statistician calculated a minimum sample size of 30 subjects, in order to demonstrate significant change in the mean length of the PLL (acoustic target area), in any of the two positions.
This estimation was based on data derived from a similar study, which had used a minimum sample size of 16 subjects, with a 1 mm mean change in 'needle target area' dimensions, a 1 mm standard deviation (SD), and an alpha of 0.05 with a power of 90 % [1, 2].
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
30
Fase
- Ikke anvendelig
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
Kvinde
Beskrivelse
Inclusion Criteria:
- Female Patients
- Term Pregnancy (>37 weeks)
- 18 years or older
- Non-labouring patients, admitted for a cesarean delivery
Exclusion Criteria:
- Allergy to ultrasound jelly
- Spinal Deformities
- Active Labour
- Presence of Epidural Catheter for Labour Analgesia
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: EPD Measurements
Intervention: PLL Length Measured through US will be done with the subject placed on the Epidural Positioning Device. |
The PLL will be measured for each allocated position: EPD or Flexed Position
Andre navne:
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Aktiv komparator: Flexed Position Measurements
Intervention: PLL Length Measured through US will be done with the subject placed in a "flexed" lumbar spine position. |
The PLL will be measured for each allocated position: EPD or Flexed Position
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Increase in PLL with the application of an EPD
Tidsramme: 12 months
|
12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Indu Singh, MD, FRCPC, Western University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Jones AR, Carle C, Columb M. Effect of table tilt on ligamentum flavum length measured using ultrasonography in pregnant women*. Anaesthesia. 2013 Jan;68(1):27-30. doi: 10.1111/anae.12006. Epub 2012 Oct 22.
- Grau T, Leipold RW, Horter J, Conradi R, Martin EO, Motsch J. Paramedian access to the epidural space: the optimum window for ultrasound imaging. J Clin Anesth. 2001 May;13(3):213-7. doi: 10.1016/s0952-8180(01)00245-8.
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)
3. maj 2016
Primær færdiggørelse (Faktiske)
7. oktober 2016
Studieafslutning (Faktiske)
7. oktober 2016
Datoer for studieregistrering
Først indsendt
26. januar 2016
Først indsendt, der opfyldte QC-kriterier
11. marts 2016
Først opslået (Skøn)
17. marts 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. marts 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. marts 2018
Sidst verificeret
1. marts 2018
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 107422
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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