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Correlation Between Bedside Anatomical Indicators and Lifting Force and Glottic Exposure Under Different Video Laryngoscopy Techniques

22. september 2026 opdateret af: Zheng Guo, Second Hospital of Shanxi Medical University

This single-center prospective observational study plans to enroll 196 patients undergoing elective general anesthesia. The study aims to investigate the correlation between preoperative bedside anatomical indicators (including modified Mallampati classification, upper lip bite test, mouth opening, head circumference, and thyromental distance) and the peak lifting force applied during video laryngoscopy, as well as the degree of glottic exposure (POGO score). The study will also evaluate the potential benefit of the direct epiglottis elevation technique in specific anatomical subgroups. After anesthesia induction, the same anesthesiologist will perform video laryngoscopy using two distinct techniques in a fixed sequence: the indirect (vallecula) method and the direct (subepiglottic) method. Peak lifting force will be quantitatively measured in real-time using a resistive thin-film pressure sensor attached to the laryngoscope blade. The primary outcomes are the POGO scores and peak lifting forces under both techniques. The secondary outcome includes the change in POGO score (ΔPOGO) between techniques. The study will provide quantitative evidence regarding the "anatomy-force-view" relationship and aid in individualized clinical decision-making for video laryngoscopy intubation.

Studieoversigt

Status

Ikke rekrutterer endnu

Detaljeret beskrivelse

This study is a single-center, prospective, observational study. A total of 196 adult patients scheduled for elective surgery under general anesthesia requiring orotracheal intubation will be enrolled. Preoperative bedside anatomical assessment will be performed by a standardized, blinded evaluator. The assessed indicators include mouth opening, thyromental distance, modified Mallampati classification, upper lip bite test, head circumference, and neck circumference. After standard anesthesia induction, video laryngoscopy will be performed by an experienced anesthesiologist. Two techniques will be evaluated in a fixed sequence: (1) Indirect epiglottis elevation (vallecula method): the blade tip is placed in the vallecula to indirectly elevate the epiglottis by lifting the tongue base. (2) Direct epiglottis elevation (subepiglottic method): the blade tip is advanced past the vallecula and placed directly under the laryngeal surface of the epiglottis to actively lift it. A resistive thin-film pressure sensor attached to the video laryngoscope blade will continuously record real-time force data, and the peak lifting force will be extracted for analysis. Glottic exposure will be evaluated using the Percentage of Glottic Opening (POGO) score. Between the two assessments, mask ventilation will be performed for at least 2 minutes to maintain SpO2 ≥ 98%. All procedures and data collection will adhere to the approved protocol by the Ethics Committee of the Second Hospital of Shanxi Medical University (Approval No. [2026] YX No. 172). Statistical analyses will be performed using SPSS 26.0 and R software, including Spearman rank correlation, Kruskal-Wallis test, and multiple linear regression with Bootstrap validation.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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 til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adult patients aged 18 to 75 years with ASA physical status I to III who are scheduled for elective surgery under general anesthesia requiring orotracheal intubation under video laryngoscopy guidance. Patients with known difficult airway, facial or neck abnormalities affecting landmark palpation, limited mouth opening (< 2.0 cm), or edentulism are excluded.

Beskrivelse

Inclusion Criteria:

  • - Age 18 to 75 years
  • ASA physical status I to III
  • Scheduled for orotracheal intubation under video laryngoscopy guidance
  • Written informed consent obtained

Exclusion Criteria:

  • Known history of difficult airway or anticipated need for awake intubation

    • Facial or neck trauma, burns, or surgical history affecting palpation of anatomical landmarks
    • Temporomandibular joint ankylosis or mouth opening < 2.0 cm
    • Edentulous patients

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Patients Undergoing Video Laryngoscopy

Adult patients scheduled for elective general anesthesia requiring orotracheal intubation under video laryngoscopy guidance. All participants will undergo both indirect and direct epiglottis elevation techniques in a fixed sequence.

Video laryngoscopy blade tip advanced past the vallecula and placed under the laryngeal surface of the epiglottis to directly lift it.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Peak Lifting Force with Direct Epiglottis Elevation
Tidsramme: Perioperative

Peak lifting force (gf) measured by a resistive thin-film pressure sensor attached to the video laryngoscope blade during the direct (subepiglottic) technique.

Perioperative
Peak Lifting Force with Indirect Epiglottis Elevation
Tidsramme: Perioperative

Peak lifting force (gf) measured by a resistive thin-film pressure sensor attached to the video laryngoscope blade during the indirect (vallecula) technique.

Perioperative
POGO Score with Indirect Epiglottis Elevation
Tidsramme: Perioperative

Percentage of Glottic Opening (POGO) score assessed via video laryngoscopy using the indirect (vallecula) technique. The scale ranges from 0% to 100%, where higher scores indicate better visualization of the glottis (better outcome).

Perioperative
POGO Score with Direct Epiglottis Elevation
Tidsramme: Perioperative

Percentage of Glottic Opening (POGO) score assessed via video laryngoscopy using the direct (subepiglottic) technique. The scale ranges from 0% to 100%, where higher scores indicate better visualization of the glottis (better outcome).

Perioperative

Sekundære resultatmål

Resultatmål
Tidsramme
Delta POGO (ΔPOGO)
Tidsramme: Perioperative
Perioperative
Incidence of Difficult Glottic Exposure
Tidsramme: Perioperative
Perioperative

Samarbejdspartnere og efterforskere

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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. oktober 2026

Primær færdiggørelse (Anslået)

1. april 2027

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

16. september 2026

Først indsendt, der opfyldte QC-kriterier

22. september 2026

Først opslået (Faktiske)

29. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • [2026]YX172

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