A study to check whether the distance between bony condyle and ear tragus measured with the patient wearing surgical mask will be able to predict difficulty in giving breath via face mask under anaesthesia.

Not yet recruiting

• Registration Number: CTRI/2023/08/055978
• Lead Sponsor: Maulana Azad Medical College

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-07-31
• Study Start: 2023-10-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

• Patients scheduled for surgery under general anaesthesia requiring face mask ventilation.
• Age 18 years and above 2.
• American Society of Anesthesiologists physical grade I, II, III.

Exclusion Criteria

• 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 less than 6 cm, Sternomental distance less than 12 cm following standard technique 6.
• Limited head and neck movement.
• History of sleep apnea 9.
• Neck circumference greater than or equal to 40 cm.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Condyle tragus distance with mouth open (in finger breadth & mm) measured while wearing surgical mask for prediction of DMV (Warters scale ≥ 2)	Warters scale will be measured 30 sec after loss of eyelash.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Lok Nayak Hospital; 🇮🇳 Central, DELHI, India

Lok Nayak Hospital

🇮🇳Central, DELHI, India

Dr Harshita

Principal investigator

9711043667

harshita.sangat@gmail.com