- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07668297
Correlation of Neck Dimensions of Airway Evaluation
Correlation of Thyromental Distance And Mandibular Triangle Perpendicular Length With Incisor Vallecular Distance In Adult Pre-Surgical Patients: An Observational Study
연구 개요
상세 설명
Preoperative evaluation of the upper airway is vital to the success, safety, and quality of airway access. The evaluation primarily aims to anticipate the course of direct laryngoscopy and intubation (DLI) of the trachea. While assessment of mouth opening, neck extension, and dentition forms the preliminary step of knowing whether DLI is feasible; there are certain other parameters whose evaluation facilitates understanding as to how the actual DLI will turn out. Among the secondary parameters, the linear thyromental distance (TMD) is an important measure that determines how the direct laryngoscopy aspect of conducting DLI will go - in terms of ease-of-laryngoscopy to gain the desired visual access to the view to the vocal cords. The ease of laryngoscopy involves as to how the laryngoscope blade would be able to displace tongue to one side, create forward space enhancement, and reach the vallecula at the base of the tongue; before lifting the epiglottis to view the cords. Though in use for over 4 decades, the TMD suffers from weakness, including, low sensitivity and specificity, not relating to the actual and direct teeth vallecular distance, and getting confounded by neck dimensions (thickness, length), state of dentition, and the tongue size.
The present study is built on the premise that it's the mandibular space to which the tongue is displaced at the time of DLI, the bony mandibular space is more exclusive of the confounders, and that the teeth (lower incisors) vallecular distance represent the actual distance that needs to be predicted.
The present study aims to evaluate TMD and mandibular triangle perpendicular length (MTPL); to know which correlates better with the incisor vallecula distance (IVD). Based on the direction and strength of the correlation measure, a multiple regression equation can then be created to first predict the IVD with external linear measure, and second, based on IVD length prediction, the appropriate laryngoscope blade size can be ascertained.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Amitabh Dutta, MD
- 전화번호: 00919810848064
- 이메일: duttaamitabh@yahoo.co.in
연구 장소
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National Capital Territory of Delhi
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New Delhi, National Capital Territory of Delhi, 인도, 110060
- 모병
- Sir Ganga Ram Hospital
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연락하다:
- Amitabh Dutta, MBBS, MD, PGDHR
- 전화번호: 9810848064
- 이메일: duttaamitabh@yahoo.co.in
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age 18-65 years
- Males and females
- ASA (American Society of Anaesthesiologists) physical status I and II
- Patients scheduled for elective surgery with controlled ventilation through orotracheal tube conduit
Exclusion Criteria:
- Smokers (those who have smoked ≥100 cigarettes in their lifetime), chewing tobacco dependence or substance abuse
- Submucous fibrosis: progressive fibrosis of the submucosal tissue leading to rigidity, relative trismus, and progressive decrease of mouth opening
- Anticipated difficult airway
- Patients requiring intubation with MacIntosh blade #4 or #5
Dental issues:
- missing tooth (upper/lower incisors, upper/lower premolar)
- crowded dentition: - irregular, misaligned, or overlapping teeth within a relatively small oral cavity
presence of artificial teeth and/or dental implants
• Mandible/mandibular structure related issues:
- Retrognathia: - posterior displacement of the mandible relative to the maxilla or cranial base
- Prognathia: - anterior displacement of the mandible relative to the maxilla or cranial base
- Emergency Surgery
- Those requiring urgent rapid-sequence intubation due to the presence of a full-stomach status secondary to gastro-esophageal reflux disease, diaphragmatic hernia, among others.
- Refusal to informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Correlation of thyromental distance (TMD) and mandibular triangle perpendicular length (MTPL) with incisor vallecular distance (IVD)
기간: From entry into preoperative area (0 minutes) to time patient is shifted to operating room ( 10-minutes)
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In all patients thyromental distance (TMD) and mandibular triangle perpendicular length (MTPL) will be measured.
TMD will be measured as a straight line distance between the bony mentum (tip of the chin) and the superior thyroid notch (upper border of the thyroid cartilage).
MTPL will be measured as the perpendicular of the mandibular triangle formed by joining the mental protuberence and point at angle of mandible on either side.
During direct larygngosocpoy when the tip of the laryngoscope blade lies on the vallecula, the distance between the laryngoscope blade tip and the point of laryngoscope blade flange overlying the lower incisors will be measured.
A correlation between TMD and MTPL with IVD if any will be established.
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From entry into preoperative area (0 minutes) to time patient is shifted to operating room ( 10-minutes)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Correlation of incisor vallecular distance (IVD), mandibular triangle perpendicular length (MTPL), and thyromental distance (TMD) with Macintosh blade (MCB) size#3 length
기간: From induction of anaesthesia (0 minutes) to insertion of endotracheal tube ( 10-minutes)
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Macintosh blade size # 3 length will be determined by measuring the linear distance between the tip of the blade and the point where the concave surface of the blade flange joins the heel of the the laryngoscope blade.
A correlation between IVD, MTPL, and TMD with Macintosh blade size # 3 length if any will be established
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From induction of anaesthesia (0 minutes) to insertion of endotracheal tube ( 10-minutes)
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Cormack and Lehane score
기간: From induction of anaesthesia (0 minutes) to insertion of endotracheal tube ( 10-minutes)
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The grade view to the glottic-opening upon direct laryngoscopy will be done using the 4-point Cormack-Lehane grading system (grade 1: entire glottic opening is seen; grade 2: anterior larynx not visualised, only posterior laryngeal aperture is seen; grade 3: only tip of epiglottis is seen; grade 4: neither glottis or epiglottis is visible, only soft palate is seen)
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From induction of anaesthesia (0 minutes) to insertion of endotracheal tube ( 10-minutes)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Amitabh Dutta, MD, Sir Ganga Ram Hospital, New Delhi-110060, India
- 수석 연구원: Paridhi Saboo, MBBS, Sir Ganga Ram Hospital, New Delhi-110060, India
- 연구 책임자: Nitin Sethi, DNB, Sir Ganga Ram Hospital, New Delhi-110060, India
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
- EC/06/26/2981
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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