| CTRI Number |
CTRI/2022/11/047310 [Registered on: 15/11/2022] Trial Registered Prospectively |
| Last Modified On: |
29/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To check the role of voice recorded before surgery on predicting difficult face mask ventilation under anesthesia |
|
Scientific Title of Study
|
Evaluation of the role of preoperative voice assessment for prediction of difficult face mask ventilation: an observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shweta Prajapati |
| Designation |
PG resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no. 308, 3rd floor BLT block , Maulana Azad Medical college 2,Bahadurshah Zafar Marg, New Delhi -110002
Central
DELHI
110002
India |
| Phone |
9910482317 |
| Fax |
|
| Email |
shweta08320@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kapil Chaudhary |
| Designation |
Professor ( doctor ) |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no. 313, 3rd floor BLT block , Maulana Azad Medical college 2,Bahadurshah Zafar Marg, New Delhi -110002
Central
DELHI
110002
India |
| Phone |
9871262699 |
| Fax |
|
| Email |
kapsdr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Prajapati |
| Designation |
PG resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no. 308, 3rd floor BLT block , Maulana Azad Medical college 2,Bahadurshah Zafar Marg, New Delhi -110002
Central
DELHI
110002
India |
| Phone |
9910482317 |
| Fax |
|
| Email |
shweta08320@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 Anaesthesia & Intensive Care, Lok Nayak Hospital and associated Maulana Azad Medical College
2, Bahadurshah Zafar Marg, New Delhi 110002 |
| Type of Sponsor |
Government medical college |
|
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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 Shweta Prajapati |
Lok Nayak Hospital, Maulana Azad Medical College |
Ot block, Department of Anaesthesia & Intensive Care, Maulana Azad medical college & associated Lok Nayak Hospital 2,Bahadur shah Zafar Marg , New delhi 110002
Central
DELHI |
9910482317
shweta08320@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMC IEC |
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: C390||Malignant neoplasm of upper respiratory tract, part unspecified, (2) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (3) ICD-10 Condition: C579||Malignant neoplasm of female genital organ, unspecified, (4) ICD-10 Condition: C689||Malignant neoplasm of urinary organ, unspecified, (5) ICD-10 Condition: C759||Malignant neoplasm of endocrine gland, unspecified, (6) ICD-10 Condition: C801||Malignant (primary) neoplasm, unspecified, (7) ICD-10 Condition: C801||Malignant (primary) neoplasm, unspecified, (8) ICD-10 Condition: K319||Disease of stomach and duodenum, unspecified, (9) ICD-10 Condition: K389||Disease of appendix, unspecified, (10) ICD-10 Condition: K469||Unspecified abdominal hernia without obstruction or gangrene, (11) ICD-10 Condition: K566||Other and unspecified intestinal obstruction, (12) ICD-10 Condition: K629||Disease of anus and rectum, unspecified, (13) ICD-10 Condition: K769||Liver disease, unspecified, (14) ICD-10 Condition: K808||Other cholelithiasis, (15) ICD-10 Condition: K829||Disease of gallbladder, unspecified, (16) ICD-10 Condition: K839||Disease of biliary tract, unspecified, (17) ICD-10 Condition: K869||Disease of pancreas, unspecified, (18) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (19) ICD-10 Condition: K929||Disease of digestive system, unspecified, (20) ICD-10 Condition: K940||Colostomy complications, (21) ICD-10 Condition: N509||Disorder of male genital organs, unspecified, (22) ICD-10 Condition: N289||Disorder of kidney and ureter, unspecified, (23) ICD-10 Condition: N289||Disorder of kidney and ureter, unspecified, (24) ICD-10 Condition: N630||Unspecified lump in unspecified breast, (25) ICD-10 Condition: N649||Disorder of breast, unspecified, (26) ICD-10 Condition: N74||Female pelvic inflammatory disorders in diseases classified elsewhere, (27) ICD-10 Condition: L989||Disorder of the skin and subcutaneous tissue, unspecified, (28) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (29) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, (30) ICD-10 Condition: H948||Other specified disorders of ear in diseases classified elsewhere, (31) ICD-10 Condition: H758||Other specified disorders of middle ear and mastoid in diseases classified elsewhere, (32) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, (33) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified, (34) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, (35) ICD-10 Condition: D249||Benign neoplasm of unspecified breast, (36) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18 yrs and above
2.American Society Of Anaesthesiologist physical grade I,II,III |
|
| ExclusionCriteria |
| Details |
1.Patients in whom achieving a proper mask seal will be difficult including but not limited to edentulous, beard, scars,swellings, dressings over the face
2.Patients with known nasal, oral or laryngeal pathologies
3. Patients who are unable to pronounce vowels and consonants of study
4. Patients requiring rapid sequence intubation
5.Participants with a previous history of speech disorders, vocal cord disease, cleft palate, craniofacial syndromes, hearing or perception abnormalities, mental or central nervous system disease
6.Pregnant woman |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between preoperative voice formants and difficult facemask ventilation |
1 minute after muscle relaxant administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Association between preoperative voice bandwidth an difficult facemask ventilation
2. Association between preoperative voice pitch and difficult facemask ventilation |
1 minutes after muscle relaxant administration |
|
|
Target Sample Size
|
Total Sample Size="269"
Sample Size from India="269"
Final Enrollment numbers achieved (Total)= "312"
Final Enrollment numbers achieved (India)="312" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/11/2022 |
| Date of Study Completion (India) |
14/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Face mask ventilation is an essential aspect of airway management in general anaesthesia and identification of risk factors to predict it assumes importance. Voice has recently been used to evaluate difficult airway.
The aim of this study would be to evaluate the role of preoperative voice assessment for prediction of difficult facemask ventilation. ASA I-III patients undergoing elective surgery under general anaesthesia would have their voice assessment preoperatively and difficulty in facemask ventilation would be assessed intraoperatively. |