跳至主要内容
临床试验/CTRI/2026/01/102159
CTRI/2026/01/102159尚未招募不适用

Correlation between neck circumference and ultrasound guided measurement of anterior neck soft tissue thickness in predicting difficult laryngoscopy in obese patients.

Manipal Hospital1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2026年2月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
180
试验地点
1
主要终点
To find a correlation between neck

研究概览

简要总结

All patients posted for elective surgical procedures under general

anaesthesia requiring endotracheal intubation, who satisfy the

inclusion criteria and give a written informed consent will be recruited

to the study.

In the preoperative period, pre-anaesthetic assessment will be done

by the primary investigator. Height (cm), weight (kg), age (in years),

body mass index (BMI) and ASA physical status will be noted for all

patients. If they satisfy the inclusion criteria, patients will be instructed

about the study procedure and a written informed consent will be

obtained. Preoperative airway assessment will be done which will

include recording the modified Mallampati classification (MMP) [

Class I -visualisation of the hard palate, soft palate, fauces, uvula and

pillars; Class II- visualisation of the hard palate, soft palate, fauces,

and uvula; Class III- visualisation of the hard palate, soft palate, and

base of uvula; Class IV- visualisation of only the hard palate.], inter-

incisor gap (distance between upper and lower incisor) in cm,

thyromental distance (in cm), sternomental distance (in cm), and neck

circumference (in cm) at mid neck just below the laryngeal

prominence with the subject sitting and facing forward with shoulder

relaxed. All measurements will be done using a standard measuring

tape by the primary investigator who will not be involved in performing

laryngoscopy and intubation. On the day of surgery, ultrasound

measurements of the airway will be done by the primary investigator

in the preoperative room, using a linear high frequency probe (8-

13Hz), with the patient lying in supine position with head and neck in

neutral position. Anterior soft tissue thickness of the neck will be

measured at three levels, the hyoid, thyroid hyoid membrane and

anterior commissure of the vocal cord. The same measurements will

then be repeated with the patient in sniffing position.

In the operating room, ASA standard monitors will be attached,

baseline vital parameters will be recorded, the patient will be

preoxygenated and induction of anaesthesia will proceed as per

standard uniform protocol. After adequate muscle relaxation(TOF=0),

direct laryngoscopy will be performed by an experienced

anaesthesiologist (> 3 years) who is independent of the study and the

difficulty of laryngoscopy will be scored using the modified Cormack

Lehane grading with and without BURP ( backward upward rightward

pressure). A note will also be made of the number of attempts at

intubation, change in position or technique, and failed intubation. If

there are 3 failed attempts, alternate methods of securing the airway

will be pursued and the patient will no longer be included in the study.

Anaesthesia will proceed as per routine protocol and the patient will

be continuously monitored throughout the procedure.

The measured parameters will be subjected to statistical analysis to

find any correlation between them.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients scheduled for elective surgery under general endotracheal anaesthesia.
  • Age 18 years to 70 years.
  • ASA I- III patients.
  • BMI >/= 25 kg/m2.

排除标准

  • Patients with upper airway pathology, maxillofacial abnormality, cervical spine instability, trauma to the face or larynx and poor submandibular space compliance.
  • Patients posted for emergency surgeries and those requiring rapid sequence induction of anaesthesia.
  • Pregnant women and paediatric patients.
  • Inter-incisor distance < 3 cm.
  • Previous history of difficult laryngoscopy.

结局指标

主要结局

To find a correlation between neck

时间窗: 6 months

circumference and USG guided anterior neck soft tissue thickness

时间窗: 6 months

as a predictor of difficult laryngoscopy in patients with BMI /= 25

时间窗: 6 months

kg/m 2

时间窗: 6 months

次要结局

  • To measure anterior soft tissue neck thickness at the level of the(hyoid, thyrohyoid membrane & anterior commissure of vocal)

研究者

申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Gayatri Sasikumar

Manipal Hospital , Old Airport Road,Bangalore

研究点 (1)

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