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临床试验/CTRI/2023/08/055978
CTRI/2023/08/055978尚未招募不适用

Preoperative evaluation of condyle tragus distance with patient wearingsurgical mask for prediction of difficult face mask ventilation.

Maulana Azad Medical College1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2023年10月8日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
225
试验地点
1
主要终点
Condyle tragus distance with mouth open (in finger breadth & mm) measured while wearing surgical mask for prediction of DMV (Warters scale ≥ 2)

研究概览

简要总结

Face mask ventilation is crucial for airway management under general anaesthesia to maintain airway patency for optimal oxygenation of tissues.

The routine examination such as inter incisor distance(IID), Mallampati classification, and upper lip bite test(ULBT) require a patient to open his mouth and exposes the anaesthesiologist to patient’s upper respiratory tract with risk of airborne infections (coronavirus, tuberculosis, Influenza, pneumonia).

Our aim is to evaluate condyle tragus distance measured while patient wearing surgical mask for prediction of difficult face mask ventilation.

Our primary objective is to evaluate condyle tragus distance (mouth open) while wearing surgical mask for prediction of difficult mask ventilation.

Our secondary objective is to:

1) To evaluate condyle tragus distance (jaw protruded) while wearing surgical mask for prediction of difficult mask ventilation.

2) To compare direct temporomandibular joint mobility indicators measured while wearing surgical mask (condyle tragus distance with mouth open and jaw protruded) with indirect temporomandibular joint mobility indicators measured without surgical mask (inter incisor distance, modified Mallampati classification, and upper lip bite test) for prediction of difficult mask ventilation.

Inclusion criteria:

1. Age 18 years and above

2. American Society of Anesthesiologists physical grade I, II, III

 Exclusion criteria:

​​

1. Patients in whom difficulty in achieving a proper face mask seal would be identifiable with patient wearing surgical mask including but not limited to visible beard, visible swelling on face, dressing over face

2. Patients with maxillofacial injuries

3. Edentulous

4. Patients unable to cooperate

5. Thyromental distance < 6 cm, Sternomental distance < 12 cm following standard technique

6. Limited head and neck movement.

7. BMI â‰¥ 30 kg/m2

8. History of sleep apnea

9. Neck circumference ≥ 40 cm

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients scheduled for surgery under general anaesthesia requiring face mask ventilation.
  • Age 18 years and above
  • American Society of Anesthesiologists physical grade I, II, III.

排除标准

  • Patients in whom difficulty in achieving a proper face mask seal would be identifiable with patient wearing surgical mask including but not limited to visible beard, visible swelling on face, dressing over face
  • Patients with maxillofacial injuries
  • Edentulous
  • Patients unable to cooperate
  • Thyromental distance less than 6 cm, Sternomental distance less than 12 cm following standard technique
  • Limited head and neck movement.
  • History of sleep apnea
  • Neck circumference greater than or equal to 40 cm.

结局指标

主要结局

Condyle tragus distance with mouth open (in finger breadth &amp; mm) measured while wearing surgical mask for prediction of DMV (Warters scale ≥ 2)

时间窗: Warters scale will be measured 30 sec after loss of eyelash.

次要结局

  • 1.Condyle tragus distance with jaw protruded (in finger breadth & mm) measured while wearing surgical mask for prediction of DMV (Warters scale ≥ 2)(2. Comparison of direct temporomandibular joint mobility indicators measured while wearing surgical mask (condyle tragus distance with mouth open & jaw protruded) with indirect temporomandibular joint mobility indicators measured without surgical mask (IID, MMP, & ULBT) for prediction of difficult mask ventilation.)

研究者

申办方类型
Government medical college

研究点 (1)

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