| CTRI Number |
CTRI/2025/04/083812 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
OBSERVATIONAL |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Using ultrasound at the bedside to identify the best nostril for nasotracheal intubation |
|
Scientific Title of Study
|
Point of care ultrasound for predicting suitable nostril for nasotracheal intubation - An 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 VANSHIKA SARANGA |
| Designation |
Junior Resident |
| Affiliation |
KLE DR Prabhakar Kore Hospital |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, JAWAHARLAL NEHRU MEDICAL COLLEGE,BELAGAVI, KARNATAKA.
DEPARTMENT OF ANAESTHESIOLOGY, JAWAHARLAL NEHRU MEDICAL COLLEGE, BELAGAVI,KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
9000942115 |
| Fax |
|
| Email |
svanshika2022@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAGHAVENDRA KALAL |
| Designation |
Assistant Professor |
| Affiliation |
KLE DR Prabhakar Kore Hospital |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, JAWAHARLAL NEHRU MEDICAL COLLEGE, BELAGAVI, KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
9880712568 |
| Fax |
|
| Email |
dr.raghavendra.kalal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAGHAVENDRA KALAL |
| Designation |
Assistant Professor |
| Affiliation |
KLE DR Prabhakar Kore Hospital |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, JAWAHARLAL NEHRU MEDICAL COLLEGE, BELAGAVI, KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
9880712568 |
| Fax |
|
| Email |
dr.raghavendra.kalal@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY, JAWAHARLAL NEHRU MEICAL COLLEGE ,BELAGAVI ,KARNATAKA ,590010 |
|
|
Primary Sponsor
|
| Name |
DR VANSHIKA SARANGA |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, JAWAHARLAL NEHRU MEDICAL COLLEGE, BELAGAVI, KARNATAKA |
| Type of Sponsor |
Other [Self] |
|
|
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 VANSHIKA SARANGA |
KLE DR PRABHAKAR KORE HOSPITAL |
DEPARTMENT OFANAESTHESIOLOGY, JAWAHARLAL NEHRU MEDICAL COLLEGE, BELAGAVI , KARNATAKA
Belgaum
KARNATAKA |
9000942115
svanshika2022@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
USG group |
USG is used for predicting the suitable nostril for passing the nasotracheal tube for nasotracheal intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who give consent.
ASA I & II patients.
Age group between 18-70 years of either sex.
Elective head and neck surgeries.
Patients in need of nasotracheal intubation under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patient refusal.
Emergency surgery.
Pre exsisting epistaxsis.
Deranged coagulation profile. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Utilizing ultrasound to near predict the reserve of deviated nasal septum and determine the optimal nostril for nasotracheal tube insertion |
Done at the bedside before patient shifted to operation theater |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To predict the appropriate size of nasotracheal tube in patients to avoid multiple attempts of intubation & associated trauma |
Done at bedside before patient shifted to operation theater
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
02/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The use of point-of-care nasal ultrasound as a tool to predict which nostril is more suitable for nasotracheal intubation. Nasotracheal intubation involves inserting a tube through the nose to secure the airway. Ultrasound imaging can be performed at the patient’s bedside (point-of-care) to assess the anatomy of the nasal passages, helping anesthesiologist to determine which side of the nose might be more optimal for the procedure, based on the side of deviation of nasal septum.This technique can improve the success rate and safety of the procedure. |