跳至主要内容
临床试验/CTRI/2024/12/078532
CTRI/2024/12/078532已完成不适用

A prospective study to compare intubation prediction score versus Wilsons score for the prediction of difficult endotracheal intubation

Smt. Bhikhiben Kanjibhai Shah Medical Institute and Research Centre1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年1月6日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
To assess the sensitivity, specificity, positive predictive value and accuracy of intubation prediction score versus Wilsons score for predicting difficult endotracheal intubation

研究概览

简要总结

Introduction

Prediction of difficult airway is of utmost importance to anaesthesiologist in the operating room as an unanticipated difficult airway leads to severe adverse events. Prediction of difficult airway is clinically done by independent bedside tests but lack accuracy. Moreover, most airway assessment scores are cumbersome to perform at the bedside and have interobserver variability because of subjective parameters. Therefore, there is a need to search for a simple score with objective parameters that can be performed at the bedside. 

Aim:

To determine the diagnostic accuracy of the Wilson score and Intubation prediction score for predicting difficult airway.

Materials and Method:

A prospective single-blind study will be conducted involving 120 consecutive patients aged 18 to 60 years who are undergoing surgery requiring general anaesthesia with endotracheal intubation. All patients will have their airways evaluated preoperatively using the Wilson Score and Intubation Prediction Score. General anaesthesia with endotracheal intubation will be performed on all participants. The ease of laryngoscopy and intubation will be assessed using the Intubation Difficulty Scale, where an IDS score greater than 5 indicates a difficult airway. In this study we will calculate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of the two predictive tests for identifying a difficult airway.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients willing to sign informed consent.
  • Patients between ages of 18 to 60 years.
  • Patients posted for elective surgeries under general anaesthesia requiring endotracheal intubation.

排除标准

  • Patients unwilling to participate in the study.
  • Patients with previous history of trauma to airway.
  • Patients undergoing emergency surgery.
  • Patients having tumors or mass in the laryngeal, facial and cervical region or any other gross abnormalities of head and neck region.
  • Patients having any cervical spine pathology.

结局指标

主要结局

To assess the sensitivity, specificity, positive predictive value and accuracy of intubation prediction score versus Wilsons score for predicting difficult endotracheal intubation

时间窗: Assessment of parameters as per Wilsons score and intubation prediction score pre operatively in all patients for predicting difficult endotracheal intubation

次要结局

  • Relatively more accurate prediction of difficult intubation and avoidance of unanticipated difficult airway(Assessment of parameters as per Wilsons score and intubation prediction score pre operatively in all patients for predicting difficult endotracheal intubation)

研究者

发起方
Smt. Bhikhiben Kanjibhai Shah Medical Institute and Research Centre
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Apoorva Tarafdar

Smt. Bhikhiben Kanjibhai Shah Medical Institute and Research Centre

研究点 (1)

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