| CTRI Number |
CTRI/2025/02/080463 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of Airway using Ultrasound and Clinical airway tests |
|
Scientific Title of Study
|
Comparative Assessment of Airway using Ultrasound and Conventional method : A Prospective Observational Study in SMS Medical College, Jaipur. |
| 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 Indu Verma |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College and Hospitals |
| Address |
Department of Anaesthesia,
SMS Medical College and Hospital,
JLN Marg,
Jaipur
Jaipur RAJASTHAN 302002 India |
| Phone |
9413622967 |
| Fax |
|
| Email |
dr.induverma@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Indu Verma |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College and Hospitals |
| Address |
Department of Anaesthesia,
SMS Medical College and Hospital,
JLN Marg,
Jaipur
Jaipur RAJASTHAN 302002 India |
| Phone |
9413622967 |
| Fax |
|
| Email |
dr.induverma@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rupanchakravarthy S |
| Designation |
Junior Resident |
| Affiliation |
SAWAI MANSINGH MEDICAL COLLEGE |
| Address |
Department of Anaesthesia,
SMS Medical College and Hospital,
JLN Marg,
Jaipur
Jaipur RAJASTHAN 302002 India |
| Phone |
9597099455 |
| Fax |
|
| Email |
rupandgl4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia,
SMS Medical College and Hospitals,
JLN Marg,
Jaipur,
Rajasthan 302002
|
|
|
Primary Sponsor
|
| Name |
SMS Medical College and Hospitals |
| Address |
Department of Anaesthesia,
SMS Medical College and Hospital,
JLN Marg,
Jaipur,
Rajasthan-302002
|
| Type of Sponsor |
Government medical college |
|
|
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 Indu Verma |
Cardiac OT, SMS Medical College and Hospitals |
Department of Anaesthesia,2nd floor,
Dhanvantri Complex,
SMS Medical College and Hospital,
Jaipur
Jaipur RAJASTHAN |
9413622967
dr.induverma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Ethics Committee, SMS Medical College, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I257||Atherosclerosis of coronary arterybypass graft(s) and coronary artery of transplanted heart with angina pectoris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional methods and Ultrasonography measurements. |
comparing Conventional methods like Mallampatti score, thyromental distance with ultrasonography measurement of skin to epiglottis distance. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society of Anaesthesiologists (ASA) physical status classification score of I - III
2. Patient’s body mass index less than 40kg/m2
3. Patients undergoing elective surgical procedure requiring endotracheal intubation
|
|
| ExclusionCriteria |
| Details |
1. Patient not willing to give consent
2. Pre-existing airway malformations
3. Pathologies like facial or cervical fractures, maxilla facial abnormalities, cervical tumors and goiter
4. History of difficult intubation
5. Patients with tracheostomy tubes
6. Pregnant patients
7. Patients with body mass index more than 40kg/m2
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Find the Effectiveness of Sonographic Measurement of the Distance from the Skin to the Epiglottis in Predicting Difficult Laryngoscopy. |
To Find the Effectiveness of Sonographic Measurement of the Distance from the Skin to the Epiglottis in Predicting Difficult Laryngoscopy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To clinically assess the thyromental distance & Mallampati score for predicting difficult intubation.
2.To assess the Cormack-Lehane score for predicting difficult intubation during laryngoscopy. |
1.To clinically assess the thyromental distance & Mallampati score for predicting difficult intubation.
2.To assess the Cormack-Lehane score for predicting difficult intubation during laryngoscopy. |
|
|
Target Sample Size
|
Total Sample Size="126" Sample Size from India="126"
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)
|
01/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
09/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="4" 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
|
Patient arrival in pre anesthetic room, identification of patient and demographic details obtained The following preanesthetic evaluations are done, 1. Any significant present/past medical or surgical history, any drug allergy history 2. General physical examination 3. Clinical tests in airway examination 4. Ultrasonography measurement of skin to epiglottis distance Vital parameters like B.P., Pulse, SpO2, Temperature, Respiratory rate Routine investigations: Hb, TLC, DLC, Bleeding Time, Clotting Time, PT-INR, Fasting blood sugar, Serum urea, Serum creatinine, SGOT, SGPT, Serum Electrolytes, Chest X-Ray, ECG, 2D-ECHO, coronary artery angiography (if required) Patient received in OT identified, consent, NBM checked, monitored with ECG, NABP, pulse oximetry and capnography Preoxygenation will be done with 100% oxygen for 3-5 minutes. Anesthesia will be induced with Injection Propofol 2mg /kg and Injection Rocuronium Bromide 0.8 mg/kg IV, ventilated with oxygen and isoflurane 1.5% for 3min. Direct laryngoscopy is done with appropriate Macintosh blade by an anesthesiologist with more than 2 years of experience (post qualification) Cormack Lehane (CL) laryngoscopic grade was noted, Position of tube will be checked by 5-point auscultation method & capnography. Intubating anesthesiologist was not involved in preoperative airway evaluation (clinical tests and sonographic airway assessment Anesthesia maintained with isoflurane, booster doses of rocuronium and fentanyl as needed. Based on the preoperative airway findings, intubation is categorized as either easy or difficult, with the aim of determining which factor is the better predictor of airway difficulty. |