| CTRI Number |
CTRI/2023/08/055978 [Registered on: 01/08/2023] Trial Registered Prospectively |
| Last Modified On: |
31/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
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. |
|
Scientific Title of Study
|
Preoperative evaluation of condyle tragus distance with patient wearing
surgical mask for prediction of difficult face mask ventilation. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harshita |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology, B.L. Taneja block, 3rd floor, Maulana Azad Medical College and associated hospitals,Bahadurshah Zafar Marg, New Delhi-110002
Central
DELHI
110002
India |
| Phone |
9711043667 |
| Fax |
|
| Email |
harshita.sangat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kapil Chaudhary |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no. 313,BL Taneja block, 3rd floor,Maulana Azad Medical College and associated hospitals,Bahadurshah Zafar Marg, New Delhi - 110002
Central
DELHI
110002
India |
| Phone |
9968604504 |
| Fax |
|
| Email |
kapsdr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshita |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology,B.L. Taneja block, 3rd floor,Maulana Azad Medical College and associated hospitals,Bahadurshah Zafar Marg,New Delhi-110002
Central
DELHI
110002
India |
| Phone |
9711043667 |
| Fax |
|
| Email |
harshita.sangat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Lok Nayak Hospital |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
OT blocks, Department of Anaesthesiology,Lok Nayak Hospital and associated Maulana Azad Medical College, Bahadurshah Zafar Marg,New Delhi-110002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harshita |
Lok Nayak Hospital |
Department of Anaesthesiology, Maulana Azad Medical College, New Delhi-110002
Central
DELHI |
9711043667
harshita.sangat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Maulana Azad Medical College |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, (2) ICD-10 Condition: C30-C39||Malignant neoplasms of respiratory and intrathoracic organs, (3) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, (4) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, (5) ICD-10 Condition: C64-C68||Malignant neoplasms of urinary tract, (6) ICD-10 Condition: C73-C75||Malignant neoplasms of thyroid and other endocrine glands, (7) ICD-10 Condition: C76-C80||Malignant neoplasms of ill-defined, other secondary and unspecified sites, (8) ICD-10 Condition: K20-K31||Diseases of esophagus, stomach and duodenum, (9) ICD-10 Condition: K55-K64||Other diseases of intestines, (10) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, (11) ICD-10 Condition: K35-K38||Diseases of appendix, (12) ICD-10 Condition: K56||Paralytic ileus and intestinal obstruction without hernia, (13) ICD-10 Condition: K40-K46||Hernia, (14) ICD-10 Condition: K60||Fissure and fistula of anal and rectal regions, (15) ICD-10 Condition: K631||Perforation of intestine (nontraumatic), (16) ICD-10 Condition: N70-N77||Inflammatory diseases of female pelvic organs, (17) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (18) ICD-10 Condition: O60-O77||Complications of labor and delivery, (19) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, (20) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, (21) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, (22) ICD-10 Condition: K70-K77||Diseases of liver, (23) ICD-10 Condition: N60-N65||Disorders of breast, (24) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for surgery under general anaesthesia requiring face mask ventilation.
1. Age 18 years and above
2. American Society of Anesthesiologists physical grade I, II, III |
|
| ExclusionCriteria |
| Details |
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 less than 6 cm, Sternomental distance less than 12 cm following standard technique
6. Limited head and neck movement.
7. BMI greater than or equal to 30 kg/m2
8. History of sleep apnea
9. Neck circumference greater than or equal to 40 cm |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
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
|
| Outcome |
TimePoints |
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.
|
Warters scale will be measured 30 sec after loss of eyelash. |
|
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Target Sample Size
|
Total Sample Size="225"
Sample Size from India="225"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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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 ≥ 30 kg/m2 8. History of sleep apnea 9. Neck circumference ≥ 40 cm
|