- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07642206
Combined Ultrasound and Upper Lip Bite Test Assessment of Difficult Laryngoscopy in Obese Patients
Ultrasound-Measured Hyomental Distance Ratio Combined With the Upper Lip Bite Test as a Predictor of Difficult Laryngoscopy in Obese Patients: A Prospective Observational Study
The aim of this observational study is to evaluate the accuracy of the HMDR combined with the ULBT as a predictor of difficult laryngoscopy in obese patients undergoing elective surgery under general anesthesia, regarding:
- Correlation of HMDR-ULBT values with Cormack-Lehane grades during laryngoscopy.
- Comparison of HMDR-ULBT with standard HMDR in predicting difficult laryngoscopy.
연구 개요
상태
정황
상세 설명
Airway management is a cornerstone of safe anesthesia practice. Difficult laryngoscopy and intubation remain a critical challenge for anesthesiologists. The ability to predict difficult airway situations preoperatively remains crucial, particularly in high-risk populations such as obese patients. These patients have significantly higher rates of difficult mask ventilation and tracheal intubation.
Numerous bedside screening tests have been established to predict difficult laryngoscopy, including the Mallampati classification, thyromental distance, the upper lip bite test (ULBT), and hyomental distance (HMD) measurements. However, none of these tests alone possesses sufficient sensitivity or specificity, and their predictive performance in obese individuals remains variable .
The Hyomental Distance Ratio (HMDR), defined as the ratio of the hyomental distance in maximal head extension to that in the neutral position , is a dynamic parameter reflecting upper airway compliance and anatomical displacement. An HMDR value <1.2 has been associated with increased risk of difficult laryngoscopy in several studies . Traditionally, the HMDR is measured either manually with a ruler or more objectively using ultrasound.
The Upper Lip Bite Test (ULBT) is a simple, validated bedside test assessing mandibular protrusion and temporomandibular joint mobility, two key factors influencing the success of glottic visualization . The ULBT is performed in a conscious state, making it a practical tool in airway assessment.
Given that the ULBT involves active mandibular protrusion, it may mimic the anterior displacement of airway structures achieved during head extension or jaw thrust. Therefore, measuring the hyomental distance while the patient performs the ULBT could serve as a novel dynamic modification of the traditional HMDR-potentially offering a more functional and patient-cooperative measure.
Recent studies have validated the HMDR (extension/neutral) as a useful predictor of difficult laryngoscopy by ultrasound, due to its capacity to evaluate the anterior neck space and upper airway alignment . However, these studies primarily assess neck extension without incorporating mandibular movement, despite its key role in airway visualization. To date, no published studies have evaluated the hyomental distance combined with the ULBT using ultrasound or compared it with the traditional HMDR, leaving an interesting gap in the literature.
Combining the anatomical advantages of anterior neck space assessment with functional jaw mobility via the HMDR combined with the ULBT may yield a more comprehensive and accurate predictor of difficult airway, especially in obese or anatomically challenging patients. This novel approach may detect subtle impairments in upper airway dynamics not captured by the static HMDR alone. To our knowledge, this application has not yet been explored in existing literature.
This study, therefore, aims to evaluate the accuracy of the HMDR combined with the ULBT as a predictor of difficult laryngoscopy in obese patients undergoing elective surgery under general anesthesia, using difficult laryngoscopy-defined as Cormack-Lehane grade 3 or 4-as the primary outcome .
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Makarious Morris Aboelkheir, MSc
- 전화번호: +201225246321
- 이메일: makariousmorris0@gmail.com
연구 연락처 백업
- 이름: Yasmin Khaled Ahmed, MD
- 전화번호: +201095015566
- 이메일: dr_ykh@hotmail.com
연구 장소
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, 이집트
- Kasr Al-Ainy Hospital, Cairo University
-
연락하다:
- Makarious Morris Aboelkheir, MSc
- 전화번호: +201225246321
- 이메일: makariousmorris0@gmail.com
-
연락하다:
- Yasmin Khalid Ahmed, MD
- 전화번호: +201095015566
- 이메일: dr_ykh@hotmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adult obese patients aged 18 to 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status II- III.
- Body Mass Index (BMI) ≥ 30 kg/m² (classified as obese).
- Scheduled for elective surgical procedures requiring general anesthesia with endotracheal intubation.
- Ability to understand and provide informed written consent.
- Cooperative and able to perform the ULBT on command.
- Normal dentition (presence of upper and lower incisors to perform ULBT accurately).
Exclusion Criteria:
- History of maxillofacial trauma, surgery, or congenital facial anomalies affecting mandibular movement or neck anatomy.
- Known or suspected difficult airway requiring awake intubation.
- Patients with limited neck mobility (e.g., cervical spine disease or immobilization).
- Temporomandibular joint disorders or restricted mandibular mobility.
- Pregnancy.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: HMD measured by US in neutral head position , maximum head extension and during upper lip bite test
Hyomental distance will be measured using ultrasound in three positions: neutral head position, maximum head extension, and during the upper lip bite test (ULBT).
|
Hyomental distance will be measured using ultrasound in three positions: neutral head position, maximum head extension, and during the upper lip bite test (ULBT).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Prediction of difficult laryngoscopic view, defined as Cormack-Lehane Grade 3 or 4 on the first laryngoscopy attempt without external laryngeal manipulation.
기간: Day of surgery from preoperative assessment to first laryngoscopy attempt after induction of general anethesia and after three minutes of mask ventilation.
|
Difficult laryngoscopic view is defined as Cormack-Lehane Grade III or IV during the first laryngoscopy attempt without external laryngeal manipulation Cormack-Lehane classification for laryngoscopic view : grade 1: most of the vocal cords is seen; grade 2: only the posterior part of the vocal cords or the arytenoid cartilages are seen; grade 3: only epiglottis is seen; grade 4: epiglottis is not seen. |
Day of surgery from preoperative assessment to first laryngoscopy attempt after induction of general anethesia and after three minutes of mask ventilation.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Determination of an optimal cutoff value for HMDR-ULBT to predict difficult laryngoscopy.
기간: From preoperative airway assessment until completion of the first laryngoscopy attempt during induction of anesthesia on the day of surgery
|
Receiver operating characteristic (ROC) curve analysis will be performed to determine the optimal cutoff value of the hyomental distance ratio measured during the upper lip bite test (HMDR-ULBT) for predicting difficult laryngoscopic view, defined as Cormack-Lehane Grade III or IV on the first laryngoscopy attempt without external laryngeal manipulation.
The area under the ROC curve (AUC), sensitivity, specificity, positive predictive value, and negative predictive value corresponding to the optimal cutoff value will be calculated.
|
From preoperative airway assessment until completion of the first laryngoscopy attempt during induction of anesthesia on the day of surgery
|
|
Comparison of HMDR-ULBT with standard HMDR in predicting difficult laryngoscopy.
기간: From preoperative airway assessment until completion of the first laryngoscopy attempt during induction of anesthesia.
|
The predictive performance of the hyomental distance ratio measured during the upper lip bite test (HMDR-ULBT) will be compared with that of the standard hyomental distance ratio (HMDR) for predicting difficult laryngoscopic view, defined as Cormack-Lehane Grade III or IV during the first laryngoscopy attempt without external laryngeal manipulation.
Diagnostic accuracy parameters, including sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic (ROC) curve, will be compared between the two methods.
|
From preoperative airway assessment until completion of the first laryngoscopy attempt during induction of anesthesia.
|
공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
일반 간행물
- Bhanushali A, Date A. Evaluation of upper lip bite test and thyromental height test for prediction of difficult laryngoscopy: A prospective observational study. Airway. 2021;4(3):621-42.
- Hrithma D, K R, Mahadevaiah DT, K N V. A Cross-Sectional Study on Hyomental Distance Ratio (HMDR) as a New Predictor of Difficult Laryngoscopy in ICU Patients. Cureus. 2022 May 28;14(5):e25435. doi: 10.7759/cureus.25435. eCollection 2022 May.
- Liaskou C, Vouzounerakis E, Trikoupi A, Staikou C. [Evaluation of bedside tests and proposal of a model for predicting difficult laryngoscopy: an observational prospective study]. Braz J Anesthesiol. 2020 Mar-Apr;70(2):125-133. doi: 10.1016/j.bjan.2020.02.007. Epub 2020 May 13.
- Liu Y, He Y, Wang X, Li J, Zhang Z, Zhuang X, et al. Advances in airway management in recent 10 years from 2013 to 2023. Anesthesiol Perioper Sci. 2023;1(4):27-30.
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
- Airway Ultrasound
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
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .