- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07846748
Correlation Between Bedside Anatomical Indicators and Lifting Force and Glottic Exposure Under Different Video Laryngoscopy Techniques
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Jin
- 전화번호: +86-18235572836
- 이메일: 1806442507@qq.com
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Peak Lifting Force with Direct Epiglottis Elevation
기간: 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
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Delta POGO (ΔPOGO)
기간: Perioperative
|
Perioperative
|
|
Incidence of Difficult Glottic Exposure
기간: Perioperative
|
Perioperative
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- [2026]YX172
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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