Comparison of First Attempt Success Based on Endotracheal Tube Type During Videolaryngoscope-guided Intubation Without Stylet
28. juni 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
246
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: KYUNG WON SHIN
- Telefonnummer: 02-2072-2469
- E-mail: skwskw126@gmail.com
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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
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
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: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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 (Anslået)
1. december 2026
Primær færdiggørelse (Anslået)
17. april 2027
Studieafslutning (Anslået)
17. april 2028
Datoer for studieregistrering
Først indsendt
21. juni 2026
Først indsendt, der opfyldte QC-kriterier
28. juni 2026
Først opslået (Faktiske)
6. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2503-040-1621
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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 .