| CTRI Number |
CTRI/2025/11/097226 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
08/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess how effective ultrasound is in confirming correct placement and position of a breathing tube(endotracheal tube) in adult patients receiving general anaesthesia |
|
Scientific Title of Study
|
Efficacy of ultrasound in confirmation of Endotracheal Intubation and position in adult patients undergoing general anaesthesia: a cross-sectional 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 |
Richardson Thongam |
| Designation |
Post graduate trainee |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Anaesthesiology Regional Institute of Medical Sciences Imphal Manipur
Imphal West
MANIPUR
795001
India |
| Phone |
8119875023 |
| Fax |
|
| Email |
thongamrichardson@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Richardson Thongam |
| Designation |
Post graduate trainee |
| Affiliation |
Department of Anaesthesiology Regional Institute of Medical Sciences |
| Address |
Department of Anaesthesiology Regional Institute of Medical Sciences Imphal Manipur
Imphal West
MANIPUR
795001
India |
| Phone |
8119875023 |
| Fax |
|
| Email |
thongamrichardson@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr L Chaoba Singh |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences Imphal Manipur |
| Address |
Department of Anaesthesiology Regional Institute of Medical Sciences Imphal Manipur
Imphal West
MANIPUR
795001
India |
| Phone |
9436022521 |
| Fax |
|
| Email |
drchaoba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology Regional Institute of Medical Sciences Imphal Manipur India 795001 |
|
|
Primary Sponsor
|
| Name |
Regional Institute of Medical Sciences |
| Address |
Department of Anaesthesiology Regional Institute of Medical Sciences Imphal Manipur 795001 |
| 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 Richardson Thongam |
Regional Institute of Medical Sciences Imphal Manipur |
Operation Theatre Complex Department of Anaesthesiology Regional Institute of Medical Sciences Imphal Manipur
Imphal West
MANIPUR |
8119875023
thongamrichardson@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board Regional Institute of Medical Sciences Imphal Manipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age group 18 to 60years.
2. Patients of any gender
3. Patients of American Society of Anaesthesiologists Physical State (ASA) grade I or II.
4. Mallampati grade I & II
|
|
| ExclusionCriteria |
| Details |
1. Patients with active infections or burns over the neck
2. Pregnant females
3. Patients with suspected or diagnosed cervical spine instability
4. Patients with active upper respiratory tract infection
5. Patients with congenital upper airway anomalies
6. Patients with body mass index (BMI) more than or equal to 30kgm-2
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• To evaluate the efficacy of upper airway ultrasound for confirmation of successful endotracheal intubation.
• To determine the accuracy of the ultrasound image confirming the proper depth of the endotracheal tube.
|
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
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)
|
15/12/2025 |
| 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
|
Endotracheal intubation is a fundamental component of
airway management in both elective surgeries and emergency care. Ensuring
correct placement of the endotracheal tube (ETT) is essential, as malposition can
lead to severe complications. An optimal ETT placement should ensure sufficient
distance (2-5 cm) between the tip of the ETT and the carina. Upper airway
ultrasonography being used in real time during intubation to detect tracheal
placement by the loss of “snowstorm sign” and to assess ETT depth using a
saline-filled cuff technique. The ultrasound of saline-filled cuff technique is
a rapid and reliable method, involves no radiation, requires no patient
positioning, and can be done as many times as needed.
This study will be a prospective observational
clinical trial to assess the efficacy of ultrasound in confirmation of
endotracheal tube intubation and confirmation of endotracheal tube position in
adult patients undergoing general anaesthesia. After approval from the Research
Ethics Board of RIMS, Imphal, a total number of 51 patients (18-60 years, ASA I
and II, Mallampati class I and II) will be enrolled after taking written
informed consent from the patients. Endotracheal intubation will be performed
under suitable conditions. With upper airway ultrasound, confirmation of the
endotracheal intubation using linear probe (4-12 Hz) in real time during
intubation by detecting loss of snow storm sign and double trachea sign will be
done. After confirmation of endotracheal intubation 10 ml of normal saline will
be infused into the cuff and proximal end of the saline filled cuff of the
endotracheal tube will be fixed at T3in neutral head and neck position. Tip
to carina distance will be measured using flexible fiberoptic bronchoscope.
Presence or absence of Snow storm sign, Double trachea
sign, Wave capnography, tip to Carina distance will be observed as
outcomes. Data will be recorded will be analyzed using SPSS V.26.0
(Chicago, Illinois, USA)software. Ap
value of < 0.05 will be considered statistically significant. |