| 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 |
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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 |
|
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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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
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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
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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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 |
|
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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. |