Comparison of First Attempt Success Based on Endotracheal Tube Type During Videolaryngoscope-guided Intubation Without Stylet
28. juni 2026 oppdatert av: Seoul National University Hospital
Comparison of First Attempt Success Based on Endotracheal Tube Type During Videolaryngoscope-guided Intubation Without Stylet: Prospective Non-inferiority Comparison
Patients are randomly assigned to either the oral RAE tube group (Group O) or the reinforced tube group (Group R).
In both groups, tracheal intubation is performed using a videolaryngoscope without a stylet, and the first-attempt success rate is compared.
Upon emergence from anesthesia and removal of the endotracheal tube, the degree of subglottic injury is assessed and compared between the groups.
In addition, postoperative sore throat and hoarseness are evaluated and compared at 1 hour and 24 hours after surgery.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
246
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: KYUNG WON SHIN
- Telefonnummer: 02-2072-2469
- E-post: skwskw126@gmail.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Adults aged 19 years or older
- Scheduled to undergo surgery under general anesthesia
Exclusion Criteria:
- Refusal to participate in the study
- History of gastroesophageal reflux disease
- Inadequate preoperative fasting
- Congenital or acquired upper airway abnormalities (e.g., tumors, polyps, trauma, abscesses, inflammation, foreign bodies)
- History of upper airway surgery
- High risk of aspiration or bleeding tendency
- Presence of severely loose teeth
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: oral RAE tube group
|
Tracheal intubation is performed using a videolaryngoscope without a stylet.
In Group O, an oral RAE tube is used, while in Group R, a reinforced endotracheal tube is used.
Intubation is conducted after induction of general anesthesia.
Upon completion of surgery, the endotracheal tube is removed, and the degree of subglottic injury is assessed.
Postoperative sore throat and hoarseness are evaluated at 1 hour and 24 hours after extubation.
|
|
Aktiv komparator: reinforced tube group
|
Tracheal intubation is performed using a videolaryngoscope without a stylet.
In Group O, an oral RAE tube is used, while in Group R, a reinforced endotracheal tube is used.
Intubation is conducted after induction of general anesthesia.
Upon completion of surgery, the endotracheal tube is removed, and the degree of subglottic injury is assessed.
Postoperative sore throat and hoarseness are evaluated at 1 hour and 24 hours after extubation.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
First-attempt success rate of tracheal intubation
Tidsramme: Immediately after induction of anesthesia
|
The proportion of patients in whom tracheal intubation is successfully completed on the first attempt using a videolaryngoscope without a stylet, comparing the oral RAE tube group with the reinforced tube group.
|
Immediately after induction of anesthesia
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence and grade of subglottic airway injury
Tidsramme: Immediately after completion of surgery (at extubation)
|
Assessed using flexible bronchoscopy at the time of extubation; graded on a 0-3 scale
|
Immediately after completion of surgery (at extubation)
|
|
Postoperative sore throat score
Tidsramme: 1 hour and 24 hours postoperatively
|
Sore throat severity assessed using the Numeric Rating Scale (NRS, 0-10) at 1 and 24 hours after surgery.
|
1 hour and 24 hours postoperatively
|
|
Incidence of postoperative hoarseness
Tidsramme: 1 hour and 24 hours postoperatively
|
Binary evaluation (presence or absence) of hoarseness at 1 and 24 hours after surgery.
|
1 hour and 24 hours postoperatively
|
|
Cormack-Lehane grade and POGO score
Tidsramme: Periprocedural (during tracheal intubation)
|
Airway visualisation was assessed during tracheal intubation using the Cormack-Lehane grading system (Grade I-IV, where Grade I indicates full view of the glottis and Grade IV indicates no visible glottic structures; lower grades indicate better glottic visualisation) and the Percentage of Glottic Opening (POGO) score (0-100%, where higher scores indicate better glottic visualisation).
|
Periprocedural (during tracheal intubation)
|
|
Mean blood pressure
Tidsramme: Periprocedural (immediately before and immediately after tracheal intubation)
|
Periprocedural (immediately before and immediately after tracheal intubation)
|
|
|
Heart rate
Tidsramme: Periprocedural (immediately before and immediately after tracheal intubation)
|
Periprocedural (immediately before and immediately after tracheal intubation)
|
|
|
Oxygen saturation
Tidsramme: Periprocedural (immediately before and immediately after tracheal intubation)
|
Periprocedural (immediately before and immediately after tracheal intubation)
|
|
|
Bispectral index
Tidsramme: Periprocedural (immediately before and immediately after tracheal intubation)
|
Periprocedural (immediately before and immediately after tracheal intubation)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. desember 2026
Primær fullføring (Antatt)
17. april 2027
Studiet fullført (Antatt)
17. april 2028
Datoer for studieregistrering
Først innsendt
21. juni 2026
Først innsendt som oppfylte QC-kriteriene
28. juni 2026
Først lagt ut (Faktiske)
6. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2503-040-1621
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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