- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02679027
Difficult Intubation and Tongue Protrusion
New Test for Prediction of Difficult Intubation: Tongue Protrusion Movements
Objectives: The aim of study is to determine the possible usage of tongue movements out of the mouth in the prediction of difficult intubation.
Method: Two hundred twenty three patients undergoing abdominal surgery with general anesthesia between 2014 and 2015 were enrolled in this study. Difficult intubation was evaluated using the intubation difficulty scale (IDS) score. All intubations were performed by anesthesiologist to eliminate the differences among the anesthesiologists' experiences. IDS score were evaluated by anesthesiologists who had no idea about the measurements of the tongue movements and performed laryngeal intubation in all patients.
To define the tongue movements, horizontal lines were used. Horizontal line were passing through the mid points of mandible and upper lip height. Patients were asked to protrude tongue maximally and upward (PTMU), to protrude tongue maximally and downward (PTMD) in anatomical neutral position which was sitting down on a chair.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Undergoing abdominal surgery with general anesthesia
- Able to sit
Exclusion Criteria:
- Enable to sit,
- Patients had head or neck surgery,
- Patients with unstable cardiological and respiratory hemodynamic symptoms,
- Dental prosthesis
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Easy intubation
Intubation difficulty score <5
|
The horizontal line was passing through the mid points of the distance between subnasale to stomion (upper lip height).
Patients were asked to protrude tongue maximally and upward (PTMU).
The horizontal line was passing through the mid points of the distance between stomion to mentum (mandible height).
Patients were asked to protrude tongue maximally and downward (PTMD).
|
Aktiv komparator: Difficult intubation
Intubation difficulty score >5
|
The horizontal line was passing through the mid points of the distance between subnasale to stomion (upper lip height).
Patients were asked to protrude tongue maximally and upward (PTMU).
The horizontal line was passing through the mid points of the distance between stomion to mentum (mandible height).
Patients were asked to protrude tongue maximally and downward (PTMD).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Intubation difficulty scale
Tidsramme: 2 days
|
Intubation difficulty scale score includes 7 variables for difficult intubation.
N1: The number of attempts for intubation (for the first attempt 0 point, for the other attempts 1 point each); N2: The number of anesthesiologist for the laryngoscopies (for the first attempt 0 point, for the other attempts 1 point each); N3: Alternative intubation techniques that are used (if not needed 0 point, change of blade type or using blind nasotracheal intubation 1 point each); N4: 1 point less than Cormack and Lehane Classification for defining glottic exposure; N5: The degree of force of lifting laryngoscopy (normal lifting 0 point, more force needed 1 point); N6: Using external laryngeal pressure 1 point; N7: The view of the vocal cords (abduction position 0 point, adduction position 1 point).
A score of 0-4 defines easy intubation and an IDS score ≥5 defines difficult intubation
|
2 days
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- tongueintubation
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