跳至主要内容
临床试验/CTRI/2025/03/082090
CTRI/2025/03/082090招募中不适用

Effect of sniffing position versus left head rotation (LeHeR) manoeuvre on glottic visualisation during videolaryngoscopy in patients undergoing elective surgery under general endotracheal anaesthesia- A prospective randomised cross-over study

未提供1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2025年11月7日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
192
试验地点
1
主要终点
To compare the effect POGO score during sequential video laryngoscopy with conventional sniffing position versus left head rotation (LeHeR) technique in the same patient.

研究概览

简要总结

This thesis aims to compare the effects of the conventional sniffing position versus the left head rotation (LeHeR) manoeuvre on glottic visualization during videolaryngoscopy in patients undergoing elective surgery under general endotracheal anesthesia. The primary objective is to assess and compare the percentage of glottic opening (POGO) score between the two techniques in the same patient, while the secondary objective is to calculate the proportion of patients requiring optimal external laryngeal manipulation (OELM) to achieve a POGO score of at least 50% in each technique.

This will be a randomized, crossover study conducted over 18 months at the Department of Anaesthesia, All India Institute of Medical Sciences (AIIMS), Bathinda, Punjab. The study will involve adult patients aged 18 to 65 years, with a BMI between 18.5 and 35 kg/m², and American Society of Anaesthesiologists (ASA) physical status class I or II, who are undergoing elective surgical procedures requiring general endotracheal intubation. Patients with a variety of exclusion criteria, including significant airway or neck abnormalities, will not be included in the study. The sample size was calculated based on a non-inferiority design, with 192 patients included to account for a 10% dropout rate.

Participants will be randomly assigned to one of two groups using a computer-generated randomization sequence, with each patient undergoing both techniques in a crossover manner, ensuring a washout period between the two procedures to minimize bias. Both techniques will be performed following standard anesthetic induction, which includes the administration of midazolam, lignocaine, propofol, fentanyl, and vecuronium, with pre-oxygenation prior to videolaryngoscopy. In the sniffing position, the patient will be placed in the supine position with a pillow under the occiput to flex the neck and extend the head, while in the LeHeR technique, the patient’s head will be rotated to the left by 45°.

During each laryngoscopy sequence, the POGO score will be recorded, and if the score is less than 50%, optimal external laryngeal manipulation will be applied, with improvements in the POGO score noted. After completing both sequences, endotracheal intubation will be performed, and anesthesia will be maintained with titrated doses of propofol to maintain a Bispectral Index (BIS) between 40 and 60. Data will be collected on the POGO scores and the need for OELM, and analyzed using statistical software (SPSS, version 29) to compare the outcomes of the two techniques.

The results of this study will contribute to a better understanding of how different head positioning techniques affect glottic visualization during videolaryngoscopy and could have implications for improving airway management in clinical practice.

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研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • BMI range of 18.5 to
  • ASA grade I and II Mallampati grade I,II and III.

排除标准

  • Parturient Thyromental distance less than six centimetres Mouth opening less than three finger breadths Limited head rotation Mid-facial anomalies Neck anomalies, cervical spine pathology Facial fractures obstructing the airway Known gastroesophageal reflux Patients with a known history of coronary artery disease Patients who are not willing to participate.

结局指标

主要结局

To compare the effect POGO score during sequential video laryngoscopy with conventional sniffing position versus left head rotation (LeHeR) technique in the same patient.

时间窗: Intraoperatively

次要结局

  • To calculate the proportion of patients in each sequence in whom optimal external laryngeal manoeuvre (OELM) was needed in order to obtain a POGO score of at least 50%(Intraoperatively)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Shivani Tomar

AIIMS Bathinda

研究点 (1)

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