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CTRI Number  CTRI/2024/04/065316 [Registered on: 05/04/2024] Trial Registered Prospectively
Last Modified On: 28/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Single Arm Study 
Public Title of Study   Ultrasonographic examination of the neck & oral cavity of patients who have suffered brain injury to predict difficult airway 
Scientific Title of Study   Role of Ultrasonographic parameters in predicting difficult airway in patients with acute brain injury-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  Dr Priyasmita Sarkar 
Designation  DM Resident, Neuroanaesthesia & Neurocritical Care 
Affiliation  National Institute of Mental Health and Neuro Sciences 
Address  Department of Neuroanaesthesia & Neurocritical Care,3rd floor, Neuroscience Faculty Block, Hospital Campus, NIMHANS, Hosur Road, Dharmaram P.O., Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  9582986210  
Fax    
Email  priyasmitasarkar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gopalakrishna KN 
Designation  Professor, Neuroanaesthesia & Neurocritical Care 
Affiliation  National Institute of Mental Health and Neuro Sciences 
Address  Department of Neuroanaesthesia & Neurocritical Care,3rd floor, Neuroscience Faculty Block, Hospital Campus, NIMHANS, Hosur Road, Dharmaram P.O., Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  9916469626  
Fax    
Email  gops868@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gopalakrishna KN 
Designation  Professor, Neuroanaesthesia & Neurocritical Care 
Affiliation  National Institute of Mental Health and Neuro Sciences 
Address  Department of Neuroanaesthesia & Neurocritical Care,3rd floor, Neuroscience Faculty Block, Hospital Campus, NIMHANS, Hosur Road, Dharmaram P.O., Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  9916469626  
Fax    
Email  gops868@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Mental Health And Neuro Sciences 
 
Primary Sponsor  
Name  Dr. Priyasmita Sarkar 
Address  3rd Floor, Neuroscience Faculty Block, Hospital Campus, NIMHANS, Hosur Road, Dharmaram P.O., Bengaluru 560029 Karnataka 
Type of Sponsor  Other [Principal Investigator] 
 
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 Priyasmita Sarkar  National Institute of Mental Health And Neuro Sciences  Department of Neuroanaesthesia & Neurocritical Care,3rd Floor, Neuroscience faculty Block, NIMHANS, Hospital Campus, Hosur Road, P.O. Dharmaram ,Bengaluru, Karnataka 560029
Bangalore
KARNATAKA 		 9582986210

priyasmitasarkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMHANS ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G939||Disorder of brain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Acute brain injury patients aged 18-75 years with altered sensorium undergoing emergency/elective surgery 
 
ExclusionCriteria 
Details  intubated patients
Poor/Inadequate ultrasound window
Pregnant patients
Patients with known upper airway anomalies & surgery
Refusal to consent
Planned awake fibreoptic bronchoscopy guided intubation in anticipated difficult airway 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the ultrasonographic parameters that predict difficult airway in patients with acute brain injury  At baseline, before induction of anaesthesia on the day of surgery/intervention 
 
Secondary Outcome  
Outcome  TimePoints 
i)To estimate the incidence of difficult airway in patients with acute brain injury
ii)to compare the prediction of difficult airway by routine preoperative airway assessment with ultrasonographic parameters in acute brain injury patients
iii) to estimate the need of airway adjuncts, maneuvers & alternative intubation techniques for airway management in these patients
iv)To estimate the incidence of airway adverse events, if any
 		 At baseline after induction of general anaesthesia at the time of bag & mask ventilation & at the time of intubation 
 
Target Sample Size   Total Sample Size="230"
Sample Size from India="230" 
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)   15/04/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Airway management comprises a critical component of anesthesia practice. Difficult airway may lead to a multitude of complications ranging from hypoxia, hypercarbia to cardiac arrest & death. Routine clinical airway assessment can successfully predict difficult airway in conscious cooperative patients. However acute brain injury patients pose a unique challenge in this regard as they do not cooperate for routine airway assessment due to altered mental status. Hence routine airway assessment in these patients may be insufficient & inadequate to predict difficult airway. Failing to identify difficult airway  may lead to airway complications leading to hypoxia or hypercarbia which might further increase the overall morbidity & mortality in these patients. Ultrasonography is a quick bed side tool which can be easily used to examine the airway anatomy in these patients. Various ultrasonographic parameters like tongue thickness, visibility of the hyoid bone, hyomental distance, anterior soft tissue thickness of the neck at the level of hyoid, thyrohyoid membrane & vocal cords have successfully predicted difficult airway with varying degrees of sensitivity & specificity. However, no literature is available on the validity & accuracy of these parameters in predicting difficult airway in brain injured patients.  Hence the primary purpose of the study is to determine the ultrasonographic parameters that predict difficult airway in patients with acute brain injury. 
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