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"Neutral Head Position" and "Head-lift Position" for Orotracheal Intubation With "Trachway" Intubating Stylet in Adults

17. oktober 2016 opdateret af: Wei-Hung Chan, Tri-Service General Hospital

"Neutral Head Position" and "Head-lift Position" for Orotrachwal Intubation With "Trachway" Intubating Stylet in Adults

The purpose of this study is to investigate two different patient's head and neck positions(neutral head position and head-lift position) for the effectiveness of orotracheal intubation with using the "Clarus Video System (Trachway®)" intubating stylet.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The sniffing position has traditionally been considered the optimal head position for direct laryngoscopy, However, it may aggravate cervical spine injury. The Trachway® video stylet is an intubating device that may avoid cervical movement during intubation. Nonetheless, the effectiveness of limited neck movement in patients with neutral head or head-lift position using the Trachway® video stylet remains unclear. The purpose of this study was to compare the intubation time of the two positions with the Trachway® video stylet.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

130

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Taiwan
      • Taipei, Taiwan, 114
        • Tri-Service General Hospital

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

20 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • patients scheduled for various surgeries requiring general anesthesia with tracheal intubation
  • American Society of Anesthesiologists(ASA) physical status classification I-III

Exclusion Criteria:

  • pneumothorax
  • room air saturation by pulse oximeter saturation less than 96%
  • vocal cord palsy
  • craniofacial anomaly
  • congenital upper airway anomaly
  • upper airway disease
  • cervical spine pathology
  • head and neck tumor status post radiotherapy
  • an increased risk of regurgitation or pulmonary aspiration
  • a history of difficult tracheal intubation

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Head-lift Position
The patients' head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients' head with head in neutral position) and then the patient was intubated with Trachway by single-handed chin lift technique
Procedure: Head-lift position
A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.
Enhed: 7cm high pillow
A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.
Ingen indgriben: Neutral Position
The patients' head was placed in the neutral position and then the patient was intubated with Trachway by single-handed chin lift technique

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Intubation Time
Tidsramme: from the intubating stylet touched the mouth to the capnogram shown, up to 30 seconds, and the sum of all attempts
the interval from the intubating stylet touched the mouth to capnogram shown, with all attempts, and was recorded by an independent observer with a stop watch.
from the intubating stylet touched the mouth to the capnogram shown, up to 30 seconds, and the sum of all attempts

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Modified Cormack-Lehane Grade
Tidsramme: during intubation, after epiglottis was identified on the video monitor

The laryngeal view was graded by the observer with modified Cormack-Lehane grade after epiglottis was identified on the video monitor.

Scale range (1, 2, 3, 4). Grade 1 is considered to be a better outcome while grade 4 is considered to be a worse outcome.
during intubation, after epiglottis was identified on the video monitor
Mean Arterial Pressure
Tidsramme: before and after intubation, up to 5 minutes
compare the mean arterial pressure between two groups.
before and after intubation, up to 5 minutes
Visual Analog Scale of Sore Throat
Tidsramme: after anesthesia emergence 30 minutest, at post-anesthesia care unit

All patients were asked to rate the degree of sore throat, using a visual analogue scale after anesthesia emergence in the post-anesthesia care unit.

Scale range: 0-10. 0 is considered to be a better outcome while 10 is a worse outcome.
after anesthesia emergence 30 minutest, at post-anesthesia care unit

Samarbejdspartnere og efterforskere

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

Sponsor

Tri-Service General Hospital

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

1. december 2014

Primær færdiggørelse (Faktiske)

1. oktober 2015

Studieafslutning (Faktiske)

1. oktober 2015

Datoer for studieregistrering

Først indsendt

13. oktober 2015

Først indsendt, der opfyldte QC-kriterier

16. oktober 2015

Først opslået (Skøn)

19. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. december 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. oktober 2016

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 2-103-05-125

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Intubation; Svært

Kliniske forsøg med Head-lift position

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Belarus

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner