| CTRI Number |
CTRI/2025/06/088563 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
02/06/2025 |
| 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 post extubation stridor in neurosurgical patients using ultrasonographic parameters |
|
Scientific Title of Study
|
Efficacy Of Sonographic Measurement Of Laryngeal Air Column Width And Laryngeal Air Column Difference For Predicting Post Extubation Stridor in neurosurgical patients. |
| 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 Smita V |
| Designation |
Professor |
| Affiliation |
SREECHITHRA THIRUNAL INSTITUTE OF MEDICAL SCIENCES AND TECHNOLOGY |
| Address |
division of neuroanaesthesia,
department of anaesthesiology
C block
sctimst
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9447699245 |
| Fax |
|
| Email |
smita_vimala@sctimst.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Harsha Suresh P |
| Designation |
senior resident |
| Affiliation |
SREECHITHRA THIRUNAL INSTITUTE OF MEDICAL SCIENCES AND TECHNOLOGY |
| Address |
division of neuroanaesthesia,
department of anaesthesiology
C block
sctimst
Thiruvananthapuram
KERALA
695011
India |
| Phone |
09447773095 |
| Fax |
|
| Email |
hsp666@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smita V |
| Designation |
Professor |
| Affiliation |
SREECHITHRA THIRUNAL INSTITUTE OF MEDICAL SCIENCES AND TECHNOLOGY |
| Address |
division of neuroanaesthesia,
department of anaesthesiology
C block
sctimst
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9447699245 |
| Fax |
|
| Email |
smita_vimala@sctimst.ac.in |
|
|
Source of Monetary or Material Support
|
| sreechitra institute of medical sciences and technology,thiruvananthappuram,kerala,India-690511 |
|
|
Primary Sponsor
|
| Name |
academic division |
| Address |
sreechitra institute of medical sciences,thiruvanathappuram,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 smita V |
SCTIMST |
DIVISION OF NEUROANAESTHESIA
DEPARTMENT OF ANAESTHESIOLOGY
SCTIMST
Thiruvananthapuram
KERALA |
9447699245
smita_vimala@sctimst.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE ,SCTIMST,THIRUVANATHAPPURAM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C729||Malignant neoplasm of central nervous system, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted and undergoing neurosurgical procedures at Sree Chitra Tirunal Institute for Medical Sciences and Technology |
|
| ExclusionCriteria |
| Details |
1.Patient refusal or refusal by patient bystanders
2. Patients with a history of any airway related
surgeries
3.Patient with history of previous tracheostomy
4. Patients that will undergo elective tracheostomy
5. Patients undergoing emergency surgeries
6. Pregnant and lactating mothers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stridor |
Within 1st 24 hour of postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO FIND OUT THE RISK FACTORS FOR POSTEXTUBATION STRIDOR IN NEUROSURGICAL CASES |
24HOURS POST EXTUBATION |
|
|
Target Sample Size
|
Total Sample Size="257"
Sample Size from India="257"
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)
|
26/06/2025 |
| 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="1"
Months="6"
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
|
Post extubation stridor is a respiratory complication after removal of endotracheal tube.Ultrasound measured laryngeal air column width difference has emerged as non invasive technique with promising results in predicting post extubation stridor.Planing to conduct an observational study on efficacy of sonograghic measurement of laryngeal aircolumn width and laryngeal air column difference for predicting post extubation stridor in neurosurgical patients as unique risk factors for post extubation stridor due to lower cranial handling,pinning of head and positioning is there in neurosurgical patients. |