| CTRI Number |
CTRI/2026/01/102125 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ultrasound and capnography for confirming correct breathing tube placement in patients undergoing elective surgery |
|
Scientific Title of Study
|
Comparative evaluation of ultrasonography and capnography to confirm endotracheal intubation in patients undergoing elective surgeries |
| 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 SOPHIA SABA |
| Designation |
PG Resident |
| Affiliation |
Career Institute Of Medical Sciences And Hospital Lucknow |
| Address |
Department Of Anesthesiology
Career Institute Of Medical Sciences And Hospital Lucknow
IIM Road Ghaila Lucknow
Lucknow UTTAR PRADESH 226013 India |
| Phone |
9958937808 |
| Fax |
|
| Email |
saba.sophia35@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR. PRIYESH BHASKAR |
| Designation |
Professor And Head Of Department Of Anesthesiology |
| Affiliation |
Career Institute Of Medical Sciences And Hospital Lucknow |
| Address |
Department of Anaesthesiology, Operation Theatre Complex, Career Institute Of Medical Sciences And Hospital, Lucknow
Lucknow UTTAR PRADESH 226013 India |
| Phone |
7985975077 |
| Fax |
|
| Email |
drpriyeshlpsc@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR SOPHIA SABA |
| Designation |
PG Resident |
| Affiliation |
Career Institute Of Medical Sciences And Hospital Lucknow |
| Address |
Department Of Anesthesiology
Career Institute Of Medical Sciences And Hospital Lucknow
IIM Road Ghaila Lucknow
Lucknow UTTAR PRADESH 226013 India |
| Phone |
9958937808 |
| Fax |
|
| Email |
saba.sophia35@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Career Institute Of Medical Sciences And Hospital Lucknow |
| Address |
Career Institute Of Medical Sciences And Hospital
IIM Road Ghaila Lucknow Uttar Pradesh |
| Type of Sponsor |
Private 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 Sophia Saba |
Career Institute Of Medical Sciences And Hospital |
Resident room no 1, Division 1, Department of Anesthesia, Operation Theatre Complex Lucknow UTTAR PRADESH |
9958937808
saba.sophia35@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Career Institute Of Medical Sciences And Hospital Lucknow |
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 |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either gender aged eighteen to sixty five years. Patients scheduled to undergo elective surgical procedures under general anaesthesia requiring endotracheal intubation. American Society of Anaesthesiologists physical status class one and two. Patients willing to give written informed consent. |
|
| ExclusionCriteria |
| Details |
Patients requiring awake intubation. Patients with abnormal airway anatomy such as Mallampati grade three or four, thyromental distance less than six point five centimetres, mouth opening less than three centimetres, neck circumference more than forty centimetres or facial deformity. History of difficult tracheal intubation. Patients with high risk of aspiration including obstetric patients, emergency surgery, trauma patients, patients with decreased consciousness or obesity with body mass index more than thirty kilogram per square metre. Patients with severe cardiac, pulmonary, hepatic, renal or coagulation disorders. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accuracy, rapidity and reliability of ultrasonography, capnography and clinical methods in confirming correct endotracheal tube placement |
Immediately after endotracheal intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
05/02/2026 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
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 study to compare ultrasonography, capnography and clinical methods for confirmation of correct endotracheal tube placement in patients undergoing elective surgeries under general anaesthesia. Adult patients aged eighteen to sixty five years belonging to American Society of Anaesthesiologists physical status class one and two will be enrolled. After routine endotracheal intubation, tube position will be assessed using clinical examination, capnography and ultrasonography. The primary outcome will be accuracy, rapidity and reliability of each method in confirming correct tube placement. The study aims to identify the most efficient and reliable method for confirmation of endotracheal intubation in elective surgical patients. |