| CTRI Number |
CTRI/2020/11/029116 [Registered on: 13/11/2020] Trial Registered Prospectively |
| Last Modified On: |
12/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To see the vocal cord movements following thyroid surgeries by using three different laryngoscopes |
|
Scientific Title of Study
|
Comparison of efficacy of Mcintosh, Mcgrath and Airtraq laryngoscopes for
assessment of vocal cord mobility following thyroid surgeries
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sindhuja Jillella |
| Designation |
Junior Resident |
| Affiliation |
NIZAM INSTITUTE OF MEDICAL SCIENCES |
| Address |
Room no 322, Doctors Club, Nizam Institute Of Medical Sciences, Punjagutta, Hyderabad.
Hyderabad
TELANGANA
500082
India |
| Phone |
8466900961 |
| Fax |
|
| Email |
sindhujajillella@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sindhuja Jillella |
| Designation |
Junior Resident |
| Affiliation |
NIZAM INSTITUTE OF MEDICAL SCIENCES |
| Address |
Room no 322, Doctors Club, Nizam Institute Of Medical Sciences, Punjagutta, Hyderabad.
Hyderabad
TELANGANA
500082
India |
| Phone |
8466900961 |
| Fax |
|
| Email |
sindhujajillella@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr kavita J |
| Designation |
Associate Professor |
| Affiliation |
Nizams Institute Of Medical Sciences |
| Address |
Department of Anaesthesia and Intensive Care, Speciality Block, Nizams Institute of Medical Sciences(NIMS), Punjagutta, Hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
8143769301 |
| Fax |
|
| Email |
drkarunya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizam Institute of Medical Sciences, Punjagutta, Hyderabad, Telangana 500082 |
|
|
Primary Sponsor
|
| Name |
Sindhuja Jillella |
| Address |
Room no 322, Doctors Club, Nizam Institute Of Medical Sciences, Punjagutta, Hyderabad. |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Dr J Sindhuja |
Nizam Institute Of Medical Sciences |
Department of anaesthesiology and intensive care, NIMS,Punjagutta,Hyderabad.
Hyderabad
TELANGANA |
8466900961
sindhujajillella@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, (2) ICD-10 Condition: E018||Other iodine-deficiency related thyroid disorders and allied conditions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laryngoscopy with normal laryngoscope |
comparison of efficacy of Macintosh,Mcgrath and Airtraq laryngoscopes for assessment of vocal cord mobility following thyroid surgeries at the time of extubation
|
| Comparator Agent |
Videolaryngoscope |
To compare laryngoscopic view, vocal cord mobility during extubation between Macintosh laryngoscope, McGrath and Airtraq videolaryngoscopes in thyroid surgeries. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2
Thyroid surgeries
Normal airway parameters
|
|
| ExclusionCriteria |
| Details |
Anticipated difficult postop laryngoscopy (as assessed at the time of intubation)
Pregnancy
Anticipated difficult intubation
Uncontrolled diabetics and hypertensives
Obesity or history of obstructive sleep apnea
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare laryngoscopic view, vocal cord mobility between Macintosh laryngoscope, McGrath and Airtraq videolaryngoscopes |
vocal cord mobility comparison between Macintosh, McGrath and Airtraq videolaryngoscopes at the time of extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| time taken for visualizing cords |
from introduction of laryngoscope into patient’s mouth, till complete visualization of vocal cords followed by removal of scope |
| patient reactivity score |
extubation |
| patient comfort |
Ramsay sedation scale at extubation,10 min20 min ,30 min thereafter |
| complications like laryngospasm |
after extubation |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
20/11/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
:Injury to the nerves following thyroid
surgery is more common among the complications evaluated. Accurate and timely
evaluation of vocal cord function relieves the stress of both surgeon and anesthesiologist
along with optimizing ongoing management. Conventional direct laryngoscopy is
the commonly used tool for vocal cord assessment during extubation in thyroid
surgeries.Videolaryngoscopes, the new entrant in the airway
armamentarium, are not well researched as an equipment to prognosticate extubation
in thyroid surgery. Appropriate visualization and assessment of vocal cords
during extubation with videolaryngoscopes can be useful for record keeping and
documentation. This study was therefore conducted to compare the conventional
direct laryngoscopy with prototypes of channeled and non-channeled
videolaryngoscopes – Airtraq and McGrath respectively for extubation in thyroid
surgery. |