Video-laryngoscope With a Novel Video-stylet for Difficult Intubation
8. august 2017 opdateret af: Rainer Lenhardt, University of Louisville
Feasibility of a Combined Use of a Video-laryngoscope With a Novel Video-stylet for Predicted Difficult Intubation
We propose to enroll 140 subjects scheduled for elective or urgent/emergent surgery with general anesthesia including endotracheal intubation.
Patients qualify for the trial if they are considered a difficult airway case as determined by measurement of common predictive indices for difficult intubation (see inclusion criteria).
All patients will be intubated with a GVL.
Patients will be randomly assigned to either having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group) or with a flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).
The randomization will be stratified as to whether patients are categorized as predicted difficult airway or have an immobilized cervical spine (C-collar in place).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
140
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Kentucky
-
Louisville, Kentucky, Forenede Stater, 40202
- University of Louisville 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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- BMI > 35
- Thyromental distance < 6 cm
- Sterno-mental distance < 12 cm
- Mallampati grade 3 and 4
- Interincisor distance < 38 mm
- Status of dentition: presence of buckteeth
- Neck movement < 35°
- Neck circumference >43 cm at the level of the thyroid cartilage
- Patients with immobilized cervical spine (C-collar in place).
- History of difficult laryngoscopy or intubation
Exclusion Criteria:
- Full stomach
- Hiatal hernia
- Severe GERD (Gastroesophageal reflux disease)
- Tumors of the upper airway
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Control
Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)
|
pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope
|
|
Eksperimentel: Intervention
Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).
|
The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Intubation Time
Tidsramme: 120 seconds
|
divided into time to successfully place the glidescope (visualization of the epiglottis), time to successfully insert the videostylet (passing through the cords) and time to verified placement of the ETT (as outlined above).
Interim bag and mask time, if needed, will not be included in the intubation time.
More than 5 attempts or 120 s are regarded as failure of intubation.
If failure to secure the airway occurs with the GVL and videostylet, then conventional difficult intubation protocols approved by the University of Louisville Hospital will be implemented.
|
120 seconds
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The Number of Intubation Attempts
Tidsramme: 30 minutes
|
counted as each approach of the ETT to the glottic entrance.
|
30 minutes
|
|
Neck Movement
Tidsramme: 30 minutes
|
One observer will video-record the entire intubation procedure.
At a later time, an otherwise unrelated observer will watch the video-records and grade the neck movement during intubation.
Neck movement will be classified as Grade 0: no neck movement, Grade 1: minimal neck movement, or Grade 2: moderate neck movement.
Results are reported as total with mild, moderate, or severe neck movement.
|
30 minutes
|
|
Laryngeal View Grade of 1 or 2
Tidsramme: 30 minutes
|
The laryngeal view as Grade 1 (full view of the glottis) or Grade 2 (glottis partly exposed, anterior commissure not seen) according to the method described by Cormack and Lehane (1984).
|
30 minutes
|
|
Ease of Intubation
Tidsramme: 2-4 hours after intubation
|
After completion of the procedure the intubator will be asked to score the ease of intubation.
To do this, he/she will give a score from 0-100 with 0 being the easiest and 100 being the hardest.
|
2-4 hours after intubation
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Rainer Lenhardt, MD, University of Louisville
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.
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. august 2010
Primær færdiggørelse (Faktiske)
1. oktober 2013
Studieafslutning (Faktiske)
1. december 2013
Datoer for studieregistrering
Først indsendt
22. juli 2010
Først indsendt, der opfyldte QC-kriterier
5. oktober 2010
Først opslået (Skøn)
6. oktober 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. september 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. august 2017
Sidst verificeret
1. august 2017
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- UofL IRB #10.0300
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 .