| CTRI Number |
CTRI/2025/03/083752 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study for predicting difficult airway in neurosurgical patients using ultrasonographic parameters |
|
Scientific Title of Study
|
Assessment pf ultrasonographic parameters as preoperative predictor of difficult intubation in neurosurgical patients: 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 Unnikrishnan P |
| Designation |
Additional Professor |
| Affiliation |
Sree Chitra Tirunal Institute For Medical Sciences & Technology |
| Address |
Department of Neuroanaesthesia
Room No 3116, C Block,
SCTIMST
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9447662321 |
| Fax |
|
| Email |
drunniz@sctimst.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Chandini Sunillal |
| Designation |
Senior resident |
| Affiliation |
Sree Chitra Tirunal Institute For Medical Sciences and Technology |
| Address |
DEPARTMENRT OF NEUROANAESTHESIA
ROOM NO 3402, C BLOCK,
SCTIMST
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9447904194 |
| Fax |
|
| Email |
drchandinisunil@sctimst.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Unnikrishnan P |
| Designation |
Additional Professor |
| Affiliation |
Sree Chitra Tirunal Institute For Medical Sciences and Technology |
| Address |
Department of Neuroanaesthesia
Room no 3116, C Block,
SCTIMST
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9447662321 |
| Fax |
|
| Email |
drunniz@sctimst.ac.in |
|
|
Source of Monetary or Material Support
|
| Sree Chitra Tirunal Institute For Medical Sciences and Technology Thiruvananthapuram Kerala India |
|
|
Primary Sponsor
|
| Name |
Academic divisionSree Chitra Tirunal Institute for Medical Sciences and Technology |
| Address |
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum,Kerala ,India-695011 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR UNNIKRISHNAN P |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
Neurosurgery OT , 4th floor,Sree Chitra Tirunal Institute for Medical Sciences and Technology
Thiruvananthapuram
KERALA |
9447662321
drunniz@sctimst.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sree chitra Thirunal institute for medical sciences and technology, Trivandrum,695011 KERALA INDIA, INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z018||Encounter for other specified special examinations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Consenting adult patients undergoing neurosurgical procedures at SCTIMST
Age 12 years and above
Both gender
ASA (American Society of Anaesthesiologists) classes 1,2 and 3
GCS 15/15 before the surgery. |
|
| ExclusionCriteria |
| Details |
Patient refusal
Age less than 12 years
Emergency surgery
Patients with cervical spine instability • ASA class 4,5 patients
Pregnant and lactating mothers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary aim of our study is to assess the correlation between ultrasound parameters and CL grading for predicting difficult intubation preoperatively in neurosurgical patients. |
21 months for recruitment
3 months for data analysis and compilation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the correlation of ultrasound parameters with clinical parameters and CL grading in predicting difficult airway preoperatively in neurosurgical patients. |
24 months |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
15/04/2025 |
| 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="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
|
We plan to conduct a prospective observational study to assess the correlation between ultrasound parameters and CL (Cormack Lehane)grading for predicting difficult intubation preoperatively in neurosurgical patients.Our secondary objective is to assess the correlation of ultrasound parameters with clinical parameters and CL grading in predicting difficult airway preoperatively in neurosurgical patients. |