| CTRI Number |
CTRI/2020/07/026804 [Registered on: 27/07/2020] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of vocal cords using newer technique in patients undergoing operations of thyroid: a prospective, observational study |
|
Scientific Title of Study
|
Fiberoptic bronchoscope guided assessment of vocal cords using Bailey’s maneuver with I-gel supraglottic airway device in patients undergoing thyroid surgery: a prospective, 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 |
NARENDER KALORIA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
PGIMER, CHANDIGARH |
| Address |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE, 4TH FLOOR, NEHRU HOSPITAL, PGIMER, SECTOR 12, CHANDIGARH
PGIMER, SECTOR 12, CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8872495145 |
| Fax |
|
| Email |
naren.keli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NARENDER KALORIA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
PGIMER, CHANDIGARH |
| Address |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE, 4TH FLOOR, NEHRU HOSPITAL, PGIMER, SECTOR 12, CHANDIGARH
PGIMER, SECTOR 12, CHANDIGARH
Chandigarh
CHANDIGARH
160011
India |
| Phone |
8872495145 |
| Fax |
|
| Email |
naren.keli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NARENDER KALORIA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
PGIMER, CHANDIGARH |
| Address |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE, 4TH FLOOR, NEHRU HOSPITAL, PGIMER, SECTOR 12, CHANDIGARH
PGIMER, SECTOR 12, CHANDIGARH
Chandigarh
CHANDIGARH
160011
India |
| Phone |
8872495145 |
| Fax |
|
| Email |
naren.keli@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER CHANDIGARH |
| Address |
PGIMER SECTOR 12 CHANDIGARH |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| NARENDER KALORIA |
NEHRU HOSPITAL, PGIMER, SECTOR 12, CHANDIGARH |
OPERATION THEATRE, 5TH FLOOR
Chandigarh
CHANDIGARH |
8872495145
naren.keli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C73||Malignant neoplasm of thyroid gland, (2) ICD-10 Condition: E078||Other specified disorders of thyroid, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS WHO UNDERGOING THYROID SURGERY |
|
| ExclusionCriteria |
| Details |
1. ASA > II
2. Emergency surgery
3. Contraindication for I gel® SAD placement
4. Pre-existing VC palsy
5. Obesity (BMI>35 kg/m2)
6. Refusal to give consent for participation in the study
7. Patients at high risk for aspiration
8. Anticipated difficult airway |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fiberoptic bronchoscope guided visualization of VC with Bailey’s maneuver using I gel® SAD in patients undergoing thyroid surgery. |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the incidence of VC palsy following thyroid surgery
2. Grading of glottic view with FOB (Annexure 1)
3. Haemodynamic response during VC assessment
4. Time taken for VC assessment (starts from insertion of I gel to VC assessment)
5. Patient reactivity score during VC assessment.
6. Surgeon satisfaction score for appreciation of VC.
7. Adverse event related to the Bailey’s maneuver. |
one year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2020 |
| Date of Study Completion (India) |
20/12/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Iatrogenic injury to laryngeal nerves during thyroid
surgery is a common complication, that occurs because of their close proximity
to thyroid and parathyroid gland. Laryngeal mask exchange (Bailey’s maneuver) had been
described for extubation in deep anaesthesia plane in Difficult Airway Society
(DAS) guidelines 2012 for extubation and All India Difficult Airway association
(AIDAA) for anticipated difficult
extubation. Fibreoptic bronchoscope (FOB) inserted over the stem
of Supraglottic Airway Device (SAD) which can be used to look at the correct positioning
and mobility of vocal cords (VC) after thyroid surgery. |