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Ultrasound Guided Cricoid and Paralaryngeal Pressure

18. marts 2020 opdateret af: Dr Lim Siu Min, University of Malaya

Impact of Ultrasound Guidance on the Performance of Accurate Cricoid and Paralaryngeal Pressure

The primary objective is to study impact of upper airway ultrasonography in guiding anaesthetic assistant into providing accurate cricoid pressure, or both cricoid and paralaryngeal pressure in those with oesophagus deviation, achieving sonographic proven oesophageal occlusion compared to those without ultrasound guidance.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

All patients consented for the study were having their airway examined via US. Cross sectional sonography of the airway was performed to determine the anatomic relationship of the oesophagus relative to the trachea:

  1. before induction of anaesthesia
  2. after GA before external airway pressure manoeuvre
  3. after GA with external airway pressure manoeuvre.

US guided CP was applied on subjects with central oesophagus; CP and PLP were applied on subject with eccentric oesophagus anatomy.

PLP was performed by lateral compression on the eccentric oesophagus by fingertips under US guidance. To standardised the application of CP and PLP, only 2 well trained investigators were allowed to performed the CP and PLP, US scan on airway and patient recruitment. The conduct of trial involved 2 investigators where first investigator provide US scan, and second investigator provide compression of CP or PLP using fingertips guided by the instruction of first investigator.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

51

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre

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

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Elective list Under general anaesthesia Not intubated prior to OT

Exclusion Criteria:

Below 18 years old Pregnant Neck deformities Previous maxillofacial surgery

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Centrally located oesophagus post GA
Oesophagus remained central after general anaesthesia, cricoid pressure applied by fingertips under ultrasound guidance
cricoid pressure by fingertips applied under ultrasound guidance
Eksperimentel: Eccentric located oesophagus post GA
Oesophagus eccentric located after general anaesthesia, paralaryngeal pressure and cricoid pressure applied by fingertips under ultrasound guidance
cricoid pressure with paralaryngeal pressure by fingertips applied under ultrasound guidance

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The number of patients with eccentric oesophagus under general anesthesia, successfully occluded by using cricoid and paralaryngeal pressure.
Tidsramme: ultrasound assessment of oesophagus done after general anaesthesia, during application of cricoid pressure, and during application of cricoid and paralaryngeal pressure
we are studying the effectiveness of cricoid pressure versus cricoid and paralaryngeal pressure(novel technique) in those patients with eccentric oesophagus under general anaesthesia. We use ultrasound to determined the position of the oesophagus after patient under general anaethesia ( to group them under central oesophagus and eccentric oesophagus) and also to determine the success of oesophagus occlusion.
ultrasound assessment of oesophagus done after general anaesthesia, during application of cricoid pressure, and during application of cricoid and paralaryngeal pressure

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The number of patients with central oesophagus under general anesthesia, successfully occluded by using cricoid pressure.
Tidsramme: ultrasound assessment of oesophagus done after general anaesthesia and during application of cricoid pressure
The objective is to study the effectiveness of cricoid pressure in those patients with central oesophagus under general anaesthesia. We use ultrasound to determined the position of the oesophagus after patient under general anaethesia, and also to determine the success of oesophagus occlusion.
ultrasound assessment of oesophagus done after general anaesthesia and during application of cricoid pressure

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
incidence of variation of oesophagus position before and after general anaesthesia
Tidsramme: ultrasound assessment of position of oesophagus before and after general anaesthesia
We use ultrasound to determine the position of osephagus (central or eccentric) to determine the incidence of variation of oesophagus position before and after general anaesthesia.
ultrasound assessment of position of oesophagus before and after general anaesthesia

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Siu Min Lim, M. Anaes, University of Malaya

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

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. februar 2019

Primær færdiggørelse (Faktiske)

30. maj 2019

Studieafslutning (Faktiske)

31. juli 2019

Datoer for studieregistrering

Først indsendt

9. november 2019

Først indsendt, der opfyldte QC-kriterier

18. marts 2020

Først opslået (Faktiske)

23. marts 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. marts 2020

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2018118-6867
  • 45835 (National Medical Research Register)

Plan for individuelle deltagerdata (IPD)

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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med cricoid pressure

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