| CTRI Number |
CTRI/2021/12/038667 [Registered on: 15/12/2021] Trial Registered Prospectively |
| Last Modified On: |
24/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Laryngeal scan and Laryngoscopy in patients who underwent thyroid surgery |
|
Scientific Title of Study
|
To compare the efficacy of Transcutaneous Laryngeal Ultrasonography (TLUSG) and Direct Laryngoscopy in assessing the function of vocal cords postoperatively in Thyroidectomy patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parul Jindal |
| Designation |
Professor |
| Affiliation |
Himalayan Institute of Medical Sciences |
| Address |
Department of Anesthesia Himalayan Institute of Medical Sciences,Swami Rama Himalayan University
Dehradun
UTTARANCHAL
248140
India |
| Phone |
9456547229 |
| Fax |
|
| Email |
parulpjindal@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sreya Sri |
| Designation |
Post graduate resident |
| Affiliation |
Himalayan institute of medical sciences |
| Address |
Department of anesthesia
Himalayan institute of medical sciences
Swamiram Himalayan University
Jollygrant
Dehradun
UTTARANCHAL
248140
India |
| Phone |
09133976357 |
| Fax |
|
| Email |
sreyasrisirpurkar1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr sreya Sri |
| Designation |
Post graduate resident |
| Affiliation |
Himalayan institute of medical sciences |
| Address |
Department of anesthesia
Himalayan institute of medical sciences
Swamiram Himalayan University
Jollygrant
Dehradun
UTTARANCHAL
248140
India |
| Phone |
09133976357 |
| Fax |
|
| Email |
sreyasrisirpurkar1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, Himalayan Institute of Medical Sciences, Swami Ram Nagar,Jollygrant Dehradun |
|
|
Primary Sponsor
|
| Name |
Department of anesthesiology Himalayan Institute of Medical Sciences |
| Address |
Himalayan Institute of Medical Sciences Swami Rama Himalayan University Dehradun |
| Type of Sponsor |
Private medical college |
|
|
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 Parul Jindal |
Himalayan Institute ofMedical Sciences |
Himalayan Institute ofMedical SciencesInduction room, pre oparea, operation theatere2nd floor, Departmentof anaesthesia,CancerResearch Institute,Himalayan Institute ofMedical Sciences,Swami RamaHimalayan University,jollygrantDehradunUTTARANCHAL
Dehradun
UTTARANCHAL |
9456547229
parulpjindal@yahoo.co.in |
|
|
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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA physical status I and II of either sex
2.Age between 18-65 years
3.Scheduled for thyroid surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Patients belonging to asa IV
2. Pre-existing neurological disease affecting vocal cords
3. Patient with limited neck extension
4.patients with previous neck surgeries
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess of vocal cords by both laryngeal ultrasonography and direct laryngoscopy in compare which modality is better and provides good patient comfort in Thyroidectomy patients |
Opd vist - indirect laryngoscopy or laryngo endoscopy Preoperatively 30 minutes before induction of Anesthesia Laryngeal ultrasound by Anesthesiologist 10minutes before extubation direct Laryngoscopy and assesment of vocal colds
In first hour of postoperative period by 2nd Laryngeal ultrasound by different anesthesiologist followed by 5 days on the day of discharge indirect laryngoscopy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the heamodynamic parameters and patients comfort while assseing the vocal cords using both methods |
Blood pressure,heart rate,spo2, respiratory rate and mean arterial pressure are assesed before extubation and also noted at 1 min 2min 3 min 4 min 5 min during directlarunhiscopy
And similarly noted while performing Transcutaneous ultrasonography |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/12/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Vocal cord paresis or palsy caused as a result of recurrent laryngeal nerve injury is a complication of disquietude as it can also be a mainspring of medicolegal litigation. Hence the preservation of recurrent laryngeal nerve (RLN) becomes the most importa nt part of thyroid surgery. The incidence of recurrent laryngeal nerve injury varies, ranging from 0.4% to 7.2% for temporary paresis and from 0% to 5.2% for permanent paralysis
Commonly pati ents undergoing thyroidectomy are evaluated for postoperative recurrent laryngeal nerve function for vocal cord mobility with indirect laryngoscopy.The practice of examining the vocal cords in the immediate postoperative period just after the extubation for the presence of any vocal cord dysfunction is advocated by many surgeons. But, in two settings patients are exposed to unnecessary laryngoscopic examinations which often cause discomfort to the patient.Tran scutaneous ultrasound (USG) is a cheap, noninvasive substitute to the above methods for examining the patients to assess the vocal cord function routinely for elective Thyroidectomy both preoperatively and postoperatively.Wong KP, et al. conducted a study in which 204 patients underwent TLUSG and direct laryngoscopy before and after elective thyroidectomy. For both examinations, vocal cord movements were independently graded. To assess accuracy, TLUSG findings were correlated with direct l aryngoscopy findings. Postoperative TLUSG had a sensitivity, specificity, positive predictive value, and negative predictive value of 93.3%, 97.8%, 77.8%, and 99.4%, respectively.
STUDY DESIGN Type of study : Prospective Observational Cohort Study. Sample size and sampling methods : ee written informed consent will be The study of Wong KP, et al observed that sensitivity and specificity of TLUSG in di agnosing VCP were 93.3%, 97.8% respectively.(
Taking these values as reference, the minimum required sample size with desired precision of 15%, 80%power of study and5% level of significance is 32 patients. To reduce margin of error, total sample size taken is 40.
|