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CTRI Number  CTRI/2025/01/079597 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 20/01/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A Study To Identify Post-operative Vocal Cord Function Comparing Bronchospy And Ultrasound.  
Scientific Title of Study   Comparision of fibreoptic bronchoscopy with trans-laryngeal ultrasound for functional assessment of vocal cords post-extubation in thyroid and parathyroid surgeries - a prospective observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anne Kiran Kumar 
Designation  Professor 
Affiliation  Nizams Institute of Medical Sciences 
Address  Department of Anesthesiology,Nizams Institute of Medical Sciences, Hyderabad, India

Hyderabad
TELANGANA
500082
India 
Phone  9052709777  
Fax    
Email  kirankumaranne@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Anne Kiran Kumar 
Designation  Professor 
Affiliation  Nizams Institute of Medical Sciences 
Address  Department of Anesthesiology,Nizams Institute of Medical Sciences, Hyderabad, India

Hyderabad
TELANGANA
500082
India 
Phone  9052709777  
Fax    
Email  kirankumaranne@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Anne Kiran Kumar 
Designation  Professor 
Affiliation  Nizams Institute of Medical Sciences 
Address  Department of Anesthesiology,Nizams Institute of Medical Sciences, Hyderabad, India


TELANGANA
500082
India 
Phone  9052709777  
Fax    
Email  kirankumaranne@yahoo.com  
 
Source of Monetary or Material Support  
Nizams Institute of Medical Sciences, Hyderabad, India Pincode: 500082 
 
Primary Sponsor  
Name  Nizams Institute of Medical Sciences 
Address  Department of Anesthesiology,Nizams Institute of Medical Sciences, Hyderabad, India - 500082 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anne Kiran Kumar  Nizams Institute of Medical Sciences  Operation Theatre 3 & 4, Speciality Block Operation Theatre, Department of Anesthesiology,Nizams Institute of Medical Sciences, Hyderabad, India
Hyderabad
TELANGANA 
9052709777

kirankumaranne@yahoo.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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  comparator group  NIL 
Intervention  Intervention Group  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  patients posted for thyroid surgery(total or subtotal or hemithyroidectomy), parathyroid surgery, radical or functional neck dissection surgeries. 
 
ExclusionCriteria 
Details  patients with coronary artery disease, cerebrovascular disease, pregnant patients, pediatric patients, emergency front-of-neck surgeries, patients who are not willing for consent for the surgery. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To compare the efficacy of trans laryngeal ultrasound over fibreoptic bronchoscope for assessing vocal cord palsy at/after extubation.  baseline/ preoperatively immediately before surgery, at the end of surgery, at 2 days postoperatively and at 2 month follow up post surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1. Time taken to assess VC mobility during both the techniques.
2. Assessment of displacement from the midline in case of palsy using both techniques.
3. Assessment for change in vocal cord displacement velocity (VCDV) by TL-USG
 
baseline/ preoperatively immediately before surgery, at the end of surgery, at 2 days postoperatively and at 2 month follow up post surgery 
 
Target Sample Size   Total Sample Size="157"
Sample Size from India="157" 
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)   01/02/2025 
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 Yet Recruiting 
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
Brief Summary  

Functional vocal cord (VC) maintenance is essential in thyroidectomies1. Nerve injury is a significant complication during thyroidectomy2, leading to vocal cord palsy. So, assessing the vocal cord function before and after surgery is mandatory. Direct visualisation of vocal cords using laryngoscopy at the time of extubation is routinely done, but at the same time, it is associated with higher sympathetic stimulation, leading to hypertension, tachycardia, and patient discomfort. So, visualisation of vocal cords using the fibreoptic bronchoscope (FOB), though semi-invasive, is considered the reference standard3-5 but sparingly used for perioperative detection of VC palsies due to various reasons. Other methods for assessment of vocal cord function include indirect laryngoscopy (IDL), laryngeal muscles electromyography (LME), computed tomography (CT), and magnetic resonance imaging (MRI). Trans laryngeal ultrasonography (TL-USG) is a valuable non-invasive method for assessing VC anatomy and functionality. More literature is needed comparing FOB with TL-USG to assess VC morphology and mobility. The efficacy and non-inferiority of TL-USG over FOB-guided VC assessment have not been evaluated. We hypothesise Trans laryngeal ultrasonography(TL-USG) is comparable to FOB in identifying post-operative vocal cord palsy in real-time view.

nclusion criteria: Patients belonging to ASA1-3 between ages 18 and 70 who are posted for thyroid and parathyroid surgeries.

Exclusion Criteria: Patients with coronary artery disease (CAD), history of cerebrovascular accident (CVA), and pregnant patients will be excluded from the study. 

Methodology: After institutional ethics committee approval and informed consent, patients posted for thyroid and parathyroid surgeries belonging to ASA class 1-3, aged 18-70 years, will be enrolled in the study. As a part of the routine preoperative surgical work up, these patients will be evaluated for vocal cord movements using indirect laryngoscopy (IDL)  by a well experienced surgeon. All those patients with preoperative vocal cord palsy will be excluded from the study. The patients will be explained about coughing, phonation like making a continuous sound like aaa for easy assessment of VC movements and the same will be asked to be reproduced post extubation on the operating table on request. TL-USG will be performed preoperatively under the domains like Visualisation of vocal cord, Symmetry, position, and mobility of vocal cords, Paresis: decreased movements of vocal folds, Paralysis: complete loss of mobility of vocal cord/s, Time to visualize VC mobility by an experienced anesthesiologist. TL-USG will be done on the anterior neck in thyroid view6 with a high-frequency linear probe (frequency: 8–12 MHz). Patients will lay supine with their necks slightly extended and the ultrasound transducer will be positioned transversely over the anterior aspect of the middle portion of the thyroid cartilage, serving as acoustic window. Vocal cords will be assessed by scanning transducer caudo-cranially. Image will be optimised so that false cords will be seen as hyperechoic structures, while true cords seen as hypoechoic structures. VC mobility will be evaluated during passive spontaneous breathing, active phonation with a sustained vowel ‘‘aaa”. Normal mobility of the true vocal cords will be characterized by symmetrical movement in adduction and abduction. Preoperative VCDV will be noted and compared with the post operative VCDV.

All patients will receive premedication with tab alprazolam 0.25 mg and tab ranitidine 150 mg in the morning of surgery. In the operating theatre, intravenous access will be secured and intravenous fluids started; the patient will be connected to standard American Society of Anesthesiologists monitors (electrocardiogram, pulse oximeter, non-invasive blood pressure). Patient will be induced with fentanyl 2 mcg/kg, propofol 2 mg/kg and atracurium 0.5 mg/kg. Patients will be preoxygenated with 100% oxygen for 3 minutes with a fresh gas flow of 6 L/min in closed circuit. Patients will be intubated with an appropriately sized endotracheal tube using a standard Macintosh laryngoscope. Anaesthesia will be maintained with oxygen and air in a ratio of 50:50, with fresh gas flow of 2 L/min and sevoflurane to maintain a minimum alveolar concentration (MAC) around 1. Intermittent boluses of atracurium were used to maintain muscle paralysis in the intraoperative period.

At the beginning of skin closure MAC will be maintained at 0.3 with Sevoflurane. An anesthesiologist with adequate bronchoscopy experience introduces a flexible fibreoptic bronchoscope into one of the nostrils, and the tip of the scope is just positioned where the glottic view is best obtained. After completion of skin closure, sevoflurane will be switched off. When the patients are awake, obeying commands, arousable, and having attained regular spontaneous breathing, are adequately reversed with neostigmine 0.05 mg/kg and glycopyrrolate 0.01 mg/kg. immediately after the endotracheal tube has been removed, the vocal cord movements will be assessed, and the following findings are noted. Visualisation of vocal cord, Symmetry, position, and mobility of vocal cords, Paresis: decreased movements of vocal folds, Paralysis: complete loss of mobility of vocal cord/s, Time to visualize VC mobility.

The anesthesiologists performing FOB and TL-USG are blinded to each other’s findings and also to preoperative IDL findings. A third anesthesiologist will compare the findings of preoperative IDL, FOB-guided VC assessment findings, and TL-USG-guided VC assessment findings. IDL will be performed routinely for all patients undergoing thyroid and parathyroid surgeries at discharge and two-month follow-up. These findings will be compared with those of FOB and TL-USG findings done immediately after extubation.

Sample size calculation:

As per a study by Shetmahajan et al., who compared trans laryngeal ultrasonography with flexible laryngoscopy and Hopkins endoscope for vocal cord assessment, Cohen’s Kappa Coefficient was 0.69 for flexible laryngoscopy in concordance with TL USG. To detect a discordance (kappa of 0.8) between TLUSG and FOB at 80% power, the expected sample size is 149. Using the previous institutional data, a 30% incidence of postoperative vocal cord palsy was used for sample size calculation. For a dropout rate of 5%, a total of 157 patients will be enrolled in the study.

 
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