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临床试验/NCT04439487
NCT04439487Unknown不适用

Thyromental Height Test as a New Method for Prediction of Difficult Intubation in Obese Patients

Medical University of Silesia2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
2
主要终点
Thyromental height (TMH). [mm]

研究概览

简要总结

The main objective of this trial is to assess the clinical usefulness of thyromental height test (TMHT) in prediction of difficult intubation in obese patients scheduled for elective surgical procedures. The secondary aim is to evaluate usefulness of other commonly used predictive tests associated with difficult intubation in obese patients.

详细描述

Successful and fast intubation are crucial for the safety of general anaesthesia. Failed intubation and acute hypoxia remain among the major contributing factors of anaesthesia related deaths. Difficult intubation prevalence in literature is very inconsistent and varies between 1.5-20% of cases in general population, to even 50% in obese Thai population.

Obesity remains a challenging problem in perioperative care. It is assumed that the airway access may be restricted due to anatomic changes resulting from excess body weight. There are factors like diagnosed obstructive sleep apnoea or large neck circumference that also relate to occurrence of difficult intubation in obese patients.

There is a number of anthropometric scales and tests used for predicting difficult intubation in obese patients. However, none of them appears to be sensitive and specific enough to effectively predict difficult intubation.

Recently, simple and non-invasive test predicting difficult intubation was introduced-thyromental height test (TMHT). It shows promise as a more effective substitution for frequently cited anthropometric measures. It is based on the height between the anterior border of the thyroid cartilage and the anterior border of the mentum, measured while the patient lies in the supine position with closed mouth.

The main objective of this trial is to assess the clinical usefulness of TMHT in prediction of difficult intubation in obese patients scheduled for elective surgical procedures. The secondary aim is to evaluate usefulness of other commonly used predictive tests associated with difficult intubation in obese patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • qualification for elective surgical procedures, requiring general anaesthesia, direct laryngoscopy and intubation
  • consent for participation in the trail
  • age ≥18 years
  • BMI ≥30 kg/m2

排除标准

  • BMI ≤30 kg/m2
  • patients overweight due to ascites or tumor
  • emergency procedures
  • visible anatomic abnormalities
  • patients scheduled for awake fibreoptic intubation
  • intubation failure
  • lack of consent for participation in the trail

结局指标

主要结局

Thyromental height (TMH). [mm]

时间窗: Preoperatively (an average of 24 hours)

Thyromental height is defined as the height between the anterior border of the thyroid cartilage (on the thyroid notch just between the 2 thyroid laminae) and the anterior border of the mentum (on the mental protuberance of the mandible). It is measured with a depth gauge during routine preoperative anaesthetic visit in supine position and closed mouth.

Score in Cormack-Lehane scale (CL).

时间窗: Intraoperatively (an average of 5 minutes)

During direct laryngoscopy after the induction of general anesthesia the laryngeal view is graded in Cormack-Lehane Scale by the laryngoscopist. Grade I is assigned when the glottis is fully visible, grade II when the glottis is partially visible, grade III when only the epiglottis is visible and grade IV when neither glottis nor epiglottis is visible.

次要结局

  • Thyromental distance (TMD). [cm](Preoperatively (an average of 24 hours))
  • Intubation time. [s](Intraoperatively (an average of 5 minutes))
  • Sternomental distance (SMD). [cm](Preoperatively (an average of 24 hours))
  • Neck circumference (NC). [cm](Preoperatively (an average of 24 hours))
  • Mouth opening (MO). [cm](Preoperatively (an average of 24 hours))
  • Number of intubation attempts.(Intraoperatively (an average of 5 minutes))
  • Use of bougie.(Intraoperatively (an average of 5 minutes))
  • Intubation difficulty.(Intraoperatively (an average of 5 minutes))
  • Score in modified Mallampati test (MMT).(Preoperatively (an average of 24 hours))
  • Technique modification.(Intraoperatively (an average of 5 minutes))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Piotr Palaczyński

Principal Investigator

Medical University of Silesia

研究点 (2)

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