- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07694154
Ultrasonographic Airway Assessment and VIDIAC Score
Evaluation of the Relationship Between Ultrasonographic Airway Measurements, Videolaryngoscopic Intubation Findings, and the Video Intubation Difficulty Assessment Classification (VIDIAC) Score in Adult Patients: A Prospective Observational Study
Studieoversigt
Status
Detaljeret beskrivelse
Difficult airway management is a major cause of anesthesia-related morbidity and mortality. Airway ultrasonography has emerged as a noninvasive tool for evaluating airway anatomy and may help predict difficult intubation. The Video-Intubation Difficulty Assessment Classification (VIDIAC) score is a recently developed and standardized method for assessing videolaryngoscopic intubation difficulty.
This prospective, observational, single-center study aims to evaluate the relationship between preoperative ultrasonographic airway measurements and the VIDIAC score in adult patients undergoing elective surgery under general anesthesia. Ultrasonographic measurements, including tongue depth, tongue thickness, hyomental distance, hyoid depth, hyoid width, and distance from skin to epiglottis, will be obtained before anesthesia induction.
Videolaryngoscopic intubation will be performed by anesthesiologists blinded to the ultrasound findings, and the VIDIAC score will be recorded. The study will assess the correlation between ultrasonographic airway measurements and the VIDIAC score, as well as the ability of these measurements to predict difficult videolaryngoscopic intubation.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Betül Çiftçi Kurt
- Telefonnummer: 5301785995
- E-mail: betulciftcikurt@gmail.com
Undersøgelse Kontakt Backup
- Navn: Hatice Selçuk Kuşderci
- Telefonnummer: 0 505 215 98 96
- E-mail: drkusderci@hotmail.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Adults aged 18 to 80 years.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Patients scheduled for endotracheal intubation under general anesthesia.
- Patients who provide written informed consent.
Exclusion Criteria:
- Known airway abnormalities.
- Head and neck tumors.
- Patients with a tracheostomy.
- Pregnant patients.
- Emergency surgical procedures.
- Patients with limited cervical mobility.
- Patients with facial trauma.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To evaluate the relationship between preoperative ultrasonographic airway measurements and the VIDIAC score.
Tidsramme: During videolaryngoscopic intubation
|
Assessment of the correlation between preoperative ultrasonographic airway measurements and the VIDIAC score in adult patients undergoing videolaryngoscopic intubation.
|
During videolaryngoscopic intubation
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Difficult Videolaryngoscopic Intubation
Tidsramme: During videolaryngoscopic intubation
|
The incidence of difficult videolaryngoscopic intubation will be recorded and analyzed according to the VIDIAC score.
Patients meeting the predefined criteria for difficult videolaryngoscopic intubation will be identified, and the frequency of difficult intubation will be calculated.
|
During videolaryngoscopic intubation
|
|
Cormack-Lehane Grade
Tidsramme: During videolaryngoscopic intubation
|
The Cormack-Lehane grade obtained during videolaryngoscopic intubation will be recorded and analyzed to evaluate its relationship with preoperative ultrasonographic airway measurements and the VIDIAC score.
|
During videolaryngoscopic intubation
|
|
Intubation Time
Tidsramme: During videolaryngoscopic intubation
|
The duration of videolaryngoscopic intubation, measured from insertion of the videolaryngoscope into the oral cavity until successful placement of the endotracheal tube.
|
During videolaryngoscopic intubation
|
|
First-Attempt Intubation Success Rate
Tidsramme: During videolaryngoscopic intubation
|
The proportion of patients successfully intubated on the first videolaryngoscopic attempt without the need for additional intubation attempts.
|
During videolaryngoscopic intubation
|
|
Requirement for Additional Airway Maneuvers
Tidsramme: During videolaryngoscopic intubation
|
The need for additional airway maneuvers during videolaryngoscopic intubation, including external laryngeal manipulation, repositioning, use of a bougie, stylet adjustment, or other adjunctive techniques to facilitate successful intubation.
|
During videolaryngoscopic intubation
|
|
Occurrence of Oxygen Desaturation
Tidsramme: During videolaryngoscopic intubation
|
The occurrence of oxygen desaturation during videolaryngoscopic intubation, defined as a decrease in peripheral oxygen saturation (SpO₂) below 90%.
|
During videolaryngoscopic intubation
|
|
Number of Intubation Attempts
Tidsramme: During videolaryngoscopic intubation
|
The total number of videolaryngoscopic intubation attempts required to achieve successful endotracheal intubation.
An intubation attempt is defined as insertion of the videolaryngoscope into the oral cavity with the intention of placing the endotracheal tube.
|
During videolaryngoscopic intubation
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- GOKAEK 2026/11/19
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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