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CTRI Number  CTRI/2022/11/047478 [Registered on: 21/11/2022] Trial Registered Prospectively
Last Modified On: 03/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Thyromental height(the vertical height between the chin and the thyroid cartilage)as a predictor of difficult view on laryngoscopy in patients undergoing neurosurgical procedures. 
Scientific Title of Study   Thyromental height as a predictor of difficult laryngoscopic view in neurosurgical patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anjana N Kutty 
Designation  Junior Resident 
Affiliation  PGIMER 
Address  Dept of Anaesthesia and Intensive Care 4rth floor Nehru Hospital PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  8722083751  
Fax    
Email  swtnarayan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Narender Kaloria 
Designation  Assistant professor 
Affiliation  PGIMER 
Address  Dept of Anaesthesia and Intensive Care 4rth floor Nehru Hospital PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  8872495145  
Fax    
Email  naren.keli@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anjana N Kutty 
Designation  Junior Resident 
Affiliation  PGIMER 
Address  Dept of Anaesthesia and Intensive Care 4rth floor Nehru Hospital PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  8722083751  
Fax    
Email  swtnarayan@gmail.com  
 
Source of Monetary or Material Support  
PGIMER, Research grant dept of anaesthesia, 4rth floor, Nehru hospital,PGIMER 
 
Primary Sponsor  
Name  PGIMER 
Address  Institutional Ethics Committee,PGIMER,Chandigarh,160012 
Type of Sponsor  Research institution 
 
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 
Anjana N Kutty  PGIMER neurosurgery operation theater  Nehru Hospital, PGIMER, Chandigarh, 160012
Chandigarh
CHANDIGARH 		 8722083751

swtnarayan@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Neurosurgical patients undergoing surgery for glioma, aneurysm,c spine, traumatic brain injury, vp shunt, cerebellar lesions, brainstem lesions under general anaesthesia. 
 
ExclusionCriteria 
Details  Cervical spine abnormalities, pregnancy, facio maxillary deformity, BMI >30, neuromuscular disorders. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To demonstrate that thyromental height has a sensitivity and specificity of more than 75% in predicting a difficult laryngoscopes view.  Within 24 hours of surgery and Cormack Lehane grading upon intubation. 
 
Secondary Outcome  
Outcome  TimePoints 
To calculate a cut off value for thyromental height.
To calculate the positive predictive value, negative predictive value and accuracy of thyromental height in predicting a difficult laryngoscopes view.
To calculate the efficacy of thyromental height as a predictor of difficult intubation.
Comparison of Thyromental height with other routinely used bedside airway parameters such as Mallampati grade and thyromental distance. 		 in a span of one year 
 
Target Sample Size   Total Sample Size="562"
Sample Size from India="562" 
Final Enrollment numbers achieved (Total)= "562"
Final Enrollment numbers achieved (India)="562" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/11/2022 
Date of Study Completion (India) 30/09/2023 
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)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Probably after trial completion 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [swtnarayan@gmail.com].

  6. For how long will this data be available start date provided 03-11-2022 and end date provided 03-11-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary
Modification(s)  		 The hypothesis is that Thyromental height will have a higher sensitivity in predicting a difficult laryngoscopic view than routinely performed airway assessment parameters such as Modified Mallampati Test and Thyromental Distance.
The primary objective will be to arrive at a sensitivity/specificity of more than 75% of thyromental height in predicting a difficult laryngoscopic view.
The secondary objectives would be 1)to arrive at a cut off value for thyromental height to predict difficult laryngoscopic view, 2)PPV,NPV and accuracy of thyromental height and 3)To compare Thyromental height with Modified Mallampati test and thyromental distance.
The study will target to recruit 562 patients undergoing neurosurgical procedures. Due to the limited time frame however at least 250 patients will be recruited. The thyromental height will be measured along with other airway parameters during the Pre anaesthesia evaluation and will be done within 12 hours of surgery. The intubation will be carried out an experienced anaesthesiologist of at least 3 years experience and the Cormack Lehane grading will be recorded. 
A difficult laryngoscopic view will be defined as a grade of 3 or 4. 


 
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