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CTRI Number  CTRI/2025/12/099783 [Registered on: 24/12/2025] Trial Registered Prospectively
Last Modified On: 17/09/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Other 
Public Title of Study   A study testing whether neck imaging can predict which patients will be difficult to intubate during upper cervical spine surgery 
Scientific Title of Study   Association of Radiological Parameters (X-ray, CT, MRI) with Difficult Video-Laryngoscopy Guided Intubation in Patients Posted for Upper Cervical Spine (C1-C4) Surgery: 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 ABHISHEK JANPURE 
Designation  SENIOR RESIDENT 
Affiliation  AIIMS,NEW DELHI 
Address  Department of Neuroanaesthesiology and Neurocritical Care,6th floor, Neurosciences Centre,AIIMS,New Delhi,India

New Delhi
DELHI
110029
India 
Phone  09174156474  
Fax    
Email  ABHIJANPURE675@GMAIL.COM  
 
Details of Contact Person
Scientific Query
 
Name  Dr Keshav Goyal 
Designation  Professor 
Affiliation  AIIMS,NEW DELHI 
Address  Department of Neuroanaesthesiology and Neurocritical Care, 6th floor, Neurosciences Centre, AIIMS, New Delhi, India

New Delhi
DELHI
110049
India 
Phone  9999079795  
Fax    
Email  Keshavgoyalster@gmail.com   
 
Details of Contact Person
Public Query
 
Name  Dr Keshav Goyal 
Designation  Professor 
Affiliation  AIIMS,NEW DELHI 
Address  Department of Neuroanaesthesiology and Neurocritical Care, 6th floor, Neurosciences Centre, AIIMS, New Delhi, India

New Delhi
DELHI
110049
India 
Phone  9999079795  
Fax    
Email  Keshavgoyalster@gmail.com   
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences Delhi,Sri Aurobindo Marg,Ansari Nagar East,New Delhi, 110029,INDIA 
 
Primary Sponsor  
Name  AIIMS,NEW DELHI 
Address  Department of Neuroanaesthesiology and critical care, oth floor, Neuroscience Centre, AIMS, New Delhi, India- 110029 
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 ABHISHEK JANPURE  AIIMS,NEW DELHI  Department of Neuroanaesthesiology and Neurocritical Care, 6th floor, Neurosciences Centre, AIIMS, New Delhi, India
New Delhi
DELHI 
9174156474

ABHIJANPURE675@GMAIL.COM 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS, New Delhi  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 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  a) Age: 18-65 years
b) Gender: Both male and female
c) ASA Physical Status: I-III
d) Pathology: Upper cervical spine disease involving C1-C4 levels including:
1. Atlantoaxial dislocation (traumatic/non-traumatic)
2. Traumatic cervical spine injury (C1-C4)
3. Craniovertebral junction (CVJ) anomalies
4. Cervical spondylosis with upper cervical involvement
5. Congenital cervical spine anomalies
6. Tumors involving upper cervical spine
e) Surgery: Elective procedures requiring general anaesthesia with endotracheal intubation
f) Consent: Written informed consent from patient or legally acceptable representative
 
 
ExclusionCriteria 
Details  a) Emergency surgery requiring immediate intervention
b) No imaging available
c) Already intubated patients
d) Limited mouth opening (less than 3 cm)
e) Previous tracheostomy or surgical airway
f) Facial trauma or oropharyngeal pathology affecting airway assessment
g) Pregnancy
h) Refusal of consent
i) Previous Failed intubation requiring surgical airway
j) ASA III-IV
k) Mental retardation
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence of difficult video-guided intubation, defined as more than 1 attempt or more than 60 seconds  Baseline,at the time of intubation 
 
Secondary Outcome  
Outcome  TimePoints 
1. Incidence of difficult video-laryngoscopy in patients with upper cervical spine disease.
2. Measurement of radiological parameters
3. Sensitivity, specificity, PPV & NPV of radiological parameters & traditional clinical tests.
 
1.At the time of analysis at completion of study
2.At basline
3.At the time of analysis 
 
Target Sample Size   Total Sample Size="55"
Sample Size from India="55" 
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)   04/01/2026 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

This is a prospective observational cohort study evaluating the association between radiological parameters derived from routine preoperative imaging (cervical X-ray, CT, and MRI) and difficult video-laryngoscopy guided intubation in patients with upper cervical spine (C1-C4) disease undergoing elective surgery.

Background: Patients with upper cervical spine disease demonstrate significantly higher incidence of difficult laryngoscopy (14.9-25%) compared to the general surgical population (4.5-9.7%). Traditional bedside clinical airway assessment tests (Modified Mallampati Test, thyromental distance, inter-incisor gap, upper lip bite test) show limited sensitivity (0.38-0.52) and specificity (0.83-0.86) for predicting difficult intubation. These patients routinely undergo comprehensive imaging (X-ray, CT, MRI) for surgical planning, which can be leveraged for objective airway assessment without additional procedures or costs.

Study Hypothesis: Specific radiological parameters from routine preoperative imaging will significantly associate with difficult video-laryngoscopy guided intubation in upper cervical spine patients.

Methods: At least 55 patients aged 18-65 years with ASA I-III status scheduled for elective upper cervical spine (C1-C4) surgery will be enrolled after IEC approval. Radiological parameters will be measured by an experienced radiologist blinded to clinical assessment: (1) X-ray parameters - LMHT, atlantooccipital distance (O-C1), C1-C2 distance, cervical angles; (2) CT parameters - radiological thyromental distance, retropharyngeal space dimensions; (3) MRI parameters - tongue thickness, oral cavity area, tongue area, TA/OCA ratio, retropharyngeal space dimensions. Traditional clinical airway assessment (MMT, TMD, IIG, ULBT) will be performed preoperatively. Standardized video-laryngoscopy (C-MAC) with manual in-line stabilization will be performed by experienced anaesthesiologist (>3 years) blinded to radiological measurements.

Primary Outcome: Incidence of difficult video-guided intubation defined as >1 intubation attempt OR intubation time >60 seconds.

Secondary Outcomes: (1) Incidence of difficult video-laryngoscopy (Cormack-Lehane Grade III-IV or POGO score <25%); (2) Quantification of radiological measurements; (3) Comparison of sensitivity, specificity, PPV, and NPV of radiological parameters versus traditional clinical tests.

Statistical Analysis: Categorical variables will be compared using chi-square or Fisher’s exact test; continuous variables using Student’s t-test or Mann-Whitney test. Univariate and multivariate logistic regression, ROC curve analysis will determine predictive accuracy. Statistical significance set at p<0.05.

Clinical Significance: This study will establish objective, validated radiological predictors for difficult video-laryngoscopy in high-risk cervical spine patients using existing standard-of-care imaging, potentially improving preoperative planning, reducing naesthesia-related complications, and enhancing patient safety without additional healthcare costs.

 
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